Trial Outcomes & Findings for Combined Treatment for Mixed Incontinence (NCT NCT01959347)

NCT ID: NCT01959347

Last Updated: 2020-05-14

Results Overview

The Urogenital Distress Inventory (UDI) is a standardized a measure of overactive bladder symptoms and health-related quality of life. The UDI scale has a range from 0 to 300 with higher scores indicating greater distress. The change from baseline outcome is calculated as the difference in score at 3, 6, or 12 months and the score at baseline.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

480 participants

Primary outcome timeframe

3, 6, and 12 Months

Results posted on

2020-05-14

Participant Flow

Participant milestones

Participant milestones
Measure	MUS Only Midurethral sling alone	MUS+BPTx Midurethral sling and behavioral/pelvic floor therapy
Overall Study STARTED	238	242
Overall Study COMPLETED	229	235
Overall Study NOT COMPLETED	9	7

Reasons for withdrawal

Reasons for withdrawal
Measure	MUS Only Midurethral sling alone	MUS+BPTx Midurethral sling and behavioral/pelvic floor therapy
Overall Study Protocol Violation	9	7

Baseline Characteristics

Combined Treatment for Mixed Incontinence

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	MUS Only n=229 Participants Midurethral sling alone	MUS+BPTx n=235 Participants Midurethral sling and behavioral/pelvic floor therapy	Total n=464 Participants Total of all reporting groups
Age, Continuous	53.6 years STANDARD_DEVIATION 10.4 • n=99 Participants	54.3 years STANDARD_DEVIATION 11 • n=107 Participants	54 years STANDARD_DEVIATION 10.7 • n=206 Participants
Sex/Gender, Customized Female	229 Participants n=99 Participants	235 Participants n=107 Participants	464 Participants n=206 Participants
Race/Ethnicity, Customized American Indian/Alaskan Native	3 Participants n=99 Participants	7 Participants n=107 Participants	10 Participants n=206 Participants
Race/Ethnicity, Customized Asian	1 Participants n=99 Participants	2 Participants n=107 Participants	3 Participants n=206 Participants
Race/Ethnicity, Customized Black/African American	19 Participants n=99 Participants	22 Participants n=107 Participants	41 Participants n=206 Participants
Race/Ethnicity, Customized More than one race	1 Participants n=99 Participants	2 Participants n=107 Participants	3 Participants n=206 Participants
Race/Ethnicity, Customized Other	23 Participants n=99 Participants	19 Participants n=107 Participants	42 Participants n=206 Participants
Race/Ethnicity, Customized Unknown/Not Reported	4 Participants n=99 Participants	2 Participants n=107 Participants	6 Participants n=206 Participants
Race/Ethnicity, Customized White	181 Participants n=99 Participants	181 Participants n=107 Participants	362 Participants n=206 Participants
Race/Ethnicity, Customized Hispanic/Latina	56 Participants n=99 Participants	49 Participants n=107 Participants	105 Participants n=206 Participants
Race/Ethnicity, Customized Not Hispanic/Not Latina	169 Participants n=99 Participants	184 Participants n=107 Participants	353 Participants n=206 Participants
Body Mass Index	32.3 kg/m^2 STANDARD_DEVIATION 7 • n=99 Participants	31.7 kg/m^2 STANDARD_DEVIATION 7 • n=107 Participants	32 kg/m^2 STANDARD_DEVIATION 7 • n=206 Participants
Current Smoker No	200 Participants n=99 Participants	203 Participants n=107 Participants	403 Participants n=206 Participants
Current Smoker Yes	28 Participants n=99 Participants	32 Participants n=107 Participants	60 Participants n=206 Participants
Current Smoker Unknown or Not Reported	1 Participants n=99 Participants	0 Participants n=107 Participants	1 Participants n=206 Participants
Ever Pregnant No	10 Participants n=99 Participants	15 Participants n=107 Participants	25 Participants n=206 Participants
Ever Pregnant Yes	218 Participants n=99 Participants	220 Participants n=107 Participants	438 Participants n=206 Participants
Ever Pregnant Unknown or Not Reported	1 Participants n=99 Participants	0 Participants n=107 Participants	1 Participants n=206 Participants
Number of Vaginal Deliveries	2 Number of deliveries n=99 Participants	2 Number of deliveries n=107 Participants	2 Number of deliveries n=206 Participants
Number of Cesarean Deliveries	0 Number of deliveries n=99 Participants	0 Number of deliveries n=107 Participants	0 Number of deliveries n=206 Participants
Menstrual Status not sure	28 Participants n=99 Participants	32 Participants n=107 Participants	60 Participants n=206 Participants
Menstrual Status post-menopausal	124 Participants n=99 Participants	138 Participants n=107 Participants	262 Participants n=206 Participants
Menstrual Status pre-menopausal	76 Participants n=99 Participants	65 Participants n=107 Participants	141 Participants n=206 Participants
Menstrual Status Unknown or Not Reported	1 Participants n=99 Participants	0 Participants n=107 Participants	1 Participants n=206 Participants

PRIMARY outcome

Timeframe: 3, 6, and 12 Months

Population: An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed. Data that was collected after a participant was retreated for urinary incontinence was excluded from the analysis.

Outcome measures

Outcome measures
Measure	MUS Only n=229 Participants Midurethral sling alone	MUS+BPTx n=235 Participants Midurethral sling and behavioral/pelvic floor therapy
Change From Baseline UDI Total Score 3 Months	-138.8 units on a scale Interval -145.9 to -131.7	-142.7 units on a scale Interval -150.7 to -134.8
Change From Baseline UDI Total Score 6 Months	-137 units on a scale Interval -145.0 to -128.9	-147.4 units on a scale Interval -155.4 to -139.4
Change From Baseline UDI Total Score 12 Months	-137.9 units on a scale Interval -145.9 to -129.8	-147.7 units on a scale Interval -156.4 to -139.0

SECONDARY outcome

Timeframe: 3, 6, and 12 Months

The Urogenital Distress Inventory is a standardized a measure of overactive bladder symptoms and health-related quality of life. The UDI Stress subscale has a range from 0 to 100 with higher scores indicating greater distress. The change from baseline outcome is calculated as the difference in score at 3, 6, or 12 months and the score at baseline.

Outcome measures

Outcome measures
Measure	MUS Only n=229 Participants Midurethral sling alone	MUS+BPTx n=235 Participants Midurethral sling and behavioral/pelvic floor therapy
Change From Baseline UDI Stress Score 3 Months	-70.6 units on a scale Interval -74.1 to -67.1	-72.5 units on a scale Interval -76.4 to -68.6
Change From Baseline UDI Stress Score 6 Months	-69.5 units on a scale Interval -73.8 to -65.2	-72.8 units on a scale Interval -76.7 to -68.8
Change From Baseline UDI Stress Score 12 Months	-69.3 units on a scale Interval -73.7 to -65.0	-73.8 units on a scale Interval -78.0 to -69.6

SECONDARY outcome

Timeframe: 3, 6, and 12 Months

The Urogenital Distress Inventory is a standardized a measure of overactive bladder symptoms and health-related quality of life. The UDI Irritative subscale has a range from 0 to 100 with higher scores indicating greater distress. The change from baseline outcome is calculated as the difference in score at 3, 6, or 12 months and the score at baseline.

Outcome measures

Outcome measures
Measure	MUS Only n=229 Participants Midurethral sling alone	MUS+BPTx n=235 Participants Midurethral sling and behavioral/pelvic floor therapy
Change From Baseline UDI Irritative Score 3 Months	-49.7 units on a scale Interval -53.3 to -46.2	-50.1 units on a scale Interval -53.6 to -46.6
Change From Baseline UDI Irritative Score 6 Months	-49.5 units on a scale Interval -53.2 to -45.7	-53.5 units on a scale Interval -56.9 to -50.1
Change From Baseline UDI Irritative Score 12 Months	-50 units on a scale Interval -53.6 to -46.4	-53.5 units on a scale Interval -57.1 to -49.9

SECONDARY outcome

Timeframe: 3, 6, and 12 Months

The Urogenital Distress Inventory is a standardized a measure of overactive bladder symptoms and health-related quality of life. The UDI Obstructive subscale has a range from 0 to 100 with higher scores indicating greater distress. The change from baseline outcome is calculated as the difference in score at 3, 6, or 12 months and the score at baseline.

Outcome measures

Outcome measures
Measure	MUS Only n=229 Participants Midurethral sling alone	MUS+BPTx n=235 Participants Midurethral sling and behavioral/pelvic floor therapy
Change From Baseline UDI Obstructive Score 3 Months	-18.5 units on a scale Interval -20.9 to -16.0	-20.2 units on a scale Interval -23.4 to -16.9
Change From Baseline UDI Obstructive Score 6 Months	-18 units on a scale Interval -20.6 to -15.4	-21.1 units on a scale Interval -24.2 to -18.0
Change From Baseline UDI Obstructive Score 12 Months	-18.5 units on a scale Interval -21.1 to -15.9	-20.3 units on a scale Interval -23.7 to -17.0

OTHER_PRE_SPECIFIED outcome

Timeframe: 2 weeks and 2, 6, and 12 Months

Based on data collected from participant-completed diaries at baseline, 2 weeks, and 2, 6, and 12 months, the outcome variable is computed as the difference in number of stress incontinence episodes at 2 weeks, 2, 6, or 12 months and the number of stress incontinence episodes at baseline.

Outcome measures

Outcome measures
Measure	MUS Only n=229 Participants Midurethral sling alone	MUS+BPTx n=235 Participants Midurethral sling and behavioral/pelvic floor therapy
Change From Baseline Number of Stress Incontinence Episodes 0.5 Months	-2.2 number of episodes Interval -2.4 to -1.9	-2.2 number of episodes Interval -2.6 to -1.9
Change From Baseline Number of Stress Incontinence Episodes 2 Months	-2.3 number of episodes Interval -2.6 to -2.1	-2.4 number of episodes Interval -2.7 to -2.0
Change From Baseline Number of Stress Incontinence Episodes 6 Months	-2.3 number of episodes Interval -2.6 to -2.0	-2.3 number of episodes Interval -2.6 to -2.0
Change From Baseline Number of Stress Incontinence Episodes 12 Months	-2.2 number of episodes Interval -2.5 to -2.0	-2.2 number of episodes Interval -2.6 to -1.9

OTHER_PRE_SPECIFIED outcome

Timeframe: 2 weeks and 2, 6, and 12 Months

Based on data collected from participant-completed diaries at baseline, 2 weeks, and 2, 6, and 12 months, the outcome variable is computed as the difference in number of urge incontinence episodes at 2 weeks, 2, 6, or 12 months and the number of urge incontinence episodes at baseline.

Outcome measures

Outcome measures
Measure	MUS Only n=229 Participants Midurethral sling alone	MUS+BPTx n=235 Participants Midurethral sling and behavioral/pelvic floor therapy
Change From Baseline Number of Urge Incontinence Episodes 0.5 Months	-1.8 number of episodes Interval -2.2 to -1.5	-1.7 number of episodes Interval -2.0 to -1.4
Change From Baseline Number of Urge Incontinence Episodes 2 Months	-2 number of episodes Interval -2.3 to -1.7	-2 number of episodes Interval -2.3 to -1.8
Change From Baseline Number of Urge Incontinence Episodes 6 Months	-2 number of episodes Interval -2.4 to -1.6	-2 number of episodes Interval -2.3 to -1.7
Change From Baseline Number of Urge Incontinence Episodes 12 Months	-1.9 number of episodes Interval -2.3 to -1.5	-2.2 number of episodes Interval -2.5 to -1.8

OTHER_PRE_SPECIFIED outcome

Timeframe: 2 weeks and 2, 6, and 12 Months

Based on data collected from participant-completed diaries at baseline, 2 weeks, and 2, 6, and 12 months, the outcome variable is computed as the difference in number of unknown incontinence episodes at 2 weeks, 2, 6, or 12 months and the number of unknown incontinence episodes at baseline.

Outcome measures

Outcome measures
Measure	MUS Only n=229 Participants Midurethral sling alone	MUS+BPTx n=235 Participants Midurethral sling and behavioral/pelvic floor therapy
Change From Baseline Number of Unknown Incontinence Episodes 0.5 Months	-0.2 number of episodes Interval -0.3 to 0.0	-0.4 number of episodes Interval -0.5 to -0.2
Change From Baseline Number of Unknown Incontinence Episodes 2 Months	-0.3 number of episodes Interval -0.5 to -0.2	-0.4 number of episodes Interval -0.6 to -0.2
Change From Baseline Number of Unknown Incontinence Episodes 6 Months	-0.3 number of episodes Interval -0.4 to -0.2	-0.4 number of episodes Interval -0.6 to -0.2
Change From Baseline Number of Unknown Incontinence Episodes 12 Months	-0.3 number of episodes Interval -0.4 to -0.1	-0.4 number of episodes Interval -0.6 to -0.2

OTHER_PRE_SPECIFIED outcome

Timeframe: 2 weeks and 2, 6, and 12 Months

Based on data collected from participant-completed diaries at baseline, 2 weeks, and 2, 6, and 12 months, the outcome variable is computed as the difference in total number of incontinence episodes at 2 weeks, 2, 6, or 12 months and the total number of incontinence episodes at baseline.

Outcome measures

Outcome measures
Measure	MUS Only n=229 Participants Midurethral sling alone	MUS+BPTx n=235 Participants Midurethral sling and behavioral/pelvic floor therapy
Change From Baseline Total Number of Incontinence Episodes 0.5 Months	-4.2 number of episodes Interval -4.7 to -3.7	-4.3 number of episodes Interval -4.8 to -3.8
Change From Baseline Total Number of Incontinence Episodes 2 Months	-4.7 number of episodes Interval -5.1 to -4.2	-4.8 number of episodes Interval -5.2 to -4.3
Change From Baseline Total Number of Incontinence Episodes 6 Months	-4.6 number of episodes Interval -5.1 to -4.1	-4.7 number of episodes Interval -5.2 to -4.3
Change From Baseline Total Number of Incontinence Episodes 12 Months	-4.4 number of episodes Interval -4.9 to -3.9	-4.8 number of episodes Interval -5.3 to -4.3

OTHER_PRE_SPECIFIED outcome

Timeframe: 2 weeks and 2, 6, and 12 Months

Based on data collected from participant-completed diaries at baseline, 2 weeks, and 2, 6, and 12 months, the outcome variable is computed as the difference in number of wet pads per day at 2 weeks, 2, 6, or 12 months and the number of wet pads per day at baseline.

Outcome measures

Outcome measures
Measure	MUS Only n=229 Participants Midurethral sling alone	MUS+BPTx n=235 Participants Midurethral sling and behavioral/pelvic floor therapy
Change From Baseline Number of Wet Pads Per Day 0.5 Months	-2 number of pads Interval -2.3 to -1.7	-2.2 number of pads Interval -2.6 to -1.8
Change From Baseline Number of Wet Pads Per Day 2 Months	-2.4 number of pads Interval -2.7 to -2.1	-2.7 number of pads Interval -3.1 to -2.2
Change From Baseline Number of Wet Pads Per Day 6 Months	-2.2 number of pads Interval -2.6 to -1.8	-2.7 number of pads Interval -3.1 to -2.2
Change From Baseline Number of Wet Pads Per Day 12 Months	-2.2 number of pads Interval -2.6 to -1.9	-2.7 number of pads Interval -3.1 to -2.2

OTHER_PRE_SPECIFIED outcome

Timeframe: 2 weeks and 2, 6, and 12 Months

Based on data collected from participant-completed diaries at baseline, 2 weeks, and 2, 6, and 12 months, the outcome variable is computed as the difference in total number of pads per day at 2 weeks, 2, 6, or 12 months and the total number of pads per day at baseline.

Outcome measures

Outcome measures
Measure	MUS Only n=229 Participants Midurethral sling alone	MUS+BPTx n=235 Participants Midurethral sling and behavioral/pelvic floor therapy
Change From Baseline Number of Pads Per Day 0.5 Months	-1.6 number of pads Interval -1.9 to -1.3	-1.9 number of pads Interval -2.3 to -1.5
Change From Baseline Number of Pads Per Day 2 Months	-2.2 number of pads Interval -2.6 to -1.9	-2.7 number of pads Interval -3.1 to -2.2
Change From Baseline Number of Pads Per Day 6 Months	-2.2 number of pads Interval -2.6 to -1.8	-2.8 number of pads Interval -3.3 to -2.3
Change From Baseline Number of Pads Per Day 12 Months	-2.3 number of pads Interval -2.7 to -2.0	-2.7 number of pads Interval -3.2 to -2.3

OTHER_PRE_SPECIFIED outcome

Timeframe: 2 weeks and 2, 6, and 12 Months

Based on data collected from participant-completed diaries at baseline, 2 weeks, and 2, 6, and 12 months, the outcome variable is computed as the difference in number of daytime voids at 2 weeks, 2, 6, or 12 months and the number of daytime voids at baseline.

Outcome measures

Outcome measures
Measure	MUS Only n=229 Participants Midurethral sling alone	MUS+BPTx n=235 Participants Midurethral sling and behavioral/pelvic floor therapy
Change From Baseline Number of Daytime Voids 0.5 Months	-0.6 number of voids Interval -1.0 to -0.3	-0.8 number of voids Interval -1.2 to -0.4
Change From Baseline Number of Daytime Voids 2 Months	-0.7 number of voids Interval -1.0 to -0.3	-1.6 number of voids Interval -1.9 to -1.2
Change From Baseline Number of Daytime Voids 6 Months	-1.1 number of voids Interval -1.4 to -0.7	-2.2 number of voids Interval -2.5 to -1.8
Change From Baseline Number of Daytime Voids 12 Months	-1.2 number of voids Interval -1.6 to -0.8	-2 number of voids Interval -2.4 to -1.7

OTHER_PRE_SPECIFIED outcome

Timeframe: 2 weeks and 2, 6, and 12 Months

Based on data collected from participant-completed diaries at baseline, 2 weeks, and 2, 6, and 12 months, the outcome variable is computed as the difference in number of nighttime voids at 2 weeks, 2, 6, or 12 months and the number of nighttime voids at baseline.

Outcome measures

Outcome measures
Measure	MUS Only n=229 Participants Midurethral sling alone	MUS+BPTx n=235 Participants Midurethral sling and behavioral/pelvic floor therapy
Change From Baseline Number of Nighttime Voids 0.5 Months	-0.2 number of voids Interval -0.4 to -0.1	-0.4 number of voids Interval -0.6 to -0.2
Change From Baseline Number of Nighttime Voids 2 Months	-0.4 number of voids Interval -0.6 to -0.3	-0.7 number of voids Interval -0.8 to -0.5
Change From Baseline Number of Nighttime Voids 6 Months	-0.5 number of voids Interval -0.7 to -0.4	-0.8 number of voids Interval -0.9 to -0.6
Change From Baseline Number of Nighttime Voids 12 Months	-0.4 number of voids Interval -0.6 to -0.2	-0.8 number of voids Interval -0.9 to -0.6

OTHER_PRE_SPECIFIED outcome

Timeframe: 2 weeks and 2, 6, and 12 Months

Based on data collected from participant-completed diaries at baseline, 2 weeks, and 2, 6, and 12 months, the outcome variable is computed as the difference in number of urgency voids without incontinence at 2 weeks, 2, 6, or 12 months and the number of urgency voids without incontinence at baseline.

Outcome measures

Outcome measures
Measure	MUS Only n=229 Participants Midurethral sling alone	MUS+BPTx n=235 Participants Midurethral sling and behavioral/pelvic floor therapy
Change From Baseline Number of Urgency Voids Without Incontinence 0.5 Months	-1.1 number of voids Interval -2.3 to 0.1	-0.8 number of voids Interval -2.2 to 0.6
Change From Baseline Number of Urgency Voids Without Incontinence 2 Months	-1.6 number of voids Interval -3.0 to -0.3	-4.3 number of voids Interval -5.8 to -2.8
Change From Baseline Number of Urgency Voids Without Incontinence 6 Months	-3.5 number of voids Interval -4.9 to -2.1	-4.8 number of voids Interval -6.4 to -3.1
Change From Baseline Number of Urgency Voids Without Incontinence 12 Months	-3.9 number of voids Interval -5.5 to -2.4	-5.1 number of voids Interval -6.6 to -3.7

OTHER_PRE_SPECIFIED outcome

Timeframe: 2 weeks and 2, 6, and 12 Months

Based on data collected from participant-completed diaries at baseline, 2 weeks, and 2, 6, and 12 months, for participants with \>8 voids at baseline, the outcome is calculated as Yes=no more than 8 voids noted at the time point, No=Otherwise

Outcome measures

Outcome measures
Measure	MUS Only n=229 Participants Midurethral sling alone	MUS+BPTx n=235 Participants Midurethral sling and behavioral/pelvic floor therapy
Number of Participants With <8 Voids After Baseline (Normalization of Voiding Frequency) 0.5 Months · Yes	48 Participants	59 Participants
Number of Participants With <8 Voids After Baseline (Normalization of Voiding Frequency) 0.5 Months · No	82 Participants	68 Participants
Number of Participants With <8 Voids After Baseline (Normalization of Voiding Frequency) 2 Months · Yes	49 Participants	81 Participants
Number of Participants With <8 Voids After Baseline (Normalization of Voiding Frequency) 2 Months · No	76 Participants	43 Participants
Number of Participants With <8 Voids After Baseline (Normalization of Voiding Frequency) 6 Months · Yes	46 Participants	79 Participants
Number of Participants With <8 Voids After Baseline (Normalization of Voiding Frequency) 6 Months · No	56 Participants	33 Participants
Number of Participants With <8 Voids After Baseline (Normalization of Voiding Frequency) 12 Months · Yes	48 Participants	80 Participants
Number of Participants With <8 Voids After Baseline (Normalization of Voiding Frequency) 12 Months · No	57 Participants	29 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 2 weeks and 2, 6, and 12 Months

Based on data collected from participant-completed diaries at baseline, 2 weeks, and 2, 6, and 12 months, the outcome is calculated as Yes=at least 50% reduction in the number of voids between 2 weeks, 2, 6, and 12 months and baseline, No=Otherwise

Outcome measures

Outcome measures
Measure	MUS Only n=229 Participants Midurethral sling alone	MUS+BPTx n=235 Participants Midurethral sling and behavioral/pelvic floor therapy
Number of Participants With 50% Reduction in Voids Relative to Baseline (Improved Voiding Frequency) 0.5 Months · Yes	1 Participants	8 Participants
Number of Participants With 50% Reduction in Voids Relative to Baseline (Improved Voiding Frequency) 0.5 Months · No	198 Participants	190 Participants
Number of Participants With 50% Reduction in Voids Relative to Baseline (Improved Voiding Frequency) 2 Months · Yes	2 Participants	13 Participants
Number of Participants With 50% Reduction in Voids Relative to Baseline (Improved Voiding Frequency) 2 Months · No	189 Participants	177 Participants
Number of Participants With 50% Reduction in Voids Relative to Baseline (Improved Voiding Frequency) 6 Months · Yes	6 Participants	15 Participants
Number of Participants With 50% Reduction in Voids Relative to Baseline (Improved Voiding Frequency) 6 Months · No	152 Participants	155 Participants
Number of Participants With 50% Reduction in Voids Relative to Baseline (Improved Voiding Frequency) 12 Months · Yes	8 Participants	15 Participants
Number of Participants With 50% Reduction in Voids Relative to Baseline (Improved Voiding Frequency) 12 Months · No	153 Participants	150 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 2 weeks and 2, 6, and 12 Months

Based on data collected from participant-completed diaries at baseline, 2 weeks, and 2, 6, and 12 months, the outcome is calculated as Yes=greater than baseline number of voids at the time point or with greater than 8 voids at the time point, No=Otherwise

Outcome measures

Outcome measures
Measure	MUS Only n=229 Participants Midurethral sling alone	MUS+BPTx n=235 Participants Midurethral sling and behavioral/pelvic floor therapy
Number of Participants With Greater Number of Voids Relative to Baseline or >8 Voids (Worsening Voiding Frequency) 0.5 Months · Yes	124 Participants	104 Participants
Number of Participants With Greater Number of Voids Relative to Baseline or >8 Voids (Worsening Voiding Frequency) 0.5 Months · No	75 Participants	94 Participants
Number of Participants With Greater Number of Voids Relative to Baseline or >8 Voids (Worsening Voiding Frequency) 2 Months · Yes	111 Participants	68 Participants
Number of Participants With Greater Number of Voids Relative to Baseline or >8 Voids (Worsening Voiding Frequency) 2 Months · No	80 Participants	122 Participants
Number of Participants With Greater Number of Voids Relative to Baseline or >8 Voids (Worsening Voiding Frequency) 6 Months · Yes	81 Participants	43 Participants
Number of Participants With Greater Number of Voids Relative to Baseline or >8 Voids (Worsening Voiding Frequency) 6 Months · No	77 Participants	127 Participants
Number of Participants With Greater Number of Voids Relative to Baseline or >8 Voids (Worsening Voiding Frequency) 12 Months · Yes	79 Participants	43 Participants
Number of Participants With Greater Number of Voids Relative to Baseline or >8 Voids (Worsening Voiding Frequency) 12 Months · No	82 Participants	122 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 3, 6, and 12 Months

The Pelvic Organ Prolapse Incontinence Sexual Questionnaire, IUGA-revised (PISQ-IR) is a questionnaire measuring the impact of incontinence symptoms on sexual function and satisfaction. Using the Rockwood scoring, the PISQ-IR Not Partner Related subscale (NSA-PR) ranges from 0 to 100 with higher scores indicating worse function/satisfaction. The change from baseline outcome is calculated as the difference in score at 3, 6, or 12 months and the score at baseline.

Outcome measures

Outcome measures
Measure	MUS Only n=229 Participants Midurethral sling alone	MUS+BPTx n=235 Participants Midurethral sling and behavioral/pelvic floor therapy
Change From Baseline PISQ-IR NSAPR Score 3 Months	7.1 units on a scale Interval -0.8 to 15.0	-8.8 units on a scale Interval -16.6 to -1.1
Change From Baseline PISQ-IR NSAPR Score 6 Months	5.5 units on a scale Interval -2.9 to 13.8	2.5 units on a scale Interval -7.6 to 12.6
Change From Baseline PISQ-IR NSAPR Score 12 Months	3.3 units on a scale Interval -6.9 to 13.6	2.3 units on a scale Interval -5.8 to 10.4

OTHER_PRE_SPECIFIED outcome

Timeframe: 3, 6, and 12 Months

The Pelvic Organ Prolapse Incontinence Sexual Questionnaire, IUGA-revised (PISQ-IR) is a questionnaire measuring the impact of incontinence symptoms on sexual function and satisfaction. Using the Rockwood scoring, the PISQ-IR Not Sexually Active-Condition Specific subscale (NSA-CS) ranges from 0 to 100 with worse scores indicating better function/satisfaction. The change from baseline outcome is calculated as the difference in score at 3, 6, or 12 months and the score at baseline.

Outcome measures

Outcome measures
Measure	MUS Only n=229 Participants Midurethral sling alone	MUS+BPTx n=235 Participants Midurethral sling and behavioral/pelvic floor therapy
Change From Baseline PISQ-IR NSACS Score 3 Months	-16.8 units on a scale Interval -26.1 to -7.5	-20.3 units on a scale Interval -27.1 to -13.4
Change From Baseline PISQ-IR NSACS Score 6 Months	-18.9 units on a scale Interval -29.7 to -8.0	-16.4 units on a scale Interval -25.8 to -7.1
Change From Baseline PISQ-IR NSACS Score 12 Months	-13.5 units on a scale Interval -24.7 to -2.3	-9.9 units on a scale Interval -20.9 to 1.2

OTHER_PRE_SPECIFIED outcome

Timeframe: 3, 6, and 12 Months

The Pelvic Organ Prolapse Incontinence Sexual Questionnaire, IUGA-revised (PISQ-IR) is a questionnaire measuring the impact of incontinence symptoms on sexual function and satisfaction. Using the Rockwood scoring, the PISQ-IR Not Sexually Active-Global Quality Rating subscale (NSA-GQR) ranges from 0 to 100 with higher scores indicating worse function/satisfaction. The change from baseline outcome is calculated as the difference in score at 3, 6, or 12 months and the score at baseline.

Outcome measures

Outcome measures
Measure	MUS Only n=229 Participants Midurethral sling alone	MUS+BPTx n=235 Participants Midurethral sling and behavioral/pelvic floor therapy
Change From Baseline PISQ-IR NSAGQR Score 3 Months	-10 units on a scale Interval -16.9 to -3.1	-14.8 units on a scale Interval -22.2 to -7.3
Change From Baseline PISQ-IR NSAGQR Score 6 Months	-9.8 units on a scale Interval -17.8 to -1.9	-15.3 units on a scale Interval -24.9 to -5.8
Change From Baseline PISQ-IR NSAGQR Score 12 Months	-9.1 units on a scale Interval -17.1 to -1.0	-16.5 units on a scale Interval -26.0 to -7.0

OTHER_PRE_SPECIFIED outcome

Timeframe: 3, 6, and 12 Months

The Pelvic Organ Prolapse Incontinence Sexual Questionnaire, IUGA-revised (PISQ-IR) is a questionnaire measuring the impact of incontinence symptoms on sexual function and satisfaction. Using the Rockwood scoring, the PISQ-IR Not Sexually Active-Condition Impact subscale (NSA-CI) ranges from 0 to 100 with higher scores indicating worse function/satisfaction. The change from baseline outcome is calculated as the difference in score at 3, 6, or 12 months and the score at baseline.

Outcome measures

Outcome measures
Measure	MUS Only n=229 Participants Midurethral sling alone	MUS+BPTx n=235 Participants Midurethral sling and behavioral/pelvic floor therapy
Change From Baseline PISQ-IR NSACI Score 3 Months	-25.2 units on a scale Interval -33.6 to -16.8	-27.9 units on a scale Interval -37.8 to -17.9
Change From Baseline PISQ-IR NSACI Score 6 Months	-32.1 units on a scale Interval -40.7 to -23.5	-23.8 units on a scale Interval -35.1 to -12.5
Change From Baseline PISQ-IR NSACI Score 12 Months	-28.8 units on a scale Interval -38.7 to -19.0	-33 units on a scale Interval -44.6 to -21.4

OTHER_PRE_SPECIFIED outcome

Timeframe: 3, 6, and 12 Months

The Pelvic Organ Prolapse Incontinence Sexual Questionnaire, IUGA-revised (PISQ-IR) is a questionnaire measuring the impact of incontinence symptoms on sexual function and satisfaction. Using the Rockwood scoring, the PISQ-IR Sexually Active-Arousal, Orgasm subscale (SA-AO) ranges from 0 to 100 with higher scores indicating worse function/satisfaction. The change from baseline outcome is calculated as the difference in score at 3, 6, or 12 months and the score at baseline.

Outcome measures

Outcome measures
Measure	MUS Only n=229 Participants Midurethral sling alone	MUS+BPTx n=235 Participants Midurethral sling and behavioral/pelvic floor therapy
Change From Baseline PISQ-IR SAAO Score 3 Months	6.8 units on a scale Interval 3.7 to 9.9	10.8 units on a scale Interval 7.8 to 13.8
Change From Baseline PISQ-IR SAAO Score 6 Months	6.5 units on a scale Interval 2.9 to 10.1	12.1 units on a scale Interval 8.9 to 15.3
Change From Baseline PISQ-IR SAAO Score 12 Months	9.2 units on a scale Interval 6.0 to 12.4	9.6 units on a scale Interval 6.6 to 12.6

OTHER_PRE_SPECIFIED outcome

Timeframe: 3, 6, and 12 Months

The Pelvic Organ Prolapse Incontinence Sexual Questionnaire, IUGA-revised (PISQ-IR) is a questionnaire measuring the impact of incontinence symptoms on sexual function and satisfaction. Using the Rockwood scoring, the PISQ-IR Sexually Active-Partner Related subscale (SA-PR) ranges from 0 to 100 with higher scores indicating better function/satisfaction. The change from baseline outcome is calculated as the difference in score at 3, 6, or 12 months and the score at baseline.

Outcome measures

Outcome measures
Measure	MUS Only n=229 Participants Midurethral sling alone	MUS+BPTx n=235 Participants Midurethral sling and behavioral/pelvic floor therapy
Change From Baseline PISQ-IR SAPR Score 3 Months	5.2 units on a scale Interval 1.8 to 8.5	7 units on a scale Interval 3.1 to 11.0
Change From Baseline PISQ-IR SAPR Score 6 Months	4.9 units on a scale Interval 1.2 to 8.5	6.3 units on a scale Interval 2.1 to 10.6
Change From Baseline PISQ-IR SAPR Score 12 Months	2.3 units on a scale Interval -1.7 to 6.3	4.6 units on a scale Interval -0.3 to 9.5

OTHER_PRE_SPECIFIED outcome

Timeframe: 3, 6, and 12 Months

The Pelvic Organ Prolapse Incontinence Sexual Questionnaire, IUGA-revised (PISQ-IR) is a questionnaire measuring the impact of incontinence symptoms on sexual function and satisfaction. Using the Rockwood scoring, the PISQ-IR Sexually Active-Condition Specific subscale (SA-CS) ranges from 0 to 100 with higher scores indicating better function/satisfaction. The change from baseline outcome is calculated as the difference in score at 3, 6, or 12 months and the score at baseline.

Outcome measures

Outcome measures
Measure	MUS Only n=229 Participants Midurethral sling alone	MUS+BPTx n=235 Participants Midurethral sling and behavioral/pelvic floor therapy
Change From Baseline PISQ-IR SACS Score 3 Months	21.1 units on a scale Interval 16.9 to 25.4	28.2 units on a scale Interval 23.3 to 33.0
Change From Baseline PISQ-IR SACS Score 6 Months	20 units on a scale Interval 15.1 to 24.9	28.9 units on a scale Interval 23.7 to 34.1
Change From Baseline PISQ-IR SACS Score 12 Months	24.2 units on a scale Interval 19.3 to 29.1	26.3 units on a scale Interval 21.6 to 31.0

OTHER_PRE_SPECIFIED outcome

Timeframe: 3, 6, and 12 Months

The Pelvic Organ Prolapse Incontinence Sexual Questionnaire, IUGA-revised (PISQ-IR) is a questionnaire measuring the impact of incontinence symptoms on sexual function and satisfaction. Using the Rockwood scoring, the PISQ-IR Sexually Active-Global Quality Rating subscale (SA-GQR) ranges from 0 to 100 with higher scores indicating better function/satisfaction. The change from baseline outcome is calculated as the difference in score at 3, 6, or 12 months and the score at baseline.

Outcome measures

Outcome measures
Measure	MUS Only n=229 Participants Midurethral sling alone	MUS+BPTx n=235 Participants Midurethral sling and behavioral/pelvic floor therapy
Change From Baseline PISQ-IR SAGQR Score 12 Months	19 units on a scale Interval 13.9 to 24.1	13.5 units on a scale Interval 7.9 to 19.0
Change From Baseline PISQ-IR SAGQR Score 3 Months	13.5 units on a scale Interval 8.4 to 18.6	18.3 units on a scale Interval 13.5 to 23.0
Change From Baseline PISQ-IR SAGQR Score 6 Months	12.1 units on a scale Interval 6.5 to 17.7	19 units on a scale Interval 14.1 to 24.0

OTHER_PRE_SPECIFIED outcome

Timeframe: 3, 6, and 12 Months

The Pelvic Organ Prolapse Incontinence Sexual Questionnaire, IUGA-revised (PISQ-IR) is a questionnaire measuring the impact of incontinence symptoms on sexual function and satisfaction. Using the Rockwood scoring, the PISQ-IR Sexually Active-Condition Impact subscale (SA-CI) ranges from 0 to 100 with higher scores indicating better function/satisfaction. The change from baseline outcome is calculated as the difference in score at 3, 6, or 12 months and the score at baseline.

Outcome measures

Outcome measures
Measure	MUS Only n=229 Participants Midurethral sling alone	MUS+BPTx n=235 Participants Midurethral sling and behavioral/pelvic floor therapy
Change From Baseline PISQ-IR SACI Score 3 Months	28.4 units on a scale Interval 22.5 to 34.3	33.6 units on a scale Interval 27.6 to 39.5
Change From Baseline PISQ-IR SACI Score 6 Months	28.9 units on a scale Interval 22.5 to 35.3	35.3 units on a scale Interval 28.9 to 41.7
Change From Baseline PISQ-IR SACI Score 12 Months	31.7 units on a scale Interval 24.7 to 38.7	35.5 units on a scale Interval 29.4 to 41.7

OTHER_PRE_SPECIFIED outcome

Timeframe: 3, 6, and 12 Months

The Pelvic Organ Prolapse Incontinence Sexual Questionnaire, IUGA-revised (PISQ-IR) is a questionnaire measuring the impact of incontinence symptoms on sexual function and satisfaction. Using the Rockwood scoring, the PISQ-IR Sexually Active-Desire subscale (SA-D) ranges from 0 to 100 with higher scores indicating better function/satisfaction. The change from baseline outcome is calculated as the difference in score at 3, 6, or 12 months and the score at baseline.

Outcome measures

Outcome measures
Measure	MUS Only n=229 Participants Midurethral sling alone	MUS+BPTx n=235 Participants Midurethral sling and behavioral/pelvic floor therapy
Change From Baseline PISQ-IR SAD Score 3 Months	3.8 units on a scale Interval 0.8 to 6.9	7.1 units on a scale Interval 4.4 to 9.7
Change From Baseline PISQ-IR SAD Score 6 Months	0.4 units on a scale Interval -3.1 to 3.8	5.4 units on a scale Interval 2.7 to 8.1
Change From Baseline PISQ-IR SAD Score 12 Months	2.7 units on a scale Interval -0.7 to 6.0	2.5 units on a scale Interval -0.8 to 5.7

OTHER_PRE_SPECIFIED outcome

Timeframe: 3, 6, and 12 Months

EQ-5D is a standardized instrument developed by the EuroQol Group as a measure of health-related quality of life. The index score ranges from 0 to 1 with higher scores indicating a better quality of life. The change from baseline outcome is calculated as the difference in score at 3, 6, or 12 months and the score at baseline.

Outcome measures

Outcome measures
Measure	MUS Only n=229 Participants Midurethral sling alone	MUS+BPTx n=235 Participants Midurethral sling and behavioral/pelvic floor therapy
Change From Baseline EQ-5D Index Score 6 Months	0 units on a scale Interval 0.0 to 0.1	0 units on a scale Interval 0.0 to 0.1
Change From Baseline EQ-5D Index Score 12 Months	0 units on a scale Interval 0.0 to 0.0	0 units on a scale Interval 0.0 to 0.1
Change From Baseline EQ-5D Index Score 3 Months	0 units on a scale Interval 0.0 to 0.1	0 units on a scale Interval 0.0 to 0.1

OTHER_PRE_SPECIFIED outcome

Timeframe: 3, 6, and 12 Months

EQ-5D is a standardized instrument developed by the EuroQol Group as a measure of health-related quality of life. The visual analog scale (VAS) score ranges from 0 to 100 with higher scores indicating a better quality of life. The change from baseline outcome is calculated as the difference in score at 3, 6, or 12 months and the score at baseline.

Outcome measures

Outcome measures
Measure	MUS Only n=229 Participants Midurethral sling alone	MUS+BPTx n=235 Participants Midurethral sling and behavioral/pelvic floor therapy
Change From Baseline EQ-5D Visual Analog Scale Score 3 Months	0.3 units on a scale Interval -2.5 to 3.1	4 units on a scale Interval 1.0 to 7.0
Change From Baseline EQ-5D Visual Analog Scale Score 6 Months	2.5 units on a scale Interval -0.8 to 5.8	3.1 units on a scale Interval -0.5 to 6.7
Change From Baseline EQ-5D Visual Analog Scale Score 12 Months	1.2 units on a scale Interval -1.8 to 4.2	4.8 units on a scale Interval 1.6 to 7.9

OTHER_PRE_SPECIFIED outcome

Timeframe: 3, 6, and 12 Months

The Overactive Bladder Questionnaire-Long Form is a standardized a measure of overactive bladder symptoms and health-related quality of life. The OABq-LF Symptom Severity score ranges from 0 to 100 with higher score indicating worse quality of life. The change from baseline outcome is calculated as the difference in score at 3, 6, or 12 months and the score at baseline.

Outcome measures

Outcome measures
Measure	MUS Only n=229 Participants Midurethral sling alone	MUS+BPTx n=235 Participants Midurethral sling and behavioral/pelvic floor therapy
Change From Baseline OABq-LF Symptom Severity Score 3 Months	-45.3 units on a scale Interval -48.7 to -41.8	-46.9 units on a scale Interval -50.2 to -43.7
Change From Baseline OABq-LF Symptom Severity Score 6 Months	-45.4 units on a scale Interval -49.2 to -41.6	-47.2 units on a scale Interval -50.8 to -43.6
Change From Baseline OABq-LF Symptom Severity Score 12 Months	-45.7 units on a scale Interval -49.6 to -41.8	-48.5 units on a scale Interval -52.2 to -44.8

OTHER_PRE_SPECIFIED outcome

Timeframe: 3, 6, and 12 Months

The Overactive Bladder Questionnaire-Long Form is a standardized a measure of overactive bladder symptoms and health-related quality of life. The OABq-LF Coping score ranges from 0 to 100 with higher score indicating better quality of life. The change from baseline outcome is calculated as the difference in score at 3, 6, or 12 months and the score at baseline.

Outcome measures

Outcome measures
Measure	MUS Only n=229 Participants Midurethral sling alone	MUS+BPTx n=235 Participants Midurethral sling and behavioral/pelvic floor therapy
Change From Baseline OABq-LF Coping Score 3 Months	43.1 units on a scale Interval 39.1 to 47.1	48.2 units on a scale Interval 44.4 to 52.0
Change From Baseline OABq-LF Coping Score 6 Months	43.3 units on a scale Interval 38.9 to 47.6	48.4 units on a scale Interval 44.6 to 52.2
Change From Baseline OABq-LF Coping Score 12 Months	43.9 units on a scale Interval 39.6 to 48.2	47.9 units on a scale Interval 43.9 to 52.0

OTHER_PRE_SPECIFIED outcome

Timeframe: 3, 6, and 12 Months

The Overactive Bladder Questionnaire-Long Form is a standardized a measure of overactive bladder symptoms and health-related quality of life. The OABq-LF Concern score ranges from 0 to 100 with higher score indicating better quality of life. The change from baseline outcome is calculated as the difference in score at 3, 6, or 12 months and the score at baseline.

Outcome measures

Outcome measures
Measure	MUS Only n=229 Participants Midurethral sling alone	MUS+BPTx n=235 Participants Midurethral sling and behavioral/pelvic floor therapy
Change From Baseline OABq-LF Concern Score 3 Months	47.6 units on a scale Interval 43.8 to 51.4	51.2 units on a scale Interval 47.2 to 55.1
Change From Baseline OABq-LF Concern Score 6 Months	47 units on a scale Interval 42.8 to 51.1	51.1 units on a scale Interval 47.3 to 54.9
Change From Baseline OABq-LF Concern Score 12 Months	46.9 units on a scale Interval 42.6 to 51.2	50.4 units on a scale Interval 46.4 to 54.5

OTHER_PRE_SPECIFIED outcome

Timeframe: 3, 6, and 12 Months

The Overactive Bladder Questionnaire-Long Form is a standardized a measure of overactive bladder symptoms and health-related quality of life. The OABq-LF Sleep score ranges from 0 to 100 with higher score indicating better quality of life. The change from baseline outcome is calculated as the difference in score at 3, 6, or 12 months and the score at baseline.

Outcome measures

Outcome measures
Measure	MUS Only n=229 Participants Midurethral sling alone	MUS+BPTx n=235 Participants Midurethral sling and behavioral/pelvic floor therapy
Change From Baseline OABq-LF Sleep Score 3 Months	31.7 units on a scale Interval 27.8 to 35.6	31.6 units on a scale Interval 27.4 to 35.8
Change From Baseline OABq-LF Sleep Score 6 Months	31.3 units on a scale Interval 27.2 to 35.3	31.9 units on a scale Interval 27.5 to 36.3
Change From Baseline OABq-LF Sleep Score 12 Months	31.8 units on a scale Interval 27.5 to 36.2	32.7 units on a scale Interval 28.1 to 37.3

OTHER_PRE_SPECIFIED outcome

Timeframe: 3, 6, and 12 Months

The Overactive Bladder Questionnaire-Long Form is a standardized a measure of overactive bladder symptoms and health-related quality of life. The OABq-LF Social score ranges from 0 to 100 with higher score indicating better quality of life. The change from baseline outcome is calculated as the difference in score at 3, 6, or 12 months and the score at baseline.

Outcome measures

Outcome measures
Measure	MUS Only n=229 Participants Midurethral sling alone	MUS+BPTx n=235 Participants Midurethral sling and behavioral/pelvic floor therapy
Change From Baseline OABq-LF Social Score 3 Months	25.6 units on a scale Interval 21.8 to 29.4	26.5 units on a scale Interval 22.7 to 30.4
Change From Baseline OABq-LF Social Score 6 Months	23.5 units on a scale Interval 19.4 to 27.6	26.1 units on a scale Interval 22.2 to 30.0
Change From Baseline OABq-LF Social Score 12 Months	24.1 units on a scale Interval 19.9 to 28.3	25.8 units on a scale Interval 21.8 to 29.9

OTHER_PRE_SPECIFIED outcome

Timeframe: 3, 6, and 12 Months

The Overactive Bladder Questionnaire-Long Form is a standardized a measure of overactive bladder symptoms and health-related quality of life. The OABq-LF HRQL score ranges from 0 to 100 with higher score indicating better quality of life. The change from baseline outcome is calculated as the difference in score at 3, 6, or 12 months and the score at baseline.

Outcome measures

Outcome measures
Measure	MUS Only n=229 Participants Midurethral sling alone	MUS+BPTx n=235 Participants Midurethral sling and behavioral/pelvic floor therapy
Change From Baseline OABq-LF HRQL Total Score 3 Months	38.6 units on a scale Interval 35.1 to 42.0	41.4 units on a scale Interval 37.9 to 44.8
Change From Baseline OABq-LF HRQL Total Score 6 Months	38 units on a scale Interval 34.3 to 41.8	41.4 units on a scale Interval 38.0 to 44.8
Change From Baseline OABq-LF HRQL Total Score 12 Months	38.6 units on a scale Interval 34.8 to 42.4	41.1 units on a scale Interval 37.4 to 44.8

OTHER_PRE_SPECIFIED outcome

Timeframe: 3, 6, and 12 Months

The Overactive Bladder Satisfaction with Treatment Questionnaire is a standardized a measure of satisfaction with treatment for overactive bladder symptoms. The OAB-SATq Satisfaction score ranges from 0 to 100 with higher scores indicating higher satisfaction.

Outcome measures

Outcome measures
Measure	MUS Only n=229 Participants Midurethral sling alone	MUS+BPTx n=235 Participants Midurethral sling and behavioral/pelvic floor therapy
OAB-SATq Satisfaction Score 3 Months	19.3 units on a scale Interval 16.0 to 22.7	18.2 units on a scale Interval 15.2 to 21.3
OAB-SATq Satisfaction Score 6 Months	19.8 units on a scale Interval 15.7 to 23.9	18.7 units on a scale Interval 15.3 to 22.2
OAB-SATq Satisfaction Score 12 Months	18.1 units on a scale Interval 14.2 to 22.1	17.3 units on a scale Interval 14.0 to 20.6

OTHER_PRE_SPECIFIED outcome

Timeframe: 3, 6, and 12 Months

The Overactive Bladder Satisfaction with Treatment Questionnaire is a standardized a measure of satisfaction with treatment for overactive bladder symptoms. The OAB-SATq Side Effect score ranges from 0 to 100 with higher scores indicating fewer side effects.

Outcome measures

Outcome measures
Measure	MUS Only n=229 Participants Midurethral sling alone	MUS+BPTx n=235 Participants Midurethral sling and behavioral/pelvic floor therapy
OAB-SATq Side Effect Score 3 Months	76 units on a scale Interval 70.6 to 81.3	84.3 units on a scale Interval 79.6 to 89.0
OAB-SATq Side Effect Score 6 Months	79.7 units on a scale Interval 74.3 to 85.1	87.2 units on a scale Interval 82.9 to 91.6
OAB-SATq Side Effect Score 12 Months	81 units on a scale Interval 75.7 to 86.4	86.3 units on a scale Interval 81.7 to 90.8

OTHER_PRE_SPECIFIED outcome

Timeframe: 3, 6, and 12 Months

The Overactive Bladder Satisfaction with Treatment Questionnaire is a standardized a measure of satisfaction with treatment for overactive bladder symptoms. The OAB-SATq Endorsement score ranges from 0 to 100 with higher scores indicating greater endorsement.

Outcome measures

Outcome measures
Measure	MUS Only n=229 Participants Midurethral sling alone	MUS+BPTx n=235 Participants Midurethral sling and behavioral/pelvic floor therapy
OAB-SATq Endorsement Score 3 Months	10.6 units on a scale Interval 8.1 to 13.0	8.8 units on a scale Interval 6.5 to 11.0
OAB-SATq Endorsement Score 6 Months	11.2 units on a scale Interval 8.0 to 14.5	6.6 units on a scale Interval 4.5 to 8.7
OAB-SATq Endorsement Score 12 Months	10.7 units on a scale Interval 7.3 to 14.0	8.9 units on a scale Interval 6.5 to 11.4

OTHER_PRE_SPECIFIED outcome

Timeframe: 3, 6, and 12 Months

The Overactive Bladder Satisfaction with Treatment Questionnaire is a standardized a measure of satisfaction with treatment for overactive bladder symptoms. The OAB-SATq Convenience score ranges from 0 to 100 with higher scores indicating greater convenience.

Outcome measures

Outcome measures
Measure	MUS Only n=229 Participants Midurethral sling alone	MUS+BPTx n=235 Participants Midurethral sling and behavioral/pelvic floor therapy
OAB-SATq Convenience Score 3 Months	18.8 units on a scale Interval 15.8 to 21.8	25.8 units on a scale Interval 22.8 to 28.9
OAB-SATq Convenience Score 6 Months	19.1 units on a scale Interval 15.6 to 22.6	26.2 units on a scale Interval 22.8 to 29.6
OAB-SATq Convenience Score 12 Months	19.7 units on a scale Interval 16.0 to 23.3	21.3 units on a scale Interval 18.1 to 24.6

OTHER_PRE_SPECIFIED outcome

Timeframe: 3, 6, and 12 Months

The Overactive Bladder Satisfaction with Treatment Questionnaire is a standardized a measure of satisfaction with treatment for overactive bladder symptoms. The preference score is a binary \[yes/no\] indicator as to whether a subject indicated slight or definite preference for the treatment among women that have had previous treatment for overactive bladder. The outcome is the percentage of participants that prefer the current treatment to previous treatments.

Outcome measures

Outcome measures
Measure	MUS Only n=229 Participants Midurethral sling alone	MUS+BPTx n=235 Participants Midurethral sling and behavioral/pelvic floor therapy
OAB-SATq Preference Score 3 Months · Yes	111 Participants	109 Participants
OAB-SATq Preference Score 3 Months · No	12 Participants	9 Participants
OAB-SATq Preference Score 6 Months · Yes	101 Participants	112 Participants
OAB-SATq Preference Score 6 Months · No	3 Participants	5 Participants
OAB-SATq Preference Score 12 Months · Yes	98 Participants	107 Participants
OAB-SATq Preference Score 12 Months · No	11 Participants	9 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 3, 6, and 12 Months

The Incontinence Impact Questionnaire-Long Form is a standardized a measure of health-related quality of life. The IIq-LF Physical Activity score ranges from 0 to 100 with higher scores indicating worse impact. The change from baseline outcome is calculated as the difference in score at 3, 6, or 12 months and the score at baseline.

Outcome measures

Outcome measures
Measure	MUS Only n=229 Participants Midurethral sling alone	MUS+BPTx n=235 Participants Midurethral sling and behavioral/pelvic floor therapy
Change From Baseline IIq-LF Physical Activity Score 3 Months	-39.2 units on a scale Interval -43.2 to -35.3	-40.9 units on a scale Interval -44.7 to -37.1
Change From Baseline IIq-LF Physical Activity Score 6 Months	-39.1 units on a scale Interval -43.5 to -34.8	-42.1 units on a scale Interval -46.0 to -38.1
Change From Baseline IIq-LF Physical Activity Score 12 Months	-42.3 units on a scale Interval -46.3 to -38.3	-42.5 units on a scale Interval -46.5 to -38.4

OTHER_PRE_SPECIFIED outcome

Timeframe: 3, 6, and 12 Months

The Incontinence Impact Questionnaire-Long Form is a standardized a measure of health-related quality of life. The IIq-LF Travel score ranges from 0 to 100 with higher scores indicating worse impact. The change from baseline outcome is calculated as the difference in score at 3, 6, or 12 months and the score at baseline.

Outcome measures

Outcome measures
Measure	MUS Only n=229 Participants Midurethral sling alone	MUS+BPTx n=235 Participants Midurethral sling and behavioral/pelvic floor therapy
Change From Baseline IIq-LF Travel Score 3 Months	-33.9 units on a scale Interval -38.1 to -29.8	-38.9 units on a scale Interval -43.1 to -34.8
Change From Baseline IIq-LF Travel Score 6 Months	-33.4 units on a scale Interval -38.0 to -28.8	-40.9 units on a scale Interval -45.3 to -36.5
Change From Baseline IIq-LF Travel Score 12 Months	-35.4 units on a scale Interval -39.9 to -30.9	-40.8 units on a scale Interval -45.1 to -36.4

OTHER_PRE_SPECIFIED outcome

Timeframe: 3, 6, and 12 Months

The Incontinence Impact Questionnaire-Long Form is a standardized a measure of health-related quality of life. The IIq-LF Social Relationship score ranges from 0 to 100 with higher scores indicating worse impact. The change from baseline outcome is calculated as the difference in score at 3, 6, or 12 months and the score at baseline.

Outcome measures

Outcome measures
Measure	MUS Only n=229 Participants Midurethral sling alone	MUS+BPTx n=235 Participants Midurethral sling and behavioral/pelvic floor therapy
Change From Baseline IIq-LF Social Relationship Score 3 Months	-28.9 units on a scale Interval -32.4 to -25.5	-32.8 units on a scale Interval -36.4 to -29.1
Change From Baseline IIq-LF Social Relationship Score 6 Months	-28.6 units on a scale Interval -32.4 to -24.9	-33.7 units on a scale Interval -37.4 to -30.1
Change From Baseline IIq-LF Social Relationship Score 12 Months	-30 units on a scale Interval -33.8 to -26.1	-34.1 units on a scale Interval -37.9 to -30.2

OTHER_PRE_SPECIFIED outcome

Timeframe: 3, 6, and 12 Months

The Incontinence Impact Questionnaire-Long Form is a standardized a measure of health-related quality of life. The IIq-LF Emotional Health score ranges from 0 to 100 with higher scores indicating worse impact. The change from baseline outcome is calculated as the difference in score at 3, 6, or 12 months and the score at baseline.

Outcome measures

Outcome measures
Measure	MUS Only n=229 Participants Midurethral sling alone	MUS+BPTx n=235 Participants Midurethral sling and behavioral/pelvic floor therapy
Change From Baseline IIq-LF Emotional Health Score 3 Months	-38.4 units on a scale Interval -42.2 to -34.5	-40.7 units on a scale Interval -44.5 to -36.9
Change From Baseline IIq-LF Emotional Health Score 6 Months	-38.6 units on a scale Interval -42.6 to -34.5	-41.5 units on a scale Interval -45.2 to -37.8
Change From Baseline IIq-LF Emotional Health Score 12 Months	-38.3 units on a scale Interval -42.4 to -34.3	-42.8 units on a scale Interval -46.7 to -39.0

OTHER_PRE_SPECIFIED outcome

Timeframe: 3, 6, and 12 Months

The Incontinence Impact Questionnaire-Long Form is a standardized a measure of health-related quality of life. The IIq-LF Total score ranges from 0 to 400 with higher scores indicating worse impact. The change from baseline outcome is calculated as the difference in score at 3, 6, or 12 months and the score at baseline.

Outcome measures

Outcome measures
Measure	MUS Only n=229 Participants Midurethral sling alone	MUS+BPTx n=235 Participants Midurethral sling and behavioral/pelvic floor therapy
Change From Baseline IIq-LF Total Score 3 Months	-140.4 units on a scale Interval -154.2 to -126.7	-153.3 units on a scale Interval -167.3 to -139.3
Change From Baseline IIq-LF Total Score 6 Months	-139.8 units on a scale Interval -154.9 to -124.6	-158.2 units on a scale Interval -172.3 to -144.1
Change From Baseline IIq-LF Total Score 12 Months	-146 units on a scale Interval -160.8 to -131.2	-160.1 units on a scale Interval -174.5 to -145.8

OTHER_PRE_SPECIFIED outcome

Timeframe: 3, 6, and 12 Months

The Adaptation Index is a standardized measure of health-related quality of life. The ADI Hygiene score ranges from 0 to 100 with higher score indicating worse severity in adaptive behaviors. The change from baseline outcome is calculated as the difference in score at 3, 6, or 12 months and the score at baseline.

Outcome measures

Outcome measures
Measure	MUS Only n=229 Participants Midurethral sling alone	MUS+BPTx n=235 Participants Midurethral sling and behavioral/pelvic floor therapy
Change From Baseline ADI Hygiene Score 12 Months	-35.5 units on a scale Interval -39.2 to -31.8	-38.8 units on a scale Interval -42.3 to -35.4
Change From Baseline ADI Hygiene Score 3 Months	-32.1 units on a scale Interval -35.5 to -28.8	-36.7 units on a scale Interval -40.0 to -33.3
Change From Baseline ADI Hygiene Score 6 Months	-34.6 units on a scale Interval -38.2 to -30.9	-37.6 units on a scale Interval -41.0 to -34.3

OTHER_PRE_SPECIFIED outcome

Timeframe: 3, 6, and 12 Months

The Adaptation Index is a standardized measure of health-related quality of life. The ADI Avoidance score ranges from 0 to 100 with higher score indicating worse severity in adaptive behaviors. The change from baseline outcome is calculated as the difference in score at 3, 6, or 12 months and the score at baseline.

Outcome measures

Outcome measures
Measure	MUS Only n=229 Participants Midurethral sling alone	MUS+BPTx n=235 Participants Midurethral sling and behavioral/pelvic floor therapy
Change From Baseline ADI Avoidance Score 3 Months	-31.3 units on a scale Interval -34.7 to -27.8	-33.8 units on a scale Interval -37.1 to -30.6
Change From Baseline ADI Avoidance Score 6 Months	-32.5 units on a scale Interval -36.1 to -28.8	-34.5 units on a scale Interval -38.0 to -30.9
Change From Baseline ADI Avoidance Score 12 Months	-33 units on a scale Interval -36.8 to -29.2	-35.7 units on a scale Interval -39.2 to -32.2

OTHER_PRE_SPECIFIED outcome

Timeframe: 2 weeks and 2 and 12 Months

The Brink scale considers three pelvic floor muscle contraction variables: vaginal pressure or muscle force, elevation or vertical displacement of the examiner fingers, and duration of contraction. The score ranges from 3 to 12 with higher scores indicating greater PFM function. The change from baseline outcome is calculated as the difference in score at 3 or 12 months and the score at baseline.

Outcome measures

Outcome measures
Measure	MUS Only n=229 Participants Midurethral sling alone	MUS+BPTx n=235 Participants Midurethral sling and behavioral/pelvic floor therapy
Change From Baseline Brink Score 0.5 Months	0.5 units on a scale Interval 0.2 to 0.8	0.2 units on a scale Interval -0.1 to 0.6
Change From Baseline Brink Score 2 Months	0.5 units on a scale Interval 0.2 to 0.8	0.6 units on a scale Interval 0.3 to 0.9
Change From Baseline Brink Score 12 Months	0.6 units on a scale Interval 0.2 to 1.0	0.6 units on a scale Interval 0.3 to 1.0

OTHER_PRE_SPECIFIED outcome

Timeframe: 2 weeks and 2 and 12 Months

The average peak muscle contraction is measured during a physical exam. The outcome is calculated as the difference in measured value at 3 or 12 months and the score at baseline.

Outcome measures

Outcome measures
Measure	MUS Only n=229 Participants Midurethral sling alone	MUS+BPTx n=235 Participants Midurethral sling and behavioral/pelvic floor therapy
Change From Average Peak Muscle Contraction Pressure (cm H2O) 0.5 Months	3.7 cm H2O Interval 1.8 to 5.6	0.7 cm H2O Interval -1.3 to 2.7
Change From Average Peak Muscle Contraction Pressure (cm H2O) 2 Months	5 cm H2O Interval 2.6 to 7.4	4.6 cm H2O Interval 1.9 to 7.3
Change From Average Peak Muscle Contraction Pressure (cm H2O) 12 Months	4 cm H2O Interval 1.9 to 6.2	4.4 cm H2O Interval 1.5 to 7.2

OTHER_PRE_SPECIFIED outcome

Timeframe: 3, 6, and 12 Months

The Patient Global Impression of Improvement (PGI-I) is a patient-reported measure of perceived improvement with treatment, as assessed on a scale of 1 (very much better) to 7 (very much worse). Included here are participants who had improvement as indicated by a rating of 1 (very much better), 2 (much better).

Outcome measures

Outcome measures
Measure	MUS Only n=229 Participants Midurethral sling alone	MUS+BPTx n=235 Participants Midurethral sling and behavioral/pelvic floor therapy
PGI-I 3 Months · Improved	179 Participants	178 Participants
PGI-I 3 Months · No Improvement/Worsened	18 Participants	19 Participants
PGI-I 6 Months · Improved	156 Participants	168 Participants
PGI-I 6 Months · No Improvement/Worsened	19 Participants	13 Participants
PGI-I 12 Months · Improved	147 Participants	159 Participants
PGI-I 12 Months · No Improvement/Worsened	27 Participants	22 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline 3, 6, and 12 Months

The Patient Global Impression of Severity (PGI-S) is a patient-reported measure of perceived severity of condition, as assessed on a scale of 1 (Normal) to 4 (Severe). Included here are participants who reported Normal or Mild severity as indicated by a rating of 1 or 2.

Outcome measures

Outcome measures
Measure	MUS Only n=229 Participants Midurethral sling alone	MUS+BPTx n=235 Participants Midurethral sling and behavioral/pelvic floor therapy
PGI-S 3 Months · Moderate/Severe	26 Participants	24 Participants
PGI-S 0 Months · Normal/Mild	41 Participants	48 Participants
PGI-S 0 Months · Moderate/Severe	188 Participants	187 Participants
PGI-S 3 Months · Normal/Mild	171 Participants	174 Participants
PGI-S 6 Months · Normal/Mild	155 Participants	166 Participants
PGI-S 6 Months · Moderate/Severe	21 Participants	16 Participants
PGI-S 12 Months · Normal/Mild	155 Participants	164 Participants
PGI-S 12 Months · Moderate/Severe	19 Participants	16 Participants

Adverse Events

MUS Only

Serious events: 28 serious events

Other events: 163 other events

Deaths: 0 deaths

MUS+BPTx

Serious events: 21 serious events

Other events: 172 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	MUS Only n=238 participants at risk Midurethral sling alone	MUS+BPTx n=242 participants at risk Midurethral sling and behavioral/pelvic floor therapy
Cardiac disorders Acute myocardial infarction	0.42% 1/238 • Number of events 1 • 12 Months	0.00% 0/242 • 12 Months
Cardiac disorders Angina unstable	0.42% 1/238 • Number of events 1 • 12 Months	0.00% 0/242 • 12 Months
Cardiac disorders Atrial fibrillation	0.42% 1/238 • Number of events 1 • 12 Months	0.00% 0/242 • 12 Months
Cardiac disorders Atrial flutter	0.00% 0/238 • 12 Months	0.41% 1/242 • Number of events 1 • 12 Months
Cardiac disorders Palpitations	0.00% 0/238 • 12 Months	0.41% 1/242 • Number of events 1 • 12 Months
Cardiac disorders Pericardial effusion	0.00% 0/238 • 12 Months	0.41% 1/242 • Number of events 1 • 12 Months
Gastrointestinal disorders Gastritis	0.84% 2/238 • Number of events 2 • 12 Months	0.00% 0/242 • 12 Months
Gastrointestinal disorders Large intestinal obstruction	0.42% 1/238 • Number of events 1 • 12 Months	0.00% 0/242 • 12 Months
Gastrointestinal disorders Pancreatitis acute	1.3% 3/238 • Number of events 3 • 12 Months	0.00% 0/242 • 12 Months
Gastrointestinal disorders Umbilical hernia	0.00% 0/238 • 12 Months	0.41% 1/242 • Number of events 1 • 12 Months
Gastrointestinal disorders Vomiting	0.00% 0/238 • 12 Months	0.41% 1/242 • Number of events 1 • 12 Months
General disorders Chest pain	0.42% 1/238 • Number of events 1 • 12 Months	0.41% 1/242 • Number of events 1 • 12 Months
General disorders Non-cardiac chest pain	0.42% 1/238 • Number of events 1 • 12 Months	0.00% 0/242 • 12 Months
Hepatobiliary disorders Bile duct stone	0.42% 1/238 • Number of events 1 • 12 Months	0.00% 0/242 • 12 Months
Hepatobiliary disorders Biliary colic	0.00% 0/238 • 12 Months	0.41% 1/242 • Number of events 1 • 12 Months
Infections and infestations Appendicitis	0.42% 1/238 • Number of events 1 • 12 Months	0.00% 0/242 • 12 Months
Infections and infestations Atypical pneumonia	0.00% 0/238 • 12 Months	0.41% 1/242 • Number of events 1 • 12 Months
Infections and infestations Cellulitis	0.00% 0/238 • 12 Months	0.83% 2/242 • Number of events 2 • 12 Months
Infections and infestations Diverticulitis	0.42% 1/238 • Number of events 1 • 12 Months	0.00% 0/242 • 12 Months
Infections and infestations Gastroenteritis	0.42% 1/238 • Number of events 1 • 12 Months	0.41% 1/242 • Number of events 1 • 12 Months
Infections and infestations Pneumonia	0.00% 0/238 • 12 Months	0.41% 1/242 • Number of events 1 • 12 Months
Infections and infestations Pyelonephritis	0.84% 2/238 • Number of events 2 • 12 Months	0.41% 1/242 • Number of events 1 • 12 Months
Infections and infestations Urinary tract infection	0.42% 1/238 • Number of events 1 • 12 Months	0.00% 0/242 • 12 Months
Infections and infestations Wound infection	0.42% 1/238 • Number of events 1 • 12 Months	0.00% 0/242 • 12 Months
Injury, poisoning and procedural complications Procedural nausea	0.00% 0/238 • 12 Months	0.41% 1/242 • Number of events 1 • 12 Months
Injury, poisoning and procedural complications Procedural vomiting	0.00% 0/238 • 12 Months	0.41% 1/242 • Number of events 1 • 12 Months
Musculoskeletal and connective tissue disorders Intervertebral disc protrusion	0.00% 0/238 • 12 Months	0.41% 1/242 • Number of events 1 • 12 Months
Musculoskeletal and connective tissue disorders Osteoarthritis	0.00% 0/238 • 12 Months	0.41% 1/242 • Number of events 1 • 12 Months
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon cancer stage IV	0.42% 1/238 • Number of events 1 • 12 Months	0.00% 0/242 • 12 Months
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant melanoma	0.42% 1/238 • Number of events 1 • 12 Months	0.00% 0/242 • 12 Months
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Uterine leiomyoma	0.42% 1/238 • Number of events 1 • 12 Months	0.00% 0/242 • 12 Months
Nervous system disorders Central nervous system lesion	0.00% 0/238 • 12 Months	0.41% 1/242 • Number of events 1 • 12 Months
Nervous system disorders Cerebrovascular accident	0.42% 1/238 • Number of events 1 • 12 Months	0.00% 0/242 • 12 Months
Nervous system disorders Loss of consciousness	0.00% 0/238 • 12 Months	0.41% 1/242 • Number of events 1 • 12 Months
Nervous system disorders Multiple sclerosis	0.42% 1/238 • Number of events 1 • 12 Months	0.00% 0/242 • 12 Months
Nervous system disorders Somnolence	0.00% 0/238 • 12 Months	0.41% 1/242 • Number of events 1 • 12 Months
Nervous system disorders Spondylitic myelopathy	0.42% 1/238 • Number of events 1 • 12 Months	0.00% 0/242 • 12 Months
Nervous system disorders Syncope	0.42% 1/238 • Number of events 1 • 12 Months	0.00% 0/242 • 12 Months
Psychiatric disorders Anxiety	0.42% 1/238 • Number of events 1 • 12 Months	0.00% 0/242 • 12 Months
Psychiatric disorders Mental status changes	0.00% 0/238 • 12 Months	0.41% 1/242 • Number of events 1 • 12 Months
Renal and urinary disorders Chronic kidney disease	0.42% 1/238 • Number of events 1 • 12 Months	0.00% 0/242 • 12 Months
Renal and urinary disorders Prerenal failure	0.42% 1/238 • Number of events 1 • 12 Months	0.00% 0/242 • 12 Months
Renal and urinary disorders Urinary retention	0.42% 1/238 • Number of events 1 • 12 Months	0.00% 0/242 • 12 Months
Respiratory, thoracic and mediastinal disorders Asthma	0.00% 0/238 • 12 Months	0.83% 2/242 • Number of events 3 • 12 Months
Respiratory, thoracic and mediastinal disorders Hypoxia	0.42% 1/238 • Number of events 1 • 12 Months	0.00% 0/242 • 12 Months
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.00% 0/238 • 12 Months	0.41% 1/242 • Number of events 1 • 12 Months
Respiratory, thoracic and mediastinal disorders Pulmonary sarcoidosis	0.00% 0/238 • 12 Months	0.41% 1/242 • Number of events 1 • 12 Months
Surgical and medical procedures Bladder neck suspension	0.84% 2/238 • Number of events 2 • 12 Months	0.00% 0/242 • 12 Months
Surgical and medical procedures Gastrectomy	0.00% 0/238 • 12 Months	0.41% 1/242 • Number of events 1 • 12 Months
Surgical and medical procedures Gastric bypass	0.42% 1/238 • Number of events 1 • 12 Months	0.00% 0/242 • 12 Months
Surgical and medical procedures High frequency ablation	0.00% 0/238 • 12 Months	0.41% 1/242 • Number of events 1 • 12 Months
Surgical and medical procedures Inguinal hernia repair	0.00% 0/238 • 12 Months	0.41% 1/242 • Number of events 1 • 12 Months
Surgical and medical procedures Tendon operation	0.42% 1/238 • Number of events 1 • 12 Months	0.00% 0/242 • 12 Months
Vascular disorders Haematoma	0.42% 1/238 • Number of events 1 • 12 Months	0.00% 0/242 • 12 Months

Other adverse events

Other adverse events
Measure	MUS Only n=238 participants at risk Midurethral sling alone	MUS+BPTx n=242 participants at risk Midurethral sling and behavioral/pelvic floor therapy
Blood and lymphatic system disorders Anaemia	1.3% 3/238 • Number of events 3 • 12 Months	0.83% 2/242 • Number of events 2 • 12 Months
Cardiac disorders Arrhythmia supraventricular	0.00% 0/238 • 12 Months	0.41% 1/242 • Number of events 1 • 12 Months
Cardiac disorders Atrial fibrillation	0.84% 2/238 • Number of events 2 • 12 Months	0.00% 0/242 • 12 Months
Cardiac disorders Palpitations	0.42% 1/238 • Number of events 1 • 12 Months	0.83% 2/242 • Number of events 2 • 12 Months
Cardiac disorders Sinus tachycardia	0.42% 1/238 • Number of events 1 • 12 Months	0.00% 0/242 • 12 Months
Congenital, familial and genetic disorders Argininosuccinate lyase deficiency	0.42% 1/238 • Number of events 1 • 12 Months	0.00% 0/242 • 12 Months
Ear and labyrinth disorders Ear pain	1.3% 3/238 • Number of events 3 • 12 Months	0.41% 1/242 • Number of events 1 • 12 Months
Ear and labyrinth disorders Eustachian tube dysfunction	0.00% 0/238 • 12 Months	0.41% 1/242 • Number of events 1 • 12 Months
Ear and labyrinth disorders Tinnitus	0.84% 2/238 • Number of events 2 • 12 Months	0.00% 0/242 • 12 Months
Ear and labyrinth disorders Vertigo	0.84% 2/238 • Number of events 2 • 12 Months	0.00% 0/242 • 12 Months
Ear and labyrinth disorders Vertigo positional	0.00% 0/238 • 12 Months	0.41% 1/242 • Number of events 1 • 12 Months
Endocrine disorders Hypothyroidism	0.42% 1/238 • Number of events 1 • 12 Months	0.00% 0/242 • 12 Months
Eye disorders Blepharitis	0.84% 2/238 • Number of events 2 • 12 Months	0.00% 0/242 • 12 Months
Eye disorders Blepharochalasis	0.00% 0/238 • 12 Months	0.41% 1/242 • Number of events 1 • 12 Months
Eye disorders Conjunctival haemorrhage	0.42% 1/238 • Number of events 1 • 12 Months	0.00% 0/242 • 12 Months
Eye disorders Conjunctivitis allergic	0.00% 0/238 • 12 Months	0.41% 1/242 • Number of events 1 • 12 Months
Eye disorders Dry eye	0.84% 2/238 • Number of events 2 • 12 Months	0.41% 1/242 • Number of events 1 • 12 Months
Eye disorders Eyelid ptosis	0.00% 0/238 • 12 Months	0.41% 1/242 • Number of events 1 • 12 Months
Eye disorders Glaucoma	0.00% 0/238 • 12 Months	0.41% 1/242 • Number of events 1 • 12 Months
Eye disorders Periorbital oedema	0.00% 0/238 • 12 Months	0.41% 1/242 • Number of events 1 • 12 Months
Eye disorders Pinguecula	0.00% 0/238 • 12 Months	0.41% 1/242 • Number of events 1 • 12 Months
Eye disorders Pterygium	0.00% 0/238 • 12 Months	0.41% 1/242 • Number of events 1 • 12 Months
Eye disorders Retinal detachment	0.00% 0/238 • 12 Months	0.41% 1/242 • Number of events 1 • 12 Months
Eye disorders Vision blurred	0.42% 1/238 • Number of events 1 • 12 Months	0.00% 0/242 • 12 Months
Gastrointestinal disorders Abdominal distension	0.84% 2/238 • Number of events 2 • 12 Months	0.00% 0/242 • 12 Months
Gastrointestinal disorders Abdominal pain	4.6% 11/238 • Number of events 13 • 12 Months	4.5% 11/242 • Number of events 13 • 12 Months
Gastrointestinal disorders Abdominal pain lower	2.1% 5/238 • Number of events 5 • 12 Months	1.7% 4/242 • Number of events 4 • 12 Months
Gastrointestinal disorders Abdominal pain upper	1.3% 3/238 • Number of events 3 • 12 Months	0.83% 2/242 • Number of events 2 • 12 Months
Gastrointestinal disorders Cheilitis	0.00% 0/238 • 12 Months	0.41% 1/242 • Number of events 1 • 12 Months
Gastrointestinal disorders Colitis microscopic	0.42% 1/238 • Number of events 1 • 12 Months	0.00% 0/242 • 12 Months
Gastrointestinal disorders Constipation	3.8% 9/238 • Number of events 9 • 12 Months	5.8% 14/242 • Number of events 16 • 12 Months
Gastrointestinal disorders Diarrhoea	2.5% 6/238 • Number of events 6 • 12 Months	2.9% 7/242 • Number of events 7 • 12 Months
Gastrointestinal disorders Diverticulum intestinal	0.00% 0/238 • 12 Months	0.41% 1/242 • Number of events 1 • 12 Months
Gastrointestinal disorders Dyspepsia	0.42% 1/238 • Number of events 1 • 12 Months	1.7% 4/242 • Number of events 4 • 12 Months
Gastrointestinal disorders Faecal incontinence	0.42% 1/238 • Number of events 1 • 12 Months	0.83% 2/242 • Number of events 2 • 12 Months
Gastrointestinal disorders Functional gastrointestinal disorder	0.42% 1/238 • Number of events 1 • 12 Months	0.00% 0/242 • 12 Months
Gastrointestinal disorders Gastritis	0.00% 0/238 • 12 Months	0.41% 1/242 • Number of events 1 • 12 Months
Gastrointestinal disorders Gastrooesophageal reflux disease	0.84% 2/238 • Number of events 2 • 12 Months	0.41% 1/242 • Number of events 1 • 12 Months
Gastrointestinal disorders Gingival swelling	0.42% 1/238 • Number of events 1 • 12 Months	0.00% 0/242 • 12 Months
Gastrointestinal disorders Haemorrhoids	1.7% 4/238 • Number of events 4 • 12 Months	0.41% 1/242 • Number of events 1 • 12 Months
Gastrointestinal disorders Irritable bowel syndrome	0.84% 2/238 • Number of events 2 • 12 Months	0.41% 1/242 • Number of events 1 • 12 Months
Gastrointestinal disorders Levator syndrome	0.84% 2/238 • Number of events 2 • 12 Months	1.2% 3/242 • Number of events 3 • 12 Months
Gastrointestinal disorders Nausea	3.4% 8/238 • Number of events 8 • 12 Months	1.7% 4/242 • Number of events 5 • 12 Months
Gastrointestinal disorders Proctalgia	0.00% 0/238 • 12 Months	0.41% 1/242 • Number of events 1 • 12 Months
Gastrointestinal disorders Rectal haemorrhage	0.00% 0/238 • 12 Months	0.41% 1/242 • Number of events 1 • 12 Months
Gastrointestinal disorders Retroperitoneal haematoma	0.00% 0/238 • 12 Months	0.41% 1/242 • Number of events 1 • 12 Months
Gastrointestinal disorders Stomatitis	0.00% 0/238 • 12 Months	0.41% 1/242 • Number of events 1 • 12 Months
Gastrointestinal disorders Toothache	0.00% 0/238 • 12 Months	0.41% 1/242 • Number of events 1 • 12 Months
Gastrointestinal disorders Vomiting	1.7% 4/238 • Number of events 5 • 12 Months	0.83% 2/242 • Number of events 2 • 12 Months
General disorders Adverse drug reaction	0.00% 0/238 • 12 Months	0.41% 1/242 • Number of events 1 • 12 Months
General disorders Asthenia	0.42% 1/238 • Number of events 1 • 12 Months	0.00% 0/242 • 12 Months
General disorders Catheter site pain	0.00% 0/238 • 12 Months	0.41% 1/242 • Number of events 1 • 12 Months
General disorders Chest discomfort	0.84% 2/238 • Number of events 2 • 12 Months	0.00% 0/242 • 12 Months
General disorders Chest pain	2.1% 5/238 • Number of events 5 • 12 Months	1.7% 4/242 • Number of events 4 • 12 Months
General disorders Chills	0.42% 1/238 • Number of events 1 • 12 Months	0.00% 0/242 • 12 Months
General disorders Discomfort	0.00% 0/238 • 12 Months	0.41% 1/242 • Number of events 1 • 12 Months
General disorders Facial pain	0.00% 0/238 • 12 Months	0.41% 1/242 • Number of events 1 • 12 Months
General disorders Fatigue	0.00% 0/238 • 12 Months	0.83% 2/242 • Number of events 2 • 12 Months
General disorders Hernia pain	0.42% 1/238 • Number of events 1 • 12 Months	0.00% 0/242 • 12 Months
General disorders Inflammation	0.42% 1/238 • Number of events 1 • 12 Months	0.00% 0/242 • 12 Months
General disorders Local swelling	0.84% 2/238 • Number of events 2 • 12 Months	0.00% 0/242 • 12 Months
General disorders Malaise	0.42% 1/238 • Number of events 1 • 12 Months	0.00% 0/242 • 12 Months
General disorders Medical device site reaction	0.84% 2/238 • Number of events 2 • 12 Months	1.7% 4/242 • Number of events 4 • 12 Months
General disorders Oedema peripheral	1.3% 3/238 • Number of events 3 • 12 Months	0.83% 2/242 • Number of events 2 • 12 Months
General disorders Pain	0.00% 0/238 • 12 Months	0.83% 2/242 • Number of events 2 • 12 Months
General disorders Polyp	0.00% 0/238 • 12 Months	0.41% 1/242 • Number of events 1 • 12 Months
General disorders Pyrexia	0.42% 1/238 • Number of events 1 • 12 Months	0.41% 1/242 • Number of events 1 • 12 Months
General disorders Suprapubic pain	0.00% 0/238 • 12 Months	2.5% 6/242 • Number of events 6 • 12 Months
Hepatobiliary disorders Cholecystitis	0.00% 0/238 • 12 Months	0.41% 1/242 • Number of events 1 • 12 Months
Hepatobiliary disorders Cholelithiasis	0.00% 0/238 • 12 Months	0.83% 2/242 • Number of events 2 • 12 Months
Hepatobiliary disorders Hyperplastic cholecystopathy	0.42% 1/238 • Number of events 1 • 12 Months	0.00% 0/242 • 12 Months
Immune system disorders Allergic oedema	0.42% 1/238 • Number of events 1 • 12 Months	0.00% 0/242 • 12 Months
Immune system disorders Drug hypersensitivity	0.00% 0/238 • 12 Months	0.41% 1/242 • Number of events 1 • 12 Months
Immune system disorders Food allergy	0.42% 1/238 • Number of events 1 • 12 Months	0.00% 0/242 • 12 Months
Immune system disorders Hypersensitivity	0.00% 0/238 • 12 Months	1.7% 4/242 • Number of events 4 • 12 Months
Immune system disorders Seasonal allergy	0.42% 1/238 • Number of events 1 • 12 Months	0.00% 0/242 • 12 Months
Infections and infestations Abscess limb	0.00% 0/238 • 12 Months	0.41% 1/242 • Number of events 1 • 12 Months
Infections and infestations Acute sinusitis	0.42% 1/238 • Number of events 1 • 12 Months	1.2% 3/242 • Number of events 3 • 12 Months
Infections and infestations Atypical pneumonia	0.00% 0/238 • 12 Months	0.41% 1/242 • Number of events 1 • 12 Months
Infections and infestations Bacterial vaginosis	0.00% 0/238 • 12 Months	1.7% 4/242 • Number of events 4 • 12 Months
Infections and infestations Balanitis candida	0.00% 0/238 • 12 Months	0.41% 1/242 • Number of events 1 • 12 Months
Infections and infestations Body tinea	0.84% 2/238 • Number of events 2 • 12 Months	0.00% 0/242 • 12 Months
Infections and infestations Bronchitis	1.7% 4/238 • Number of events 4 • 12 Months	1.2% 3/242 • Number of events 3 • 12 Months
Infections and infestations Bronchitis bacterial	0.00% 0/238 • 12 Months	0.41% 1/242 • Number of events 1 • 12 Months
Infections and infestations Bronchitis viral	0.42% 1/238 • Number of events 1 • 12 Months	0.00% 0/242 • 12 Months
Infections and infestations Candida infection	0.84% 2/238 • Number of events 2 • 12 Months	0.00% 0/242 • 12 Months
Infections and infestations Cellulitis	0.42% 1/238 • Number of events 1 • 12 Months	0.83% 2/242 • Number of events 2 • 12 Months
Infections and infestations Cervicitis	0.00% 0/238 • 12 Months	0.41% 1/242 • Number of events 1 • 12 Months
Infections and infestations Chronic sinusitis	0.00% 0/238 • 12 Months	0.41% 1/242 • Number of events 1 • 12 Months
Infections and infestations Clostridium difficile colitis	0.00% 0/238 • 12 Months	0.41% 1/242 • Number of events 1 • 12 Months
Infections and infestations Conjunctivitis	1.7% 4/238 • Number of events 4 • 12 Months	0.41% 1/242 • Number of events 1 • 12 Months
Infections and infestations Diarrhoea infectious	0.00% 0/238 • 12 Months	0.41% 1/242 • Number of events 1 • 12 Months
Infections and infestations Ear infection	0.84% 2/238 • Number of events 2 • 12 Months	0.00% 0/242 • 12 Months
Infections and infestations Eye infection	0.00% 0/238 • 12 Months	0.41% 1/242 • Number of events 1 • 12 Months
Infections and infestations Folliculitis	0.42% 1/238 • Number of events 1 • 12 Months	0.00% 0/242 • 12 Months
Infections and infestations Fungal infection	3.4% 8/238 • Number of events 9 • 12 Months	0.41% 1/242 • Number of events 2 • 12 Months
Infections and infestations Furuncle	0.84% 2/238 • Number of events 2 • 12 Months	0.83% 2/242 • Number of events 2 • 12 Months
Infections and infestations Gastroenteritis	0.84% 2/238 • Number of events 3 • 12 Months	1.2% 3/242 • Number of events 3 • 12 Months
Infections and infestations Gastroenteritis viral	0.42% 1/238 • Number of events 1 • 12 Months	0.00% 0/242 • 12 Months
Infections and infestations Helicobacter infection	0.00% 0/238 • 12 Months	0.83% 2/242 • Number of events 2 • 12 Months
Infections and infestations Herpes simplex	0.00% 0/238 • 12 Months	0.41% 1/242 • Number of events 1 • 12 Months
Infections and infestations Herpes zoster	0.00% 0/238 • 12 Months	0.83% 2/242 • Number of events 2 • 12 Months
Infections and infestations Impetigo	0.42% 1/238 • Number of events 1 • 12 Months	0.00% 0/242 • 12 Months
Infections and infestations Incision site infection	0.42% 1/238 • Number of events 1 • 12 Months	0.41% 1/242 • Number of events 1 • 12 Months
Infections and infestations Infected bunion	0.00% 0/238 • 12 Months	0.41% 1/242 • Number of events 1 • 12 Months
Infections and infestations Influenza	1.3% 3/238 • Number of events 3 • 12 Months	1.7% 4/242 • Number of events 4 • 12 Months
Infections and infestations Nail bed infection fungal	0.00% 0/238 • 12 Months	0.41% 1/242 • Number of events 1 • 12 Months
Infections and infestations Nasopharyngitis	0.84% 2/238 • Number of events 3 • 12 Months	0.41% 1/242 • Number of events 1 • 12 Months
Infections and infestations Onychomycosis	0.00% 0/238 • 12 Months	1.2% 3/242 • Number of events 3 • 12 Months
Infections and infestations Otitis externa	0.84% 2/238 • Number of events 3 • 12 Months	0.00% 0/242 • 12 Months
Infections and infestations Otitis media	0.42% 1/238 • Number of events 1 • 12 Months	0.41% 1/242 • Number of events 1 • 12 Months
Infections and infestations Pharyngitis streptococcal	0.00% 0/238 • 12 Months	0.41% 1/242 • Number of events 1 • 12 Months
Infections and infestations Pneumonia	1.3% 3/238 • Number of events 3 • 12 Months	0.00% 0/242 • 12 Months
Infections and infestations Pyelonephritis acute	0.00% 0/238 • 12 Months	0.41% 1/242 • Number of events 1 • 12 Months
Infections and infestations Rhinitis	0.00% 0/238 • 12 Months	0.41% 1/242 • Number of events 1 • 12 Months
Infections and infestations Sinusitis	3.4% 8/238 • Number of events 9 • 12 Months	3.3% 8/242 • Number of events 8 • 12 Months
Infections and infestations Sinusitis bacterial	0.42% 1/238 • Number of events 1 • 12 Months	0.00% 0/242 • 12 Months
Infections and infestations Skin candida	0.42% 1/238 • Number of events 1 • 12 Months	0.00% 0/242 • 12 Months
Infections and infestations Skin infection	0.00% 0/238 • 12 Months	0.41% 1/242 • Number of events 1 • 12 Months
Infections and infestations Tooth infection	0.00% 0/238 • 12 Months	0.41% 1/242 • Number of events 1 • 12 Months
Infections and infestations Upper respiratory tract infection	4.6% 11/238 • Number of events 12 • 12 Months	2.9% 7/242 • Number of events 7 • 12 Months
Infections and infestations Urinary tract infection	25.2% 60/238 • Number of events 75 • 12 Months	24.0% 58/242 • Number of events 74 • 12 Months
Infections and infestations Vaginal infection	0.42% 1/238 • Number of events 1 • 12 Months	2.1% 5/242 • Number of events 5 • 12 Months
Infections and infestations Vaginitis bacterial	0.42% 1/238 • Number of events 1 • 12 Months	0.00% 0/242 • 12 Months
Infections and infestations Vestibular neuronitis	0.00% 0/238 • 12 Months	0.41% 1/242 • Number of events 1 • 12 Months
Infections and infestations Viral infection	0.00% 0/238 • 12 Months	0.41% 1/242 • Number of events 1 • 12 Months
Infections and infestations Viral upper respiratory tract infection	0.42% 1/238 • Number of events 1 • 12 Months	0.41% 1/242 • Number of events 1 • 12 Months
Infections and infestations Vulvitis	0.00% 0/238 • 12 Months	0.41% 1/242 • Number of events 1 • 12 Months
Infections and infestations Vulvovaginal candidiasis	0.84% 2/238 • Number of events 2 • 12 Months	0.83% 2/242 • Number of events 3 • 12 Months
Infections and infestations Vulvovaginal mycotic infection	0.84% 2/238 • Number of events 2 • 12 Months	1.2% 3/242 • Number of events 3 • 12 Months
Infections and infestations Wound infection	0.00% 0/238 • 12 Months	0.41% 1/242 • Number of events 1 • 12 Months
Injury, poisoning and procedural complications Animal bite	0.84% 2/238 • Number of events 2 • 12 Months	0.00% 0/242 • 12 Months
Injury, poisoning and procedural complications Ankle fracture	0.00% 0/238 • 12 Months	0.41% 1/242 • Number of events 1 • 12 Months
Injury, poisoning and procedural complications Back injury	0.42% 1/238 • Number of events 1 • 12 Months	0.00% 0/242 • 12 Months
Injury, poisoning and procedural complications Bladder injury	0.42% 1/238 • Number of events 1 • 12 Months	0.00% 0/242 • 12 Months
Injury, poisoning and procedural complications Contusion	0.42% 1/238 • Number of events 1 • 12 Months	0.83% 2/242 • Number of events 2 • 12 Months
Injury, poisoning and procedural complications Epicondylitis	0.00% 0/238 • 12 Months	0.41% 1/242 • Number of events 1 • 12 Months
Injury, poisoning and procedural complications Exposure to allergen	0.00% 0/238 • 12 Months	0.41% 1/242 • Number of events 1 • 12 Months
Injury, poisoning and procedural complications Facial bones fracture	0.00% 0/238 • 12 Months	0.41% 1/242 • Number of events 1 • 12 Months
Injury, poisoning and procedural complications Fall	1.7% 4/238 • Number of events 4 • 12 Months	1.2% 3/242 • Number of events 3 • 12 Months
Injury, poisoning and procedural complications Foot fracture	0.84% 2/238 • Number of events 2 • 12 Months	0.00% 0/242 • 12 Months
Injury, poisoning and procedural complications Foreign body	0.00% 0/238 • 12 Months	0.41% 1/242 • Number of events 1 • 12 Months
Injury, poisoning and procedural complications Hand fracture	0.00% 0/238 • 12 Months	0.41% 1/242 • Number of events 1 • 12 Months
Injury, poisoning and procedural complications Humerus fracture	0.42% 1/238 • Number of events 1 • 12 Months	0.00% 0/242 • 12 Months
Injury, poisoning and procedural complications Iliotibial band syndrome	0.00% 0/238 • 12 Months	0.41% 1/242 • Number of events 1 • 12 Months
Injury, poisoning and procedural complications Incision site complication	0.42% 1/238 • Number of events 1 • 12 Months	0.00% 0/242 • 12 Months
Injury, poisoning and procedural complications Incision site haemorrhage	0.00% 0/238 • 12 Months	0.41% 1/242 • Number of events 1 • 12 Months
Injury, poisoning and procedural complications Incision site pain	0.00% 0/238 • 12 Months	0.83% 2/242 • Number of events 2 • 12 Months
Injury, poisoning and procedural complications Joint injury	0.42% 1/238 • Number of events 1 • 12 Months	0.00% 0/242 • 12 Months
Injury, poisoning and procedural complications Laceration	0.42% 1/238 • Number of events 1 • 12 Months	0.00% 0/242 • 12 Months
Injury, poisoning and procedural complications Ligament sprain	0.42% 1/238 • Number of events 1 • 12 Months	0.83% 2/242 • Number of events 2 • 12 Months
Injury, poisoning and procedural complications Limb injury	0.42% 1/238 • Number of events 1 • 12 Months	0.41% 1/242 • Number of events 1 • 12 Months
Injury, poisoning and procedural complications Muscle strain	0.42% 1/238 • Number of events 1 • 12 Months	1.2% 3/242 • Number of events 3 • 12 Months
Injury, poisoning and procedural complications Post procedural haemorrhage	0.42% 1/238 • Number of events 1 • 12 Months	0.00% 0/242 • 12 Months
Injury, poisoning and procedural complications Procedural pain	0.42% 1/238 • Number of events 1 • 12 Months	1.7% 4/242 • Number of events 4 • 12 Months
Injury, poisoning and procedural complications Road traffic accident	0.00% 0/238 • 12 Months	0.41% 1/242 • Number of events 1 • 12 Months
Injury, poisoning and procedural complications Suture related complication	0.00% 0/238 • 12 Months	0.41% 1/242 • Number of events 1 • 12 Months
Injury, poisoning and procedural complications Thermal burn	0.42% 1/238 • Number of events 1 • 12 Months	0.00% 0/242 • 12 Months
Injury, poisoning and procedural complications Vulvovaginal injury	0.00% 0/238 • 12 Months	0.41% 1/242 • Number of events 1 • 12 Months
Injury, poisoning and procedural complications Wound dehiscence	0.00% 0/238 • 12 Months	0.41% 1/242 • Number of events 1 • 12 Months
Injury, poisoning and procedural complications Wrist fracture	0.00% 0/238 • 12 Months	0.41% 1/242 • Number of events 1 • 12 Months
Investigations Anti-thyroid antibody	0.42% 1/238 • Number of events 1 • 12 Months	0.00% 0/242 • 12 Months
Investigations Blood cholesterol increased	0.84% 2/238 • Number of events 2 • 12 Months	0.41% 1/242 • Number of events 1 • 12 Months
Investigations Blood pressure increased	0.42% 1/238 • Number of events 1 • 12 Months	0.83% 2/242 • Number of events 2 • 12 Months
Investigations Blood thyroid stimulating hormone increas	0.42% 1/238 • Number of events 1 • 12 Months	0.00% 0/242 • 12 Months
Investigations C-reactive protein increased	0.00% 0/238 • 12 Months	0.41% 1/242 • Number of events 1 • 12 Months
Investigations Cardiovascular function test abnormal	0.00% 0/238 • 12 Months	0.41% 1/242 • Number of events 1 • 12 Months
Investigations Erythrocytes sedimentation rate increased	0.00% 0/238 • 12 Months	0.41% 1/242 • Number of events 1 • 12 Months
Investigations Glycosylated haemoglobin increased	0.84% 2/238 • Number of events 2 • 12 Months	0.00% 0/242 • 12 Months
Investigations Helicobacter test positive	0.00% 0/238 • 12 Months	0.83% 2/242 • Number of events 2 • 12 Months
Investigations Prealbumin abnormal	0.00% 0/238 • 12 Months	0.41% 1/242 • Number of events 1 • 12 Months
Investigations Vitamin D decreased	0.42% 1/238 • Number of events 1 • 12 Months	0.00% 0/242 • 12 Months
Metabolism and nutrition disorders Dehydration	0.00% 0/238 • 12 Months	0.41% 1/242 • Number of events 1 • 12 Months
Metabolism and nutrition disorders Diabetes mellitus inadequate control	0.42% 1/238 • Number of events 1 • 12 Months	0.00% 0/242 • 12 Months
Metabolism and nutrition disorders Electrolyte imbalance	0.42% 1/238 • Number of events 1 • 12 Months	0.00% 0/242 • 12 Months
Metabolism and nutrition disorders Glucose tolerance impaired	0.42% 1/238 • Number of events 1 • 12 Months	0.41% 1/242 • Number of events 1 • 12 Months
Metabolism and nutrition disorders Hypercholesterolaemia	0.00% 0/238 • 12 Months	0.41% 1/242 • Number of events 1 • 12 Months
Metabolism and nutrition disorders Hypokalaemia	0.00% 0/238 • 12 Months	0.41% 1/242 • Number of events 1 • 12 Months
Metabolism and nutrition disorders Vitamin D deficiency	0.42% 1/238 • Number of events 1 • 12 Months	0.00% 0/242 • 12 Months
Musculoskeletal and connective tissue disorders Arthralgia	2.5% 6/238 • Number of events 8 • 12 Months	7.4% 18/242 • Number of events 24 • 12 Months
Musculoskeletal and connective tissue disorders Arthritis	0.42% 1/238 • Number of events 1 • 12 Months	0.41% 1/242 • Number of events 1 • 12 Months
Musculoskeletal and connective tissue disorders Back pain	5.0% 12/238 • Number of events 12 • 12 Months	7.4% 18/242 • Number of events 20 • 12 Months
Musculoskeletal and connective tissue disorders Bursitis	0.42% 1/238 • Number of events 1 • 12 Months	0.41% 1/242 • Number of events 1 • 12 Months
Musculoskeletal and connective tissue disorders Costochondritis	0.42% 1/238 • Number of events 1 • 12 Months	0.41% 1/242 • Number of events 1 • 12 Months
Musculoskeletal and connective tissue disorders Diastasis recti abdominis	0.00% 0/238 • 12 Months	0.41% 1/242 • Number of events 1 • 12 Months
Musculoskeletal and connective tissue disorders Fibromyalgia	0.42% 1/238 • Number of events 1 • 12 Months	2.1% 5/242 • Number of events 5 • 12 Months
Musculoskeletal and connective tissue disorders Flank pain	0.42% 1/238 • Number of events 1 • 12 Months	0.41% 1/242 • Number of events 1 • 12 Months
Musculoskeletal and connective tissue disorders Groin pain	0.42% 1/238 • Number of events 1 • 12 Months	0.83% 2/242 • Number of events 2 • 12 Months
Musculoskeletal and connective tissue disorders Intervertebral disc annular tear	0.42% 1/238 • Number of events 1 • 12 Months	0.00% 0/242 • 12 Months
Musculoskeletal and connective tissue disorders Intervertebral disc degeneration	0.42% 1/238 • Number of events 1 • 12 Months	0.41% 1/242 • Number of events 1 • 12 Months
Musculoskeletal and connective tissue disorders Joint range of motion decreased	0.00% 0/238 • 12 Months	0.41% 1/242 • Number of events 1 • 12 Months
Musculoskeletal and connective tissue disorders Joint swelling	0.84% 2/238 • Number of events 3 • 12 Months	0.41% 1/242 • Number of events 1 • 12 Months
Musculoskeletal and connective tissue disorders Muscle spasms	0.42% 1/238 • Number of events 1 • 12 Months	1.7% 4/242 • Number of events 5 • 12 Months
Musculoskeletal and connective tissue disorders Muscle tightness	0.42% 1/238 • Number of events 1 • 12 Months	0.00% 0/242 • 12 Months
Musculoskeletal and connective tissue disorders Muscular weakness	0.00% 0/238 • 12 Months	0.41% 1/242 • Number of events 1 • 12 Months
Musculoskeletal and connective tissue disorders Musculoskeletal discomfort	0.00% 0/238 • 12 Months	0.41% 1/242 • Number of events 1 • 12 Months
Musculoskeletal and connective tissue disorders Musculoskeletal pain	1.7% 4/238 • Number of events 4 • 12 Months	0.41% 1/242 • Number of events 1 • 12 Months
Musculoskeletal and connective tissue disorders Myalgia	0.00% 0/238 • 12 Months	0.41% 1/242 • Number of events 1 • 12 Months
Musculoskeletal and connective tissue disorders Myofascial pain syndrome	0.42% 1/238 • Number of events 1 • 12 Months	0.00% 0/242 • 12 Months
Musculoskeletal and connective tissue disorders Neck pain	0.84% 2/238 • Number of events 2 • 12 Months	1.7% 4/242 • Number of events 5 • 12 Months
Musculoskeletal and connective tissue disorders Osteoarthritis	2.9% 7/238 • Number of events 8 • 12 Months	2.1% 5/242 • Number of events 6 • 12 Months
Musculoskeletal and connective tissue disorders Osteoporosis	0.00% 0/238 • 12 Months	0.41% 1/242 • Number of events 1 • 12 Months
Musculoskeletal and connective tissue disorders Pain in extremity	4.6% 11/238 • Number of events 11 • 12 Months	3.3% 8/242 • Number of events 9 • 12 Months
Musculoskeletal and connective tissue disorders Plantar fasciitis	0.42% 1/238 • Number of events 1 • 12 Months	1.7% 4/242 • Number of events 4 • 12 Months
Musculoskeletal and connective tissue disorders Pubic pain	0.00% 0/238 • 12 Months	0.41% 1/242 • Number of events 1 • 12 Months
Musculoskeletal and connective tissue disorders Rheumatoid arthritis	0.84% 2/238 • Number of events 2 • 12 Months	0.00% 0/242 • 12 Months
Musculoskeletal and connective tissue disorders Rotator cuff syndrome	0.00% 0/238 • 12 Months	1.7% 4/242 • Number of events 4 • 12 Months
Musculoskeletal and connective tissue disorders Spinal osteoarthritis	0.00% 0/238 • 12 Months	0.41% 1/242 • Number of events 1 • 12 Months
Musculoskeletal and connective tissue disorders Synovial cyst	0.84% 2/238 • Number of events 2 • 12 Months	0.41% 1/242 • Number of events 1 • 12 Months
Musculoskeletal and connective tissue disorders Systemic lupus erythematosus	0.42% 1/238 • Number of events 1 • 12 Months	0.00% 0/242 • 12 Months
Musculoskeletal and connective tissue disorders Tendonitis	0.42% 1/238 • Number of events 1 • 12 Months	0.41% 1/242 • Number of events 1 • 12 Months
Neoplasms benign, malignant and unspecified (incl cysts and polyps) B-cell lymphoma	0.00% 0/238 • 12 Months	0.41% 1/242 • Number of events 1 • 12 Months
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Benign breast neoplasm	0.00% 0/238 • 12 Months	0.41% 1/242 • Number of events 1 • 12 Months
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer	0.00% 0/238 • 12 Months	0.41% 1/242 • Number of events 1 • 12 Months
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon adenoma	0.00% 0/238 • 12 Months	0.41% 1/242 • Number of events 1 • 12 Months
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lip squamous cell carcinoma	0.00% 0/238 • 12 Months	0.41% 1/242 • Number of events 1 • 12 Months
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Melanocytic naevus	0.42% 1/238 • Number of events 1 • 12 Months	0.41% 1/242 • Number of events 1 • 12 Months
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Ovarian fibroma	0.42% 1/238 • Number of events 1 • 12 Months	0.00% 0/242 • 12 Months
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Seborrhoeic keratosis	0.42% 1/238 • Number of events 1 • 12 Months	0.41% 1/242 • Number of events 1 • 12 Months
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Uterine leiomyoma	0.42% 1/238 • Number of events 1 • 12 Months	0.83% 2/242 • Number of events 2 • 12 Months
Nervous system disorders Amnesia	0.42% 1/238 • Number of events 1 • 12 Months	0.41% 1/242 • Number of events 1 • 12 Months
Nervous system disorders Balance disorder	0.42% 1/238 • Number of events 1 • 12 Months	0.00% 0/242 • 12 Months
Nervous system disorders Burning sensation	0.00% 0/238 • 12 Months	0.41% 1/242 • Number of events 1 • 12 Months
Nervous system disorders Carpal tunnel syndrome	0.84% 2/238 • Number of events 2 • 12 Months	0.41% 1/242 • Number of events 1 • 12 Months
Nervous system disorders Cerebral small vessel ischaemic disease	0.42% 1/238 • Number of events 1 • 12 Months	0.00% 0/242 • 12 Months
Nervous system disorders Cervical radiculopathy	0.00% 0/238 • 12 Months	0.41% 1/242 • Number of events 1 • 12 Months
Nervous system disorders Dizziness	1.7% 4/238 • Number of events 4 • 12 Months	1.2% 3/242 • Number of events 3 • 12 Months
Nervous system disorders Femoral nerve palsy	0.42% 1/238 • Number of events 1 • 12 Months	0.00% 0/242 • 12 Months
Nervous system disorders Headache	2.5% 6/238 • Number of events 6 • 12 Months	3.7% 9/242 • Number of events 10 • 12 Months
Nervous system disorders Hypertensive encephalopathy	0.42% 1/238 • Number of events 1 • 12 Months	0.00% 0/242 • 12 Months
Nervous system disorders Hypoaesthesia	1.3% 3/238 • Number of events 4 • 12 Months	0.41% 1/242 • Number of events 1 • 12 Months
Nervous system disorders Lumbar radiculopathy	0.42% 1/238 • Number of events 1 • 12 Months	0.00% 0/242 • 12 Months
Nervous system disorders Meralgia paraesthetica	0.00% 0/238 • 12 Months	0.41% 1/242 • Number of events 1 • 12 Months
Nervous system disorders Migraine	1.7% 4/238 • Number of events 4 • 12 Months	1.2% 3/242 • Number of events 4 • 12 Months
Nervous system disorders Morton's neuralgia	0.00% 0/238 • 12 Months	0.41% 1/242 • Number of events 1 • 12 Months
Nervous system disorders Neuralgia	0.42% 1/238 • Number of events 1 • 12 Months	0.00% 0/242 • 12 Months
Nervous system disorders Paraesthesia	0.42% 1/238 • Number of events 1 • 12 Months	0.00% 0/242 • 12 Months
Nervous system disorders Piriformis syndrome	0.00% 0/238 • 12 Months	0.41% 1/242 • Number of events 1 • 12 Months
Nervous system disorders Radicular pain	0.00% 0/238 • 12 Months	0.41% 1/242 • Number of events 1 • 12 Months
Nervous system disorders Radiculitis	0.42% 1/238 • Number of events 1 • 12 Months	0.00% 0/242 • 12 Months
Nervous system disorders Radiculopathy	0.42% 1/238 • Number of events 1 • 12 Months	0.41% 1/242 • Number of events 1 • 12 Months
Nervous system disorders Resting tremor	0.00% 0/238 • 12 Months	0.41% 1/242 • Number of events 1 • 12 Months
Nervous system disorders Sciatica	0.42% 1/238 • Number of events 1 • 12 Months	2.5% 6/242 • Number of events 6 • 12 Months
Nervous system disorders Sinus headache	0.00% 0/238 • 12 Months	0.41% 1/242 • Number of events 1 • 12 Months
Nervous system disorders Syncope	0.00% 0/238 • 12 Months	0.41% 1/242 • Number of events 1 • 12 Months
Nervous system disorders Tension headache	0.42% 1/238 • Number of events 1 • 12 Months	0.00% 0/242 • 12 Months
Nervous system disorders Visual field defect	0.00% 0/238 • 12 Months	0.41% 1/242 • Number of events 1 • 12 Months
Psychiatric disorders Anxiety	2.1% 5/238 • Number of events 5 • 12 Months	0.41% 1/242 • Number of events 1 • 12 Months
Psychiatric disorders Anxiety disorder	0.00% 0/238 • 12 Months	0.41% 1/242 • Number of events 1 • 12 Months
Psychiatric disorders Bipolar I disorder	0.00% 0/238 • 12 Months	0.41% 1/242 • Number of events 1 • 12 Months
Psychiatric disorders Depression	2.1% 5/238 • Number of events 5 • 12 Months	0.00% 0/242 • 12 Months
Psychiatric disorders Grief reaction	0.42% 1/238 • Number of events 1 • 12 Months	0.00% 0/242 • 12 Months
Psychiatric disorders Insomnia	0.00% 0/238 • 12 Months	0.83% 2/242 • Number of events 2 • 12 Months
Psychiatric disorders Libido decreased	0.42% 1/238 • Number of events 1 • 12 Months	0.00% 0/242 • 12 Months
Psychiatric disorders Panic attack	0.00% 0/238 • 12 Months	0.41% 1/242 • Number of events 1 • 12 Months
Renal and urinary disorders Bladder pain	0.84% 2/238 • Number of events 2 • 12 Months	0.00% 0/242 • 12 Months
Renal and urinary disorders Bladder perforation	0.42% 1/238 • Number of events 1 • 12 Months	0.41% 1/242 • Number of events 1 • 12 Months
Renal and urinary disorders Cystitis haemorrhagic	0.00% 0/238 • 12 Months	0.41% 1/242 • Number of events 1 • 12 Months
Renal and urinary disorders Dysuria	1.3% 3/238 • Number of events 3 • 12 Months	2.9% 7/242 • Number of events 7 • 12 Months
Renal and urinary disorders Haematuria	0.42% 1/238 • Number of events 1 • 12 Months	0.83% 2/242 • Number of events 2 • 12 Months
Renal and urinary disorders Micturition urgency	1.3% 3/238 • Number of events 3 • 12 Months	0.83% 2/242 • Number of events 2 • 12 Months
Renal and urinary disorders Nephrolithiasis	2.1% 5/238 • Number of events 5 • 12 Months	0.00% 0/242 • 12 Months
Renal and urinary disorders Pollakiuria	0.42% 1/238 • Number of events 2 • 12 Months	0.41% 1/242 • Number of events 1 • 12 Months
Renal and urinary disorders Proteinuria	0.42% 1/238 • Number of events 1 • 12 Months	0.00% 0/242 • 12 Months
Renal and urinary disorders Stress urinary incontinence	0.00% 0/238 • 12 Months	0.41% 1/242 • Number of events 1 • 12 Months
Renal and urinary disorders Urethral discharge	0.42% 1/238 • Number of events 1 • 12 Months	0.00% 0/242 • 12 Months
Renal and urinary disorders Urge incontinence	0.84% 2/238 • Number of events 2 • 12 Months	0.00% 0/242 • 12 Months
Renal and urinary disorders Urinary retention	6.7% 16/238 • Number of events 16 • 12 Months	7.0% 17/242 • Number of events 18 • 12 Months
Reproductive system and breast disorders Adnexa uteri mass	0.00% 0/238 • 12 Months	0.41% 1/242 • Number of events 1 • 12 Months
Reproductive system and breast disorders Atrophic vulvovaginitis	0.84% 2/238 • Number of events 2 • 12 Months	1.2% 3/242 • Number of events 3 • 12 Months
Reproductive system and breast disorders Bartholin's cyst	0.84% 2/238 • Number of events 2 • 12 Months	0.00% 0/242 • 12 Months
Reproductive system and breast disorders Breast discharge	0.00% 0/238 • 12 Months	0.41% 1/242 • Number of events 1 • 12 Months
Reproductive system and breast disorders Breast mass	0.00% 0/238 • 12 Months	0.83% 2/242 • Number of events 2 • 12 Months
Reproductive system and breast disorders Breast pain	0.42% 1/238 • Number of events 1 • 12 Months	0.00% 0/242 • 12 Months
Reproductive system and breast disorders Dyspareunia	5.5% 13/238 • Number of events 13 • 12 Months	4.5% 11/242 • Number of events 11 • 12 Months
Reproductive system and breast disorders Genital pain	6.3% 15/238 • Number of events 15 • 12 Months	1.7% 4/242 • Number of events 4 • 12 Months
Reproductive system and breast disorders Labia enlarged	0.00% 0/238 • 12 Months	0.41% 1/242 • Number of events 1 • 12 Months
Reproductive system and breast disorders Menometrorrhagia	0.42% 1/238 • Number of events 1 • 12 Months	0.00% 0/242 • 12 Months
Reproductive system and breast disorders Menorrhagia	0.00% 0/238 • 12 Months	0.41% 1/242 • Number of events 1 • 12 Months
Reproductive system and breast disorders Metrorrhagia	0.42% 1/238 • Number of events 1 • 12 Months	0.00% 0/242 • 12 Months
Reproductive system and breast disorders Ovarian cyst	0.00% 0/238 • 12 Months	1.2% 3/242 • Number of events 3 • 12 Months
Reproductive system and breast disorders Ovarian cyst ruptured	0.00% 0/238 • 12 Months	0.41% 1/242 • Number of events 1 • 12 Months
Reproductive system and breast disorders Ovulation pain	0.42% 1/238 • Number of events 1 • 12 Months	0.00% 0/242 • 12 Months
Reproductive system and breast disorders Pelvic floor muscle weakness	0.42% 1/238 • Number of events 1 • 12 Months	0.00% 0/242 • 12 Months
Reproductive system and breast disorders Pelvic haematoma	0.00% 0/238 • 12 Months	0.41% 1/242 • Number of events 1 • 12 Months
Reproductive system and breast disorders Pelvic pain	1.7% 4/238 • Number of events 4 • 12 Months	2.5% 6/242 • Number of events 7 • 12 Months
Reproductive system and breast disorders Perineal pain	0.42% 1/238 • Number of events 1 • 12 Months	0.41% 1/242 • Number of events 1 • 12 Months
Reproductive system and breast disorders Postmenopausal haemorrhage	0.00% 0/238 • 12 Months	0.41% 1/242 • Number of events 1 • 12 Months
Reproductive system and breast disorders Pruritus genital	0.42% 1/238 • Number of events 1 • 12 Months	0.00% 0/242 • 12 Months
Reproductive system and breast disorders Vaginal cyst	0.00% 0/238 • 12 Months	0.41% 1/242 • Number of events 1 • 12 Months
Reproductive system and breast disorders Vaginal discharge	0.42% 1/238 • Number of events 1 • 12 Months	0.83% 2/242 • Number of events 2 • 12 Months
Reproductive system and breast disorders Vaginal enlargement	0.42% 1/238 • Number of events 1 • 12 Months	0.00% 0/242 • 12 Months
Reproductive system and breast disorders Vaginal haemorrhage	2.5% 6/238 • Number of events 6 • 12 Months	3.3% 8/242 • Number of events 8 • 12 Months
Reproductive system and breast disorders Vaginal prolapse	0.00% 0/238 • 12 Months	0.41% 1/242 • Number of events 1 • 12 Months
Reproductive system and breast disorders Vulva cyst	0.00% 0/238 • 12 Months	0.41% 1/242 • Number of events 1 • 12 Months
Reproductive system and breast disorders Vulvovaginal burning sensation	0.00% 0/238 • 12 Months	0.41% 1/242 • Number of events 1 • 12 Months
Reproductive system and breast disorders Vulvovaginal discomfort	0.84% 2/238 • Number of events 2 • 12 Months	0.41% 1/242 • Number of events 1 • 12 Months
Reproductive system and breast disorders Vulvovaginal erythema	0.42% 1/238 • Number of events 1 • 12 Months	0.00% 0/242 • 12 Months
Reproductive system and breast disorders Vulvovaginal pain	0.42% 1/238 • Number of events 1 • 12 Months	2.1% 5/242 • Number of events 5 • 12 Months
Reproductive system and breast disorders Vulvovaginal pruritus	1.7% 4/238 • Number of events 4 • 12 Months	1.2% 3/242 • Number of events 3 • 12 Months
Respiratory, thoracic and mediastinal disorders Asthma	2.1% 5/238 • Number of events 6 • 12 Months	2.1% 5/242 • Number of events 6 • 12 Months
Respiratory, thoracic and mediastinal disorders Bronchial hyperreactivity	0.42% 1/238 • Number of events 1 • 12 Months	0.00% 0/242 • 12 Months
Respiratory, thoracic and mediastinal disorders Bronchospasm	0.00% 0/238 • 12 Months	0.41% 1/242 • Number of events 1 • 12 Months
Respiratory, thoracic and mediastinal disorders Choking	0.42% 1/238 • Number of events 1 • 12 Months	0.00% 0/242 • 12 Months
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	0.42% 1/238 • Number of events 1 • 12 Months	0.41% 1/242 • Number of events 1 • 12 Months
Respiratory, thoracic and mediastinal disorders Cough	2.9% 7/238 • Number of events 7 • 12 Months	3.7% 9/242 • Number of events 10 • 12 Months
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.84% 2/238 • Number of events 2 • 12 Months	0.83% 2/242 • Number of events 2 • 12 Months
Respiratory, thoracic and mediastinal disorders Hypoxia	0.00% 0/238 • 12 Months	0.41% 1/242 • Number of events 1 • 12 Months
Respiratory, thoracic and mediastinal disorders Nasal congestion	0.00% 0/238 • 12 Months	0.41% 1/242 • Number of events 1 • 12 Months
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	0.84% 2/238 • Number of events 2 • 12 Months	0.41% 1/242 • Number of events 1 • 12 Months
Respiratory, thoracic and mediastinal disorders Pleurisy	0.00% 0/238 • 12 Months	0.41% 1/242 • Number of events 1 • 12 Months
Respiratory, thoracic and mediastinal disorders Pulmonary mass	0.42% 1/238 • Number of events 1 • 12 Months	0.00% 0/242 • 12 Months
Respiratory, thoracic and mediastinal disorders Rhinitis allergic	0.84% 2/238 • Number of events 2 • 12 Months	0.41% 1/242 • Number of events 1 • 12 Months
Respiratory, thoracic and mediastinal disorders Sleep apnoea syndrome	0.42% 1/238 • Number of events 1 • 12 Months	0.00% 0/242 • 12 Months
Respiratory, thoracic and mediastinal disorders Tonsillar hypertrophy	0.42% 1/238 • Number of events 1 • 12 Months	0.00% 0/242 • 12 Months
Respiratory, thoracic and mediastinal disorders Tonsillolith	0.00% 0/238 • 12 Months	0.41% 1/242 • Number of events 1 • 12 Months
Respiratory, thoracic and mediastinal disorders Upper respiratory tract congestion	0.00% 0/238 • 12 Months	0.41% 1/242 • Number of events 1 • 12 Months
Respiratory, thoracic and mediastinal disorders Wheezing	0.00% 0/238 • 12 Months	0.41% 1/242 • Number of events 1 • 12 Months
Skin and subcutaneous tissue disorders Actinic keratosis	0.42% 1/238 • Number of events 1 • 12 Months	1.2% 3/242 • Number of events 3 • 12 Months
Skin and subcutaneous tissue disorders Alopecia	0.00% 0/238 • 12 Months	0.41% 1/242 • Number of events 1 • 12 Months
Skin and subcutaneous tissue disorders Dermatitis	0.42% 1/238 • Number of events 1 • 12 Months	1.2% 3/242 • Number of events 3 • 12 Months
Skin and subcutaneous tissue disorders Dermatitis allergic	0.00% 0/238 • 12 Months	0.41% 1/242 • Number of events 1 • 12 Months
Skin and subcutaneous tissue disorders Ecchymosis	0.00% 0/238 • 12 Months	0.83% 2/242 • Number of events 2 • 12 Months
Skin and subcutaneous tissue disorders Excessive granulation tissue	0.42% 1/238 • Number of events 1 • 12 Months	0.00% 0/242 • 12 Months
Skin and subcutaneous tissue disorders Hand dermatitis	0.42% 1/238 • Number of events 1 • 12 Months	0.00% 0/242 • 12 Months
Skin and subcutaneous tissue disorders Hyperhidrosis	0.42% 1/238 • Number of events 1 • 12 Months	0.00% 0/242 • 12 Months
Skin and subcutaneous tissue disorders Hyperkeratosis	0.00% 0/238 • 12 Months	0.41% 1/242 • Number of events 1 • 12 Months
Skin and subcutaneous tissue disorders Ingrowing nail	0.42% 1/238 • Number of events 1 • 12 Months	0.00% 0/242 • 12 Months
Skin and subcutaneous tissue disorders Intertrigo	0.00% 0/238 • 12 Months	0.41% 1/242 • Number of events 1 • 12 Months
Skin and subcutaneous tissue disorders Night sweats	0.00% 0/238 • 12 Months	0.41% 1/242 • Number of events 1 • 12 Months
Skin and subcutaneous tissue disorders Pruritus	0.84% 2/238 • Number of events 2 • 12 Months	0.83% 2/242 • Number of events 2 • 12 Months
Skin and subcutaneous tissue disorders Psoriasis	0.00% 0/238 • 12 Months	0.41% 1/242 • Number of events 1 • 12 Months
Skin and subcutaneous tissue disorders Rash	0.42% 1/238 • Number of events 1 • 12 Months	0.41% 1/242 • Number of events 1 • 12 Months
Skin and subcutaneous tissue disorders Skin lesion	0.42% 1/238 • Number of events 1 • 12 Months	0.41% 1/242 • Number of events 1 • 12 Months
Skin and subcutaneous tissue disorders Urticaria	0.84% 2/238 • Number of events 2 • 12 Months	0.41% 1/242 • Number of events 1 • 12 Months
Surgical and medical procedures Bartholin's cyst removal	0.42% 1/238 • Number of events 1 • 12 Months	0.00% 0/242 • 12 Months
Surgical and medical procedures Bladder operation	0.00% 0/238 • 12 Months	0.41% 1/242 • Number of events 1 • 12 Months
Surgical and medical procedures Cataract operation	0.00% 0/238 • 12 Months	0.41% 1/242 • Number of events 1 • 12 Months
Surgical and medical procedures Endodontic procedure	0.42% 1/238 • Number of events 1 • 12 Months	0.41% 1/242 • Number of events 1 • 12 Months
Surgical and medical procedures Foot operation	0.42% 1/238 • Number of events 1 • 12 Months	0.00% 0/242 • 12 Months
Surgical and medical procedures Gastric bypass	0.00% 0/238 • 12 Months	0.41% 1/242 • Number of events 1 • 12 Months
Surgical and medical procedures Incisional drainage	0.00% 0/238 • 12 Months	0.41% 1/242 • Number of events 1 • 12 Months
Surgical and medical procedures Knee arthroplasty	0.00% 0/238 • 12 Months	0.41% 1/242 • Number of events 1 • 12 Months
Surgical and medical procedures Knee operation	0.00% 0/238 • 12 Months	0.41% 1/242 • Number of events 1 • 12 Months
Surgical and medical procedures Mastectomy	0.00% 0/238 • 12 Months	0.41% 1/242 • Number of events 1 • 12 Months
Surgical and medical procedures Medical device implantation	0.42% 1/238 • Number of events 1 • 12 Months	0.00% 0/242 • 12 Months
Surgical and medical procedures Tooth extraction	0.42% 1/238 • Number of events 1 • 12 Months	0.41% 1/242 • Number of events 1 • 12 Months
Surgical and medical procedures Tympanoplasty	0.00% 0/238 • 12 Months	0.41% 1/242 • Number of events 1 • 12 Months
Surgical and medical procedures Umbilical hernia repair	0.42% 1/238 • Number of events 1 • 12 Months	0.00% 0/242 • 12 Months
Surgical and medical procedures Vaginectomy	0.00% 0/238 • 12 Months	0.41% 1/242 • Number of events 1 • 12 Months
Vascular disorders Haematoma	0.00% 0/238 • 12 Months	0.83% 2/242 • Number of events 2 • 12 Months
Vascular disorders Haemorrhage	0.42% 1/238 • Number of events 1 • 12 Months	0.00% 0/242 • 12 Months
Vascular disorders Hot flush	0.84% 2/238 • Number of events 2 • 12 Months	0.00% 0/242 • 12 Months
Vascular disorders Hypertension	1.3% 3/238 • Number of events 3 • 12 Months	0.41% 1/242 • Number of events 1 • 12 Months
Vascular disorders Varicose vein	0.00% 0/238 • 12 Months	0.41% 1/242 • Number of events 1 • 12 Months

Additional Information

Marie Gantz

RTI International

Phone: 919-597-5110

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place