Trial Outcomes & Findings for Topical Anesthetic Use In Pessary Management (NCT NCT02380742)
NCT ID: NCT02380742
Last Updated: 2017-02-23
Results Overview
Self-reported pain intensity at time of pessary removal controlling for baseline pain. Scale is from 0 to 10 (0=no pain and 10=worst pain)
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
54 participants
Primary outcome timeframe
Removal of Pessary
Results posted on
2017-02-23
Participant Flow
Participant milestones
| Measure |
Lidocaine-prilocaine
4 mL of lidocaine-prilocaine cream
lidocaine-prilocaine cream: The patient will then be positioned in dorsal lithotomy position with the use of stirrups. Two mL of EMLA cream will be placed into the vagina and 2 mL will be spread on the perineum. The cream placed into the vagina will be introduced to the level of the pessary with the practitioners' finger. Once application is completed, a timer will be set for five minutes. After five minutes, the patient will again be placed into dorsal lithotomy position with the use of stirrups. The pessary will be removed per practitioners' usual practice. The patient will be asked to mark her pain score for at this point
|
Placebo
4 mL of placebo cream
Placebo cream: The patient will then be positioned in dorsal lithotomy position with the use of stirrups. Two mL of placebo cream will be placed into the vagina and 2 mL will be spread on the perineum. The cream placed into the vagina will be introduced to the level of the pessary with the practitioners' finger. Once application is completed, a timer will be set for five minutes. After five minutes, the patient will again be placed into dorsal lithotomy position with the use of stirrups. The pessary will be removed per practitioners' usual practice. The patient will be asked to mark her pain score for at this point
|
|---|---|---|
|
Overall Study
STARTED
|
28
|
26
|
|
Overall Study
COMPLETED
|
27
|
26
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
| Measure |
Lidocaine-prilocaine
4 mL of lidocaine-prilocaine cream
lidocaine-prilocaine cream: The patient will then be positioned in dorsal lithotomy position with the use of stirrups. Two mL of EMLA cream will be placed into the vagina and 2 mL will be spread on the perineum. The cream placed into the vagina will be introduced to the level of the pessary with the practitioners' finger. Once application is completed, a timer will be set for five minutes. After five minutes, the patient will again be placed into dorsal lithotomy position with the use of stirrups. The pessary will be removed per practitioners' usual practice. The patient will be asked to mark her pain score for at this point
|
Placebo
4 mL of placebo cream
Placebo cream: The patient will then be positioned in dorsal lithotomy position with the use of stirrups. Two mL of placebo cream will be placed into the vagina and 2 mL will be spread on the perineum. The cream placed into the vagina will be introduced to the level of the pessary with the practitioners' finger. Once application is completed, a timer will be set for five minutes. After five minutes, the patient will again be placed into dorsal lithotomy position with the use of stirrups. The pessary will be removed per practitioners' usual practice. The patient will be asked to mark her pain score for at this point
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
Baseline Characteristics
Topical Anesthetic Use In Pessary Management
Baseline characteristics by cohort
| Measure |
Lidocaine-prilocaine
n=27 Participants
4 mL of lidocaine-prilocaine cream
lidocaine-prilocaine cream: The patient will then be positioned in dorsal lithotomy position with the use of stirrups. Two mL of EMLA cream will be placed into the vagina and 2 mL will be spread on the perineum. The cream placed into the vagina will be introduced to the level of the pessary with the practitioners' finger. Once application is completed, a timer will be set for five minutes. After five minutes, the patient will again be placed into dorsal lithotomy position with the use of stirrups. The pessary will be removed per practitioners' usual practice. The patient will be asked to mark her pain score for at this point
|
Placebo
n=26 Participants
4 mL of placebo cream
Placebo cream: The patient will then be positioned in dorsal lithotomy position with the use of stirrups. Two mL of placebo cream will be placed into the vagina and 2 mL will be spread on the perineum. The cream placed into the vagina will be introduced to the level of the pessary with the practitioners' finger. Once application is completed, a timer will be set for five minutes. After five minutes, the patient will again be placed into dorsal lithotomy position with the use of stirrups. The pessary will be removed per practitioners' usual practice. The patient will be asked to mark her pain score for at this point
|
Total
n=53 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
75.64 years
STANDARD_DEVIATION 10.43 • n=99 Participants
|
79.95 years
STANDARD_DEVIATION 8.01 • n=107 Participants
|
77.76 years
STANDARD_DEVIATION 9.49 • n=206 Participants
|
|
Gender
Female
|
27 Participants
n=99 Participants
|
26 Participants
n=107 Participants
|
53 Participants
n=206 Participants
|
|
Gender
Male
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
23 Participants
n=99 Participants
|
24 Participants
n=107 Participants
|
47 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
25 Participants
n=99 Participants
|
22 Participants
n=107 Participants
|
47 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
|
BMI, Continuous
|
28.11 kg/m^2
STANDARD_DEVIATION 6.06 • n=99 Participants
|
29.47 kg/m^2
STANDARD_DEVIATION 6.59 • n=107 Participants
|
28.78 kg/m^2
STANDARD_DEVIATION 6.30 • n=206 Participants
|
|
Median gravidity (IQR)
|
3 number of pregnancies
n=99 Participants
|
3 number of pregnancies
n=107 Participants
|
3 number of pregnancies
n=206 Participants
|
|
Median parity (range)
|
3 number of viable pregnancies
n=99 Participants
|
3 number of viable pregnancies
n=107 Participants
|
3 number of viable pregnancies
n=206 Participants
|
|
Median pessary months (IQR)
|
18 months
n=99 Participants
|
14 months
n=107 Participants
|
15 months
n=206 Participants
|
|
Median pessary size (IQR)
|
70 mm
n=99 Participants
|
70 mm
n=107 Participants
|
70 mm
n=206 Participants
|
|
Reason for pessary
Prolapse
|
14 participants
n=99 Participants
|
15 participants
n=107 Participants
|
29 participants
n=206 Participants
|
|
Reason for pessary
Incontinence
|
7 participants
n=99 Participants
|
1 participants
n=107 Participants
|
8 participants
n=206 Participants
|
|
Reason for pessary
Prolapse & Incontinence
|
6 participants
n=99 Participants
|
10 participants
n=107 Participants
|
16 participants
n=206 Participants
|
|
Type of pessary
Gelhorn
|
0 participants
n=99 Participants
|
5 participants
n=107 Participants
|
5 participants
n=206 Participants
|
|
Type of pessary
Ring
|
3 participants
n=99 Participants
|
1 participants
n=107 Participants
|
4 participants
n=206 Participants
|
|
Type of pessary
Ring with support
|
13 participants
n=99 Participants
|
10 participants
n=107 Participants
|
23 participants
n=206 Participants
|
|
Type of pessary
Incontinence ring
|
2 participants
n=99 Participants
|
1 participants
n=107 Participants
|
3 participants
n=206 Participants
|
|
Type of pessary
Incontinence dish
|
4 participants
n=99 Participants
|
4 participants
n=107 Participants
|
8 participants
n=206 Participants
|
|
Type of pessary
Incontinence dish with support
|
5 participants
n=99 Participants
|
5 participants
n=107 Participants
|
10 participants
n=206 Participants
|
|
Vaginal erosions
No
|
25 participants
n=99 Participants
|
23 participants
n=107 Participants
|
48 participants
n=206 Participants
|
|
Vaginal erosions
Yes
|
2 participants
n=99 Participants
|
3 participants
n=107 Participants
|
5 participants
n=206 Participants
|
|
Weekly topical estrogen
No
|
20 participants
n=99 Participants
|
16 participants
n=107 Participants
|
36 participants
n=206 Participants
|
|
Weekly topical estrogen
Yes
|
7 participants
n=99 Participants
|
10 participants
n=107 Participants
|
17 participants
n=206 Participants
|
|
Menopausal status
Premenopausal
|
0 participants
n=99 Participants
|
0 participants
n=107 Participants
|
0 participants
n=206 Participants
|
|
Menopausal status
Postmenopausal
|
27 participants
n=99 Participants
|
26 participants
n=107 Participants
|
53 participants
n=206 Participants
|
|
Mean age at menopause (SD)
|
48.67 years
STANDARD_DEVIATION 5.92 • n=99 Participants
|
49.10 years
STANDARD_DEVIATION 6.85 • n=107 Participants
|
48.88 years
STANDARD_DEVIATION 6.33 • n=206 Participants
|
|
Prior hysterectomy
No
|
16 participants
n=99 Participants
|
19 participants
n=107 Participants
|
35 participants
n=206 Participants
|
|
Prior hysterectomy
Yes
|
11 participants
n=99 Participants
|
7 participants
n=107 Participants
|
18 participants
n=206 Participants
|
|
Sexually active
No
|
23 participants
n=99 Participants
|
26 participants
n=107 Participants
|
49 participants
n=206 Participants
|
|
Sexually active
Yes
|
4 participants
n=99 Participants
|
0 participants
n=107 Participants
|
4 participants
n=206 Participants
|
|
Pain with intercourse
No
|
12 participants
n=99 Participants
|
9 participants
n=107 Participants
|
21 participants
n=206 Participants
|
|
Pain with intercourse
Yes
|
0 participants
n=99 Participants
|
0 participants
n=107 Participants
|
0 participants
n=206 Participants
|
|
Pain with intercourse
Not applicable
|
15 participants
n=99 Participants
|
17 participants
n=107 Participants
|
32 participants
n=206 Participants
|
|
Tobacco use
No
|
26 participants
n=99 Participants
|
24 participants
n=107 Participants
|
50 participants
n=206 Participants
|
|
Tobacco use
Yes
|
1 participants
n=99 Participants
|
2 participants
n=107 Participants
|
3 participants
n=206 Participants
|
|
Pessary satisfaction
Dissatisfied
|
0 participants
n=99 Participants
|
0 participants
n=107 Participants
|
0 participants
n=206 Participants
|
|
Pessary satisfaction
Somewhat dissatisfied
|
0 participants
n=99 Participants
|
1 participants
n=107 Participants
|
1 participants
n=206 Participants
|
|
Pessary satisfaction
Neutral
|
1 participants
n=99 Participants
|
0 participants
n=107 Participants
|
1 participants
n=206 Participants
|
|
Pessary satisfaction
Somewhat satisfied
|
4 participants
n=99 Participants
|
6 participants
n=107 Participants
|
10 participants
n=206 Participants
|
|
Pessary satisfaction
Very satisfied
|
22 participants
n=99 Participants
|
19 participants
n=107 Participants
|
41 participants
n=206 Participants
|
|
Baseline VAS scores
Mean paper form
|
0.29 units on a scale
STANDARD_DEVIATION 0.73 • n=99 Participants
|
0.23 units on a scale
STANDARD_DEVIATION 0.48 • n=107 Participants
|
0.26 units on a scale
STANDARD_DEVIATION 0.61 • n=206 Participants
|
|
Baseline VAS scores
Mean electronic form
|
0.51 units on a scale
STANDARD_DEVIATION 0.69 • n=99 Participants
|
0.52 units on a scale
STANDARD_DEVIATION 0.51 • n=107 Participants
|
0.52 units on a scale
STANDARD_DEVIATION 0.60 • n=206 Participants
|
PRIMARY outcome
Timeframe: Removal of PessarySelf-reported pain intensity at time of pessary removal controlling for baseline pain. Scale is from 0 to 10 (0=no pain and 10=worst pain)
Outcome measures
| Measure |
Lidocaine-prilocaine
n=27 Participants
4 mL of lidocaine-prilocaine cream
lidocaine-prilocaine cream: The patient will then be positioned in dorsal lithotomy position with the use of stirrups. Two mL of EMLA cream will be placed into the vagina and 2 mL will be spread on the perineum. The cream placed into the vagina will be introduced to the level of the pessary with the practitioners' finger. Once application is completed, a timer will be set for five minutes. After five minutes, the patient will again be placed into dorsal lithotomy position with the use of stirrups. The pessary will be removed per practitioners' usual practice. The patient will be asked to mark her pain score for at this point
|
Placebo
n=26 Participants
4 mL of placebo cream
Placebo cream: The patient will then be positioned in dorsal lithotomy position with the use of stirrups. Two mL of placebo cream will be placed into the vagina and 2 mL will be spread on the perineum. The cream placed into the vagina will be introduced to the level of the pessary with the practitioners' finger. Once application is completed, a timer will be set for five minutes. After five minutes, the patient will again be placed into dorsal lithotomy position with the use of stirrups. The pessary will be removed per practitioners' usual practice. The patient will be asked to mark her pain score for at this point
|
|---|---|---|
|
VAS Score at the Time of Pessary Removal Adjusting for Baseline Pain
|
1.76 Centimeters
Standard Error 0.57
|
3.81 Centimeters
Standard Error 0.58
|
SECONDARY outcome
Timeframe: Removal of PessarySelf-reported pain intensity at time of pessary removal after controlling for pessary type and investigator training level. Scale is from 0 to 10 centimeters (0=no pain and 10=worst pain)
Outcome measures
| Measure |
Lidocaine-prilocaine
n=27 Participants
4 mL of lidocaine-prilocaine cream
lidocaine-prilocaine cream: The patient will then be positioned in dorsal lithotomy position with the use of stirrups. Two mL of EMLA cream will be placed into the vagina and 2 mL will be spread on the perineum. The cream placed into the vagina will be introduced to the level of the pessary with the practitioners' finger. Once application is completed, a timer will be set for five minutes. After five minutes, the patient will again be placed into dorsal lithotomy position with the use of stirrups. The pessary will be removed per practitioners' usual practice. The patient will be asked to mark her pain score for at this point
|
Placebo
n=26 Participants
4 mL of placebo cream
Placebo cream: The patient will then be positioned in dorsal lithotomy position with the use of stirrups. Two mL of placebo cream will be placed into the vagina and 2 mL will be spread on the perineum. The cream placed into the vagina will be introduced to the level of the pessary with the practitioners' finger. Once application is completed, a timer will be set for five minutes. After five minutes, the patient will again be placed into dorsal lithotomy position with the use of stirrups. The pessary will be removed per practitioners' usual practice. The patient will be asked to mark her pain score for at this point
|
|---|---|---|
|
VAS Score at the Time of Pessary Removal Adjusting for Pessary Type and Investigator Training
|
1.81 Centimeters
Standard Error 0.59
|
3.76 Centimeters
Standard Error 0.60
|
SECONDARY outcome
Timeframe: Removal of PessarySelf-reported pain intensity at time of pessary removal after controlling for patient age and baseline pain score. Scale is from 0 to 10 centimeters (0=no pain and 10=worst pain)
Outcome measures
| Measure |
Lidocaine-prilocaine
n=27 Participants
4 mL of lidocaine-prilocaine cream
lidocaine-prilocaine cream: The patient will then be positioned in dorsal lithotomy position with the use of stirrups. Two mL of EMLA cream will be placed into the vagina and 2 mL will be spread on the perineum. The cream placed into the vagina will be introduced to the level of the pessary with the practitioners' finger. Once application is completed, a timer will be set for five minutes. After five minutes, the patient will again be placed into dorsal lithotomy position with the use of stirrups. The pessary will be removed per practitioners' usual practice. The patient will be asked to mark her pain score for at this point
|
Placebo
n=26 Participants
4 mL of placebo cream
Placebo cream: The patient will then be positioned in dorsal lithotomy position with the use of stirrups. Two mL of placebo cream will be placed into the vagina and 2 mL will be spread on the perineum. The cream placed into the vagina will be introduced to the level of the pessary with the practitioners' finger. Once application is completed, a timer will be set for five minutes. After five minutes, the patient will again be placed into dorsal lithotomy position with the use of stirrups. The pessary will be removed per practitioners' usual practice. The patient will be asked to mark her pain score for at this point
|
|---|---|---|
|
VAS Score at the Time of Pessary Removal Adjusting for Baseline Pain and Patient Age
|
1.88 Centimeters
Standard Error 0.58
|
3.69 Centimeters
Standard Error 0.59
|
SECONDARY outcome
Timeframe: Insertion of PessaryPopulation: After baseline and removal study activities were recorded, one of the patients in the placebo group was withdrawn by the investigator due to vaginal erosion.
Practitioner's perception of patient's pain score at time of pessary insertion adjusting for baseline pain. Scale is from 0 to 10 centimeters (0=no pain and 10=worst pain)
Outcome measures
| Measure |
Lidocaine-prilocaine
n=27 Participants
4 mL of lidocaine-prilocaine cream
lidocaine-prilocaine cream: The patient will then be positioned in dorsal lithotomy position with the use of stirrups. Two mL of EMLA cream will be placed into the vagina and 2 mL will be spread on the perineum. The cream placed into the vagina will be introduced to the level of the pessary with the practitioners' finger. Once application is completed, a timer will be set for five minutes. After five minutes, the patient will again be placed into dorsal lithotomy position with the use of stirrups. The pessary will be removed per practitioners' usual practice. The patient will be asked to mark her pain score for at this point
|
Placebo
n=25 Participants
4 mL of placebo cream
Placebo cream: The patient will then be positioned in dorsal lithotomy position with the use of stirrups. Two mL of placebo cream will be placed into the vagina and 2 mL will be spread on the perineum. The cream placed into the vagina will be introduced to the level of the pessary with the practitioners' finger. Once application is completed, a timer will be set for five minutes. After five minutes, the patient will again be placed into dorsal lithotomy position with the use of stirrups. The pessary will be removed per practitioners' usual practice. The patient will be asked to mark her pain score for at this point
|
|---|---|---|
|
VAS Score at the Time of Pessary Insertion Adjusting for Baseline Pain
|
0.61 Centimeters
Standard Error 0.43
|
1.68 Centimeters
Standard Error 0.44
|
Adverse Events
Lidocaine-prilocaine
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place