Trial Outcomes & Findings for Web-based Management of Female Stress Urinary Incontinence (NCT NCT01032265)
NCT ID: NCT01032265
Last Updated: 2022-03-02
Results Overview
summed symptom-score, range 0-21, with higher scores indicating greater severity.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
250 participants
Primary outcome timeframe
baseline, 4 months
Results posted on
2022-03-02
Participant Flow
Online recruitment via the project´s open access website, Dec 2009 - Oct 2010. Interested women answered an online survey for screening of the eligibility criteria. If eligible they were sent a postal questionnaire, including a 2-day bladder diary. Finally, to confirm the clinical diagnosis all women were interviewed by telephone by a urotherapist.
Randomisation was through a pre-specified computer-generated list, in blocks of eight. An independent administrator kept the list and consecutively allocated eligible participants to one of the two intervention groups. There was no blinding of group allocation to study participants, health care providers, or researchers.
Participant milestones
| Measure |
Postal Treatment
Information (including life style), and PFMT exercises.
|
Internet-based Treatment
Internet-based treatment with information (including life style), PFMT, elements of CBT and regular mail contact with an urotherapist
|
|---|---|---|
|
Overall Study
STARTED
|
126
|
124
|
|
Overall Study
COMPLETED
|
113
|
107
|
|
Overall Study
NOT COMPLETED
|
13
|
17
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Web-based Management of Female Stress Urinary Incontinence
Baseline characteristics by cohort
| Measure |
Postal Treatment
n=126 Participants
Information (including life style), and PFMT exercises.
|
Internet-based Treatment
n=124 Participants
Internet-based treatment with information (including life style), PFMT, elements of CBT and regular mail contact with an urotherapist
|
Total
n=250 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
49.4 years
STANDARD_DEVIATION 9.8 • n=39 Participants
|
47.9 years
STANDARD_DEVIATION 10.6 • n=41 Participants
|
48.6 years
STANDARD_DEVIATION 10.2 • n=35 Participants
|
|
Sex: Female, Male
Female
|
126 Participants
n=39 Participants
|
124 Participants
n=41 Participants
|
250 Participants
n=35 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Region of Enrollment
Sweden
|
126 participants
n=39 Participants
|
124 participants
n=41 Participants
|
250 participants
n=35 Participants
|
|
Body Mass index
|
24.5 kg/m2
STANDARD_DEVIATION 3.6 • n=39 Participants
|
24.7 kg/m2
STANDARD_DEVIATION 4.2 • n=41 Participants
|
24.6 kg/m2
STANDARD_DEVIATION 3.9 • n=35 Participants
|
|
Smoking
Smoker
|
5 Participants
n=39 Participants
|
4 Participants
n=41 Participants
|
9 Participants
n=35 Participants
|
|
Smoking
Non-smoker
|
121 Participants
n=39 Participants
|
120 Participants
n=41 Participants
|
241 Participants
n=35 Participants
|
|
Education
>=3 years at university level
|
72 Participants
n=39 Participants
|
63 Participants
n=41 Participants
|
135 Participants
n=35 Participants
|
|
Education
< 3 years at university level
|
28 Participants
n=39 Participants
|
25 Participants
n=41 Participants
|
53 Participants
n=35 Participants
|
|
Education
Lower
|
26 Participants
n=39 Participants
|
36 Participants
n=41 Participants
|
62 Participants
n=35 Participants
|
|
Number of births (Parity)
No childbirth
|
7 Participants
n=39 Participants
|
11 Participants
n=41 Participants
|
18 Participants
n=35 Participants
|
|
Number of births (Parity)
1 child
|
15 Participants
n=39 Participants
|
20 Participants
n=41 Participants
|
35 Participants
n=35 Participants
|
|
Number of births (Parity)
2 children
|
62 Participants
n=39 Participants
|
61 Participants
n=41 Participants
|
123 Participants
n=35 Participants
|
|
Number of births (Parity)
3 children
|
31 Participants
n=39 Participants
|
21 Participants
n=41 Participants
|
52 Participants
n=35 Participants
|
|
Number of births (Parity)
4 children
|
11 Participants
n=39 Participants
|
11 Participants
n=41 Participants
|
22 Participants
n=35 Participants
|
|
Menopausal status
Postmenopausal
|
48 Participants
n=39 Participants
|
43 Participants
n=41 Participants
|
91 Participants
n=35 Participants
|
|
Menopausal status
Not postmenopausal
|
73 Participants
n=39 Participants
|
77 Participants
n=41 Participants
|
150 Participants
n=35 Participants
|
|
Menopausal status
Unknown
|
5 Participants
n=39 Participants
|
4 Participants
n=41 Participants
|
9 Participants
n=35 Participants
|
|
Baseline characteristics for postal treatment group, internet-based treatment group and total
|
126 participants
n=39 Participants
|
124 participants
n=41 Participants
|
250 participants
n=35 Participants
|
PRIMARY outcome
Timeframe: baseline, 4 monthsPopulation: Intention-to-treat
summed symptom-score, range 0-21, with higher scores indicating greater severity.
Outcome measures
| Measure |
Postal Treatment
n=113 Participants
Information (including life style), and PFMT exercises.
|
Internet-based Treatment
n=107 Participants
Internet-based treatment with information (including life style), PFMT, elements of CBT and regular mail contact with an urotherapist
|
|---|---|---|
|
International Consultation on Incontinence Modular Questionnaire Urinary Incontinence Short Form (ICIQ-UI SF)
Baseline
|
10.3 units on a scale
Standard Deviation 3.5
|
10.4 units on a scale
Standard Deviation 3.1
|
|
International Consultation on Incontinence Modular Questionnaire Urinary Incontinence Short Form (ICIQ-UI SF)
4 month follow-up
|
7.3 units on a scale
Standard Deviation 3.9
|
6.9 units on a scale
Standard Deviation 3.1
|
PRIMARY outcome
Timeframe: baseline, 4 monthsPopulation: Intention-to-treat
condition-specific quality of life, summed score, range 19-76, higher scores indicate greater impact on quality of life.
Outcome measures
| Measure |
Postal Treatment
n=113 Participants
Information (including life style), and PFMT exercises.
|
Internet-based Treatment
n=107 Participants
Internet-based treatment with information (including life style), PFMT, elements of CBT and regular mail contact with an urotherapist
|
|---|---|---|
|
International Consultation on Incontinence Modular Questionnaire Lower Urinary Tract Symptoms Quality of Life (ICIQ-LUTSqol)
Baseline
|
33.6 units on a scale
Standard Deviation 8.2
|
33.6 units on a scale
Standard Deviation 6.8
|
|
International Consultation on Incontinence Modular Questionnaire Lower Urinary Tract Symptoms Quality of Life (ICIQ-LUTSqol)
4 month follow-up
|
28.8 units on a scale
Standard Deviation 7.3
|
27.8 units on a scale
Standard Deviation 6.0
|
SECONDARY outcome
Timeframe: baseline, 4 monthsPopulation: Intention-to-treat
health-specific quality of life, range 0-100, higher scores indicate better quality of life.
Outcome measures
| Measure |
Postal Treatment
n=113 Participants
Information (including life style), and PFMT exercises.
|
Internet-based Treatment
n=107 Participants
Internet-based treatment with information (including life style), PFMT, elements of CBT and regular mail contact with an urotherapist
|
|---|---|---|
|
EuroQol Five Dimensions Visual Analogue Scale (EQ5D-VAS)
Baseline
|
79.2 units on a scale
Standard Deviation 14.0
|
79.1 units on a scale
Standard Deviation 13.6
|
|
EuroQol Five Dimensions Visual Analogue Scale (EQ5D-VAS)
4 month follow-up
|
81.8 units on a scale
Standard Deviation 13.9
|
83.3 units on a scale
Standard Deviation 10.3
|
SECONDARY outcome
Timeframe: baseline, 4 monthsPopulation: Intention-to-treat
Only those using incontinence aids at baseline were included in the analysis.
Outcome measures
| Measure |
Postal Treatment
n=82 Participants
Information (including life style), and PFMT exercises.
|
Internet-based Treatment
n=79 Participants
Internet-based treatment with information (including life style), PFMT, elements of CBT and regular mail contact with an urotherapist
|
|---|---|---|
|
Usage of Incontinence Aids
No use
|
11 participants
|
17 participants
|
|
Usage of Incontinence Aids
Less than before
|
23 participants
|
30 participants
|
|
Usage of Incontinence Aids
Same as before
|
46 participants
|
32 participants
|
|
Usage of Incontinence Aids
More than before
|
2 participants
|
0 participants
|
SECONDARY outcome
Timeframe: 4 monthsPopulation: Intention-to-treat
Outcome measures
| Measure |
Postal Treatment
n=113 Participants
Information (including life style), and PFMT exercises.
|
Internet-based Treatment
n=107 Participants
Internet-based treatment with information (including life style), PFMT, elements of CBT and regular mail contact with an urotherapist
|
|---|---|---|
|
Patient Satisfaction
very good
|
15 participants
|
46 participants
|
|
Patient Satisfaction
good
|
56 participants
|
43 participants
|
|
Patient Satisfaction
neither good or bad
|
31 participants
|
13 participants
|
|
Patient Satisfaction
bad
|
8 participants
|
3 participants
|
|
Patient Satisfaction
very bad
|
3 participants
|
0 participants
|
|
Patient Satisfaction
Missing
|
0 participants
|
2 participants
|
SECONDARY outcome
Timeframe: baseline, 4 monthsPopulation: Intention-to-treat
number of incontinence episodes per week
Outcome measures
| Measure |
Postal Treatment
n=113 Participants
Information (including life style), and PFMT exercises.
|
Internet-based Treatment
n=107 Participants
Internet-based treatment with information (including life style), PFMT, elements of CBT and regular mail contact with an urotherapist
|
|---|---|---|
|
Incontinence Episode Frequency (IEF)
Baseline
|
9.4 episodes per week
Standard Deviation 8.6
|
12.7 episodes per week
Standard Deviation 12.0
|
|
Incontinence Episode Frequency (IEF)
4 month follow-up
|
4.4 episodes per week
Standard Deviation 6.7
|
4.8 episodes per week
Standard Deviation 7.7
|
SECONDARY outcome
Timeframe: 4 monthsPopulation: Intention-to-treat
Outcome measures
| Measure |
Postal Treatment
n=113 Participants
Information (including life style), and PFMT exercises.
|
Internet-based Treatment
n=107 Participants
Internet-based treatment with information (including life style), PFMT, elements of CBT and regular mail contact with an urotherapist
|
|---|---|---|
|
Patient's Global Impression of Improvement Scale (PGI-I)
very much better
|
4 participants
|
12 participants
|
|
Patient's Global Impression of Improvement Scale (PGI-I)
much better
|
26 participants
|
31 participants
|
|
Patient's Global Impression of Improvement Scale (PGI-I)
Missing
|
0 participants
|
2 participants
|
|
Patient's Global Impression of Improvement Scale (PGI-I)
a little better
|
60 participants
|
48 participants
|
|
Patient's Global Impression of Improvement Scale (PGI-I)
no change
|
19 participants
|
13 participants
|
|
Patient's Global Impression of Improvement Scale (PGI-I)
a little worse
|
3 participants
|
1 participants
|
|
Patient's Global Impression of Improvement Scale (PGI-I)
much worse
|
1 participants
|
0 participants
|
|
Patient's Global Impression of Improvement Scale (PGI-I)
very much worse
|
0 participants
|
0 participants
|
Adverse Events
Postal Treatment
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Internet-based Treatment
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Postal Treatment
n=126 participants at risk
Information (including life style), and PFMT exercises.
|
Internet-based Treatment
n=124 participants at risk
Internet-based treatment with information (including life style), PFMT, elements of CBT and regular mail contact with an urotherapist
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
Lower abdominal pain when performing pelvic floor muscle training
|
0.00%
0/126 • 4 months
|
0.81%
1/124 • Number of events 1 • 4 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place