Trial Outcomes & Findings for Treatment of Stress Urinary Incontinence Via Smartphone (NCT NCT01848938)
NCT ID: NCT01848938
Last Updated: 2017-04-05
Results Overview
Three items on frequency, amount of leakage and overall impact. Scoring 0-21, higher values indicating increasing severity
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
123 participants
Primary outcome timeframe
baseline, three months
Results posted on
2017-04-05
Participant Flow
We recruited community-dwelling women, from March 2013 to October 2014, through our website. Interested women filled out a questionnaire to determine whether they met the study criteria. Eligible women received a letter with informed consent and a 2-day leakage diary, and after returning this they also answered a web-based questionnaire.
Randomisation was performed by concealing the allocations in sequentially numbered, opaque, sealed envelopes. An independent administrator generated the allocation sequence and prepared 130 envelopes. The study coordinator opened one envelope for each participant and assigned an e-mail, with materials for the corresponding study group.
Participant milestones
| Measure |
Smartphone Treatment
Smartphone treatment with PFMT.
Smartphone treatment with PFMT: A smartphone application with information on SUI, life style information, different programmes of PFMT with increasing severity, possibility to save statistics on training. Possibility to set reminders. The treatment period is three months
|
Waiting List
Waiting list for three months. They receive the smartphone application after follow-up.
|
|---|---|---|
|
Overall Study
STARTED
|
62
|
61
|
|
Overall Study
COMPLETED
|
61
|
60
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
Reasons for withdrawal
| Measure |
Smartphone Treatment
Smartphone treatment with PFMT.
Smartphone treatment with PFMT: A smartphone application with information on SUI, life style information, different programmes of PFMT with increasing severity, possibility to save statistics on training. Possibility to set reminders. The treatment period is three months
|
Waiting List
Waiting list for three months. They receive the smartphone application after follow-up.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
1
|
Baseline Characteristics
Treatment of Stress Urinary Incontinence Via Smartphone
Baseline characteristics by cohort
| Measure |
Smartphone Treatment
n=62 Participants
Smartphone treatment with pelvic floor muscle training (PFMT).
Smartphone treatment with PFMT: A smartphone application with information on SUI, life style information, different programmes of PFMT with increasing severity, possibility to save statistics on training. Possibility to set reminders. The treatment period is three months
|
Waiting List
n=61 Participants
Waiting list for three months. They receive the smartphone application after follow-up.
|
Total
n=123 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
44.8 years
STANDARD_DEVIATION 9.7 • n=5 Participants
|
44.7 years
STANDARD_DEVIATION 9.1 • n=7 Participants
|
44.7 years
STANDARD_DEVIATION 9.4 • n=5 Participants
|
|
Sex: Female, Male
Female
|
62 Participants
n=5 Participants
|
61 Participants
n=7 Participants
|
123 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
Sweden
|
62 Participants
n=5 Participants
|
61 Participants
n=7 Participants
|
123 Participants
n=5 Participants
|
|
Body Mass Index
|
24.0 kg/m^2
STANDARD_DEVIATION 4.1 • n=5 Participants
|
24.5 kg/m^2
STANDARD_DEVIATION 4.4 • n=7 Participants
|
24.2 kg/m^2
STANDARD_DEVIATION 4.2 • n=5 Participants
|
|
Smoking
smoker
|
2 participants
n=5 Participants
|
3 participants
n=7 Participants
|
5 participants
n=5 Participants
|
|
Smoking
non-smoker
|
60 participants
n=5 Participants
|
58 participants
n=7 Participants
|
118 participants
n=5 Participants
|
|
Education
>=3 years at university level
|
52 participants
n=5 Participants
|
46 participants
n=7 Participants
|
98 participants
n=5 Participants
|
|
Education
<3 years at university level
|
10 participants
n=5 Participants
|
15 participants
n=7 Participants
|
25 participants
n=5 Participants
|
|
Parity
nulliparous
|
5 participants
n=5 Participants
|
4 participants
n=7 Participants
|
9 participants
n=5 Participants
|
|
Parity
not nulliparous
|
57 participants
n=5 Participants
|
57 participants
n=7 Participants
|
114 participants
n=5 Participants
|
|
Regular Medication
on regular medication
|
28 participants
n=5 Participants
|
24 participants
n=7 Participants
|
52 participants
n=5 Participants
|
|
Regular Medication
no regular medication
|
34 participants
n=5 Participants
|
37 participants
n=7 Participants
|
71 participants
n=5 Participants
|
|
Usage of incontinence aids
No use
|
6 participants
n=5 Participants
|
10 participants
n=7 Participants
|
16 participants
n=5 Participants
|
|
Usage of incontinence aids
Less than once a week
|
13 participants
n=5 Participants
|
14 participants
n=7 Participants
|
27 participants
n=5 Participants
|
|
Usage of incontinence aids
1-3 times/week
|
19 participants
n=5 Participants
|
18 participants
n=7 Participants
|
37 participants
n=5 Participants
|
|
Usage of incontinence aids
>3 times/week, but not daily
|
11 participants
n=5 Participants
|
5 participants
n=7 Participants
|
16 participants
n=5 Participants
|
|
Usage of incontinence aids
1 aid a day
|
9 participants
n=5 Participants
|
10 participants
n=7 Participants
|
19 participants
n=5 Participants
|
|
Usage of incontinence aids
More than 1 aid a day
|
4 participants
n=5 Participants
|
4 participants
n=7 Participants
|
8 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: baseline, three monthsPopulation: intention-to-treat analysis
Three items on frequency, amount of leakage and overall impact. Scoring 0-21, higher values indicating increasing severity
Outcome measures
| Measure |
Smartphone Treatment
n=62 Participants
Smartphone treatment with PFMT.
Smartphone treatment with PFMT: A smartphone application with information on SUI, life style information, different programmes of PFMT with increasing severity, possibility to save statistics on training. Possibility to set reminders. The treatment period is three months
|
Waiting List
n=61 Participants
Waiting list for three months. They receive the smartphone application after follow-up.
|
|---|---|---|
|
International Consultation on Incontinence Modular Questionnaire Urinary Incontinence Short Form (ICIQ-UI SF)
baseline
|
11.1 units on a scale
Standard Deviation 3.0
|
11.0 units on a scale
Standard Deviation 2.6
|
|
International Consultation on Incontinence Modular Questionnaire Urinary Incontinence Short Form (ICIQ-UI SF)
3 month follow-up
|
7.0 units on a scale
Standard Deviation 3.5
|
10.2 units on a scale
Standard Deviation 3.2
|
PRIMARY outcome
Timeframe: baseline, three monthsPopulation: intention-to-treat analysis
The instrument includes 19 items on the impact of the leakage. All items are scored 1-4 (not at all/never, slightly/sometimes, moderately/often, a lot/all the time). The overall score is 19-76, with higher values indicating increased impact on QOL.
Outcome measures
| Measure |
Smartphone Treatment
n=62 Participants
Smartphone treatment with PFMT.
Smartphone treatment with PFMT: A smartphone application with information on SUI, life style information, different programmes of PFMT with increasing severity, possibility to save statistics on training. Possibility to set reminders. The treatment period is three months
|
Waiting List
n=61 Participants
Waiting list for three months. They receive the smartphone application after follow-up.
|
|---|---|---|
|
International Consultation on Incontinence Modular Questionnaire Lower Urinary Tract Symptoms Quality of Life (ICIQ-LUTSqol)
baseline
|
34.1 units on a scale
Standard Deviation 6.1
|
34.8 units on a scale
Standard Deviation 6.1
|
|
International Consultation on Incontinence Modular Questionnaire Lower Urinary Tract Symptoms Quality of Life (ICIQ-LUTSqol)
3 month follow-up
|
28.8 units on a scale
Standard Deviation 6.4
|
34.1 units on a scale
Standard Deviation 6.7
|
SECONDARY outcome
Timeframe: three monthsPopulation: intention-to-treat analysis. Missing values at follow-up were replaced with the corresponding values at baseline (i.e., no change).
Usage of incontinence aids during the last 4 weeks.
Outcome measures
| Measure |
Smartphone Treatment
n=62 Participants
Smartphone treatment with PFMT.
Smartphone treatment with PFMT: A smartphone application with information on SUI, life style information, different programmes of PFMT with increasing severity, possibility to save statistics on training. Possibility to set reminders. The treatment period is three months
|
Waiting List
n=61 Participants
Waiting list for three months. They receive the smartphone application after follow-up.
|
|---|---|---|
|
Usage of Incontinence Aids
No use
|
23 participants
|
14 participants
|
|
Usage of Incontinence Aids
Less than once a week
|
13 participants
|
11 participants
|
|
Usage of Incontinence Aids
1-3 times/week
|
10 participants
|
13 participants
|
|
Usage of Incontinence Aids
>3 times/week, but not daily
|
5 participants
|
4 participants
|
|
Usage of Incontinence Aids
1 aid a day
|
8 participants
|
12 participants
|
|
Usage of Incontinence Aids
More than 1 aid a day
|
2 participants
|
6 participants
|
SECONDARY outcome
Timeframe: three monthsPopulation: Data for this outcome measure could only be collected for the smartphone treatment group.
A self-rated question about if the current treatment was sufficient, with three response options
Outcome measures
| Measure |
Smartphone Treatment
n=60 Participants
Smartphone treatment with PFMT.
Smartphone treatment with PFMT: A smartphone application with information on SUI, life style information, different programmes of PFMT with increasing severity, possibility to save statistics on training. Possibility to set reminders. The treatment period is three months
|
Waiting List
Waiting list for three months. They receive the smartphone application after follow-up.
|
|---|---|---|
|
Patient Satisfaction
Yes, I am completely free of leakage
|
5 participants
|
—
|
|
Patient Satisfaction
Yes, sufficient, although I am not completely free
|
35 participants
|
—
|
|
Patient Satisfaction
No
|
20 participants
|
—
|
SECONDARY outcome
Timeframe: baseline, three monthsPopulation: intention-to-treat analysis. Missing values at follow-up were replaced with the corresponding values at baseline (i.e., no change).
number of incontinence episodes per week
Outcome measures
| Measure |
Smartphone Treatment
n=62 Participants
Smartphone treatment with PFMT.
Smartphone treatment with PFMT: A smartphone application with information on SUI, life style information, different programmes of PFMT with increasing severity, possibility to save statistics on training. Possibility to set reminders. The treatment period is three months
|
Waiting List
n=61 Participants
Waiting list for three months. They receive the smartphone application after follow-up.
|
|---|---|---|
|
Incontinence Episode Frequency (IEF)
baseline
|
21.0 episodes per week
Interval 10.5 to 28.0
|
17.5 episodes per week
Interval 10.5 to 24.5
|
|
Incontinence Episode Frequency (IEF)
three month follow-up
|
7 episodes per week
Interval 0.0 to 14.0
|
14 episodes per week
Interval 7.0 to 26.0
|
SECONDARY outcome
Timeframe: three monthsPopulation: intention-to-treat analysis. Missing values at follow-up were replaced with a neutral value (i.e., no change).
A self-rated question that asks about the change experienced after treatment with 7 response options, ranging from "very much better" to "very much worse".
Outcome measures
| Measure |
Smartphone Treatment
n=62 Participants
Smartphone treatment with PFMT.
Smartphone treatment with PFMT: A smartphone application with information on SUI, life style information, different programmes of PFMT with increasing severity, possibility to save statistics on training. Possibility to set reminders. The treatment period is three months
|
Waiting List
n=61 Participants
Waiting list for three months. They receive the smartphone application after follow-up.
|
|---|---|---|
|
Patient's Global Impression of Improvement Scale (PGI-I)
very much better
|
6 participants
|
0 participants
|
|
Patient's Global Impression of Improvement Scale (PGI-I)
much better
|
28 participants
|
3 participants
|
|
Patient's Global Impression of Improvement Scale (PGI-I)
a little better
|
22 participants
|
9 participants
|
|
Patient's Global Impression of Improvement Scale (PGI-I)
no change
|
5 participants
|
42 participants
|
|
Patient's Global Impression of Improvement Scale (PGI-I)
a little worse
|
0 participants
|
6 participants
|
|
Patient's Global Impression of Improvement Scale (PGI-I)
much worse
|
0 participants
|
0 participants
|
|
Patient's Global Impression of Improvement Scale (PGI-I)
very much worse
|
0 participants
|
0 participants
|
Adverse Events
Smartphone Treatment
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Waiting List
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