Treatment of Stress Urinary Incontinence Via Smartphone
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|ClinicalTrials.gov Identifier: NCT01848938|
Recruitment Status : Completed
First Posted : May 8, 2013
Results First Posted : December 9, 2016
Last Update Posted : April 5, 2017
|Condition or disease||Intervention/treatment||Phase|
|Female Stress Urinary Incontinence||Behavioral: Smartphone treatment with PFMT||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||123 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Treatment of Stress Urinary Incontinence Via Smartphone|
|Study Start Date :||March 2013|
|Actual Primary Completion Date :||November 2014|
|Actual Study Completion Date :||November 2014|
Active Comparator: Smartphone treatment
Smartphone treatment with PFMT.
Behavioral: 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. The treatment period is three months
No Intervention: Waiting list
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) [ Time Frame: baseline, three months ]Three items on frequency, amount of leakage and overall impact. Scoring 0-21, higher values indicating increasing severity
- International Consultation on Incontinence Modular Questionnaire Lower Urinary Tract Symptoms Quality of Life (ICIQ-LUTSqol) [ Time Frame: baseline, three months ]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.
- Usage of Incontinence Aids [ Time Frame: three months ]Usage of incontinence aids during the last 4 weeks.
- Patient Satisfaction [ Time Frame: three months ]A self-rated question about if the current treatment was sufficient, with three response options
- Incontinence Episode Frequency (IEF) [ Time Frame: baseline, three months ]number of incontinence episodes per week
- Patient's Global Impression of Improvement Scale (PGI-I) [ Time Frame: three months ]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".
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01848938
|Umeå, Sweden, S-90185|
|Study Chair:||Eva Samuelsson, MD, PhD||Department of Public Health and Clinical Medicine, Umeå University|