Treatment of Stress Urinary Incontinence Via Smartphone
|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|
Show Detailed Description
|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".
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|