Web-based Management of Female Stress Urinary Incontinence
|ClinicalTrials.gov Identifier: NCT01032265|
Recruitment Status : Completed
First Posted : December 15, 2009
Results First Posted : March 13, 2013
Last Update Posted : March 13, 2013
|Condition or disease||Intervention/treatment|
|Female Stress Urinary Incontinence||Behavioral: Web-based treatment with PFMT and elements of CBT Behavioral: Pamphlet treatment|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||250 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Web-based Management of Female Stress Urinary Incontinence. Evaluation of a Treatment Programme With Pelvic Floor Muscle Training and Elements of Cognitive Behavioural Therapy|
|Study Start Date :||December 2009|
|Primary Completion Date :||April 2011|
|Study Completion Date :||April 2011|
Active Comparator: Web-based treatment
Web-based treatment with information (including life style), PFMT, elements of CBT and regular mail contact with an urotherapist
Behavioral: Web-based treatment with PFMT and elements of CBT
125 women with stress urinary incontinence(SUI) participate in web-based treatment for 3 months. Treatment consists of information, PFMT and uses elements of CBT. It includes regular email contact with urotherapist.
Active Comparator: Pamphlet treatment
Information (including life style), and PFMT exercises.
Behavioral: Pamphlet treatment
125 women with SUI receive a pamphlet with information and a programme for PFMT.
- International Consultation on Incontinence Modular Questionnaire Urinary Incontinence Short Form (ICIQ-UI SF) [ Time Frame: baseline, 4 months ]summed symptom-score, range 0-21, with higher scores indicating greater severity.
- International Consultation on Incontinence Modular Questionnaire Lower Urinary Tract Symptoms Quality of Life (ICIQ-LUTSqol) [ Time Frame: baseline, 4 months ]condition-specific quality of life, summed score, range 19-76, higher scores indicate greater impact on quality of life.
- EuroQol Five Dimensions Visual Analogue Scale (EQ5D-VAS) [ Time Frame: baseline, 4 months ]health-specific quality of life, range 0-100, higher scores indicate better quality of life.
- Usage of Incontinence Aids [ Time Frame: baseline, 4 months ]Only those using incontinence aids at baseline were included in the analysis.
- Patient Satisfaction [ Time Frame: 4 months ]
- Incontinence Episode Frequency (IEF) [ Time Frame: baseline, 4 months ]number of incontinence episodes per week
- Patient`s Global Impression of Improvement Scale (PGI-I) [ Time Frame: 4 months ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01032265
|Umeå, Sweden, S-90185|
|Study Chair:||Eva Samuelsson, MD, PhD||Department of Public Health and Clinical Medicine, Umeå University|
|Principal Investigator:||Eva Samuelsson, MD, PhD||Department of Public Health and Clinical Medicine, Umeå University|
|Principal Investigator:||Göran Umefjord, MD, PhD||Department of Public Health and Clinical Medicine, Umeå University|