Web-based Management of Female Stress Urinary Incontinence
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|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||Phase|
|Female Stress Urinary Incontinence||Behavioral: Web-based treatment with PFMT and elements of CBT Behavioral: Pamphlet treatment||Not Applicable|
|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|
|Actual Primary Completion Date :||April 2011|
|Actual 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 ]
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): 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|