Grouptraining for Overactive Bladder in Adults

Study Overview
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Brief Summary
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Hypothesis:the effect of bladdertraining in groups for patients with OAB (overactive bladder syndrome) equals the effect of bladdertraining individually for patients with overactive bladder. The effect of the training is measured in a 3 dimensional scope by the means of 3 primary outcome measures used in the statistical evaluation. Symptoms of OAB (either (1)urgencyepisodes or (2)urgencyincontinence) and (3)quality of life (VAS score).

Detailed Description
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Program consisting of 3 hourly sessions with bladdertraining and daily training with a pocket bladder schedule. patients are randomised either for groups or individual training with a continence nurse over a period of 2 months.

Official Title
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A Clinical, Randomized, Comparative, Non-blinded Study on the Effect of Bladdertraining in Groups Compared to Individual Bladdertraining for Female Patients With Overactive Bladder.

Conditions
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Overactive Bladder

Intervention / Treatment
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* Behavioral: bladdertraining in groups
* Behavioral: bladdertraining individually


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: women at the age of 18 and more patients with overactive bladder Exclusion Criteria: dominance of stress incontinence not able to attend sessions do not to understand danish do not want training in groups or individual hormonebalanced (if postmenopausal with added hormonetreatment for at least 2 months) no treatment for OAB up till 1 month before study and during study no renal or neurological diseases, symptomatic cystitis or non regulated diabetes no pregnancy during study no normal gynecological examination no operation in pelvis up till 3 month before studystart no polyuria measured 2 times before studystart (> 40 ml/ kg/ day) no upstart of treatment with medication during studystart which according to the investigator can create symptoms of OAB no participation in other CT

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: bladdertraining group<br>Cognitive training in groups at hospital by a continence nurse in 3 sessions (1 hour)over a period of 1 month. Follow up after 1 month. During all 2 month the patient has selfinitiatied daily training with a pocket bladder schedule. | Behavioral: bladdertraining in groups<br>* Cognitive training in groups of 4 patients at hospital by a continence nurse in 3 sessions (1 hour)over a period of 1 month. Follow up after 1 month. During all 2 month the patient has selfinitiatied daily training with a pocket bladder schedule.<br>|
| Active Comparator: bladdertraining individually<br>Cognitive training individually at hospital by a continence nurse in 3 sessions (1 hour)over a period of 1 month. Follow up after 1 month. During all 2 month the patient has selfinitiatied daily training with a pocket bladder schedule. | Behavioral: bladdertraining individually<br>* Cognitive training individually at hospital by a continence nurse in 3 sessions (1 hour)over a period of 1 month. Follow up after 1 month. During all 2 month the patient has selfinitiatied daily training with a pocket bladder schedule.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| urgencyepisodes | with a bladderdiary episodes are counted at studystart / after 3 sessions of training and after 2 month (studyend) | after 2 month (end of study) | 
| urgeincontinence | with a bladderdiary episodes are counted at studystart / after 3 sessions of training and after 2 month (studyend) | after 2 month (studyend) | 
| VAS score from ICI_OAB_Q | with the ICI_OAB_Q counted before studystart / after 3 sessions/ after 2 month (studyend) | after 2 month (studyend) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| voiding frequency | counted from a bladder diary before studystart/ after 3 sessions of training/ after 2 month (studyend) | after 2 month (studyend) | 
| Compliance in training | counted from a pocket bladder schedule at every training session (3 times)and after 2 month (studyend) | after 2 month (studyend) | 
| Adverse events | asked at every training session (3 times)and after 2 month (studyend). Patients are supposed to report in if any AEs during study | after 2 month (studyend) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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overactive bladder, women, bladder training, groups