Grouptraining for Overactive Bladder in Adults
- Conditions
- Overactive Bladder
- Interventions
- Behavioral: bladdertraining individuallyBehavioral: bladdertraining in groups
- Registration Number
- NCT01187082
- Lead Sponsor
- University of Aarhus
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 91
- women at the age of 18 and more
- patients with overactive bladder
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description bladdertraining individually bladdertraining individually 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. bladdertraining group bladdertraining in groups 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.
- Primary Outcome Measures
Name Time Method urgencyepisodes after 2 month (end of study) with a bladderdiary episodes are counted at studystart / after 3 sessions of training and after 2 month (studyend)
VAS score from ICI_OAB_Q after 2 month (studyend) with the ICI_OAB_Q counted before studystart / after 3 sessions/ after 2 month (studyend)
urgeincontinence after 2 month (studyend) with a bladderdiary episodes are counted at studystart / after 3 sessions of training and after 2 month (studyend)
- Secondary Outcome Measures
Name Time Method Compliance in training after 2 month (studyend) counted from a pocket bladder schedule at every training session (3 times)and after 2 month (studyend)
voiding frequency after 2 month (studyend) counted from a bladder diary before studystart/ after 3 sessions of training/ after 2 month (studyend)
Adverse events after 2 month (studyend) asked at every training session (3 times)and after 2 month (studyend). Patients are supposed to report in if any AEs during study
Trial Locations
- Locations (5)
Kolding Sygehus, urogynecology department
🇩🇰Kolding, Denmark
Sønderborg Sygehus, Gynækologiske Ambulatorium
🇩🇰Sønderborg, Denmark
Regionshospitalet Viborg, Kontinensklinikken
🇩🇰Viborg, Denmark
Glostrup Hospital
🇩🇰Glostrup, Denmark
Århus Universitetshospital, Skejby, urogynaekology dep.
🇩🇰Århus, Denmark