A Clinical, Randomized, Comparative, Non-blinded Study on the Effect of Bladdertraining in Groups Compared to Individual Bladdertraining for Female Patients With Overactive Bladder.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Aarhus
- Enrollment
- 91
- Locations
- 5
- Primary Endpoint
- urgencyepisodes
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Health Services Research
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
bladdertraining group
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.
Intervention: bladdertraining in groups (Behavioral)
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.
Intervention: bladdertraining individually (Behavioral)
Outcomes
Primary Outcomes
urgencyepisodes
Time Frame: 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
Time Frame: after 2 month (studyend)
with the ICI_OAB_Q counted before studystart / after 3 sessions/ after 2 month (studyend)
urgeincontinence
Time Frame: after 2 month (studyend)
with a bladderdiary episodes are counted at studystart / after 3 sessions of training and after 2 month (studyend)
Secondary Outcomes
- Compliance in training(after 2 month (studyend))
- voiding frequency(after 2 month (studyend))
- Adverse events(after 2 month (studyend))