Overactive Bladder
Conditions
Keywords
overactive bladder, women, bladder training, groups
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.
Interventions
BEHAVIORALbladdertraining in groups
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.
BEHAVIORALbladdertraining 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.
Sponsors
University of Aarhus
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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) |
| urgeincontinence | after 2 month (studyend) | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| voiding frequency | after 2 month (studyend) | counted from a bladder diary before studystart/ after 3 sessions of training/ after 2 month (studyend) |
| Compliance in training | after 2 month (studyend) | counted from a pocket bladder schedule at every training session (3 times)and 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 |
Countries
Denmark
Outcome results
None listed