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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| bladdertraining group | Experimental | 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. |
|
| bladdertraining individually | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| bladdertraining in groups | Behavioral | 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. |
| 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) |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kirsten Kaysen, nurse | Århus Universitetshospital, Skejby | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Århus Universitetshospital, Skejby, urogynaekology dep. | Aarhus | 8300 | Denmark | |||
| Glostrup Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37811598 | Derived | Funada S, Yoshioka T, Luo Y, Sato A, Akamatsu S, Watanabe N. Bladder training for treating overactive bladder in adults. Cochrane Database Syst Rev. 2023 Oct 9;10(10):CD013571. doi: 10.1002/14651858.CD013571.pub2. |
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| ID | Term |
|---|---|
| D053201 | Urinary Bladder, Overactive |
| ID | Term |
|---|---|
| D001745 | Urinary Bladder Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| ID | Term |
|---|---|
| D044382 | Population Groups |
| ID | Term |
|---|---|
| D003710 | Demography |
| D011154 | Population Characteristics |
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|
| bladdertraining individually | Behavioral | 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. |
|
| 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) |
| Glostrup Municipality |
| 2600 |
| Denmark |
| Kolding Sygehus, urogynecology department | Kolding | 6000 | Denmark |
| Sønderborg Sygehus, Gynækologiske Ambulatorium | Sønderborg | 6400 | Denmark |
| Regionshospitalet Viborg, Kontinensklinikken | Viborg | 8800 | Denmark |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D059411 | Lower Urinary Tract Symptoms |
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |