Clinical trial NCT01187082: Grouptraining for Overactive Bladder in Adults
Official title: A Clinical, Randomized, Comparative, Non-blinded Study on the Effect of Bladdertraining in Groups Compared to Individual Bladdertraining for Female Patients With Overactive Bladder.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Overactive Bladder
Keywords: overactive bladder
women
bladder training
groups
Lead sponsor: University of Aarhus
Sponsor class: OTHER
First posted: 2010-08-23
Enrollment: 91
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility criteria: 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

Primary outcomes:
measure: urgencyepisodes
timeFrame: after 2 month (end of study)
measure: urgeincontinence
timeFrame: after 2 month (studyend)
measure: VAS score from ICI_OAB_Q
timeFrame: after 2 month (studyend)
Secondary outcomes:
measure: voiding frequency
timeFrame: after 2 month (studyend)
measure: Compliance in training
timeFrame: after 2 month (studyend)
measure: Adverse events
timeFrame: after 2 month (studyend)
Other outcomes:
Locations:
city: Glostrup
country: Denmark
facility: Glostrup Hospital
city: Kolding
country: Denmark
facility: Kolding Sygehus, urogynecology department
city: Sønderborg
country: Denmark
facility: Sønderborg Sygehus, Gynækologiske Ambulatorium
city: Viborg
country: Denmark
facility: Regionshospitalet Viborg, Kontinensklinikken
city: Århus
country: Denmark
facility: Århus Universitetshospital, Skejby, urogynaekology dep.
Study officials:
affiliation: Århus Universitetshospital, Skejby
name: Kirsten Kaysen, nurse
role: PRINCIPAL_INVESTIGATOR
References: