Grouptraining for Overactive Bladder in Adults

Overactive Bladder Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01187082
• Other study ID #: BLATRA 01
• Status: Completed
• Phase: N/A
• First received: August 10, 2010
• Last updated: March 9, 2015
• Start date: December 2009
• Est. completion date: March 2013

Study information

• Verified date: February 2011
• Source: University of Aarhus
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Ethics CommitteeDenmark: Danish Dataprotection Agency
• Study type: Interventional

Clinical Trial 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).

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 information / eligibility

• Status: Completed
• Enrollment: 91
• Est. completion date: March 2013
• Est. primary completion date: March 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Overactive Bladder
• Urinary Bladder, Overactive

Intervention

Behavioral:
• bladdertraining 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.
• 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.

Locations

Country	Name	City	State
Denmark	Århus Universitetshospital, Skejby, urogynaekology dep.	Århus
Denmark	Glostrup Hospital	Glostrup
Denmark	Kolding Sygehus, urogynecology department	Kolding
Denmark	Sønderborg Sygehus, Gynækologiske Ambulatorium	Sønderborg
Denmark	Regionshospitalet Viborg, Kontinensklinikken	Viborg

Sponsors (1)

Lead Sponsor	Collaborator
University of Aarhus

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	No
Primary	urgeincontinence	with a bladderdiary episodes are counted at studystart / after 3 sessions of training and after 2 month (studyend)	after 2 month (studyend)	No
Primary	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)	No
Secondary	voiding frequency	counted from a bladder diary before studystart/ after 3 sessions of training/ after 2 month (studyend)	after 2 month (studyend)	No
Secondary	Compliance in training	counted from a pocket bladder schedule at every training session (3 times)and after 2 month (studyend)	after 2 month (studyend)	No
Secondary	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)	No