Grouptraining for Overactive Bladder in Adults

NCT ID: NCT01187082

Last Updated: 2015-03-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

91 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-12-31

Study Completion Date

2013-03-31

Brief Summary

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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).

Detailed Description

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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.

Conditions

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Overactive Bladder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

bladdertraining in groups

Intervention Type 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.

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.

Group Type ACTIVE_COMPARATOR

bladdertraining individually

Intervention Type 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.

Interventions

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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.

Intervention Type 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 Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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University of Aarhus

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Kirsten Kaysen, nurse

Role: PRINCIPAL_INVESTIGATOR

Århus Universitetshospital, Skejby

Locations

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Århus Universitetshospital, Skejby, urogynaekology dep.

Aarhus, , Denmark

Site Status

Glostrup Hospital

Glostrup Municipality, , Denmark

Site Status

Kolding Sygehus, urogynecology department

Kolding, , Denmark

Site Status

Sønderborg Sygehus, Gynækologiske Ambulatorium

Sønderborg, , Denmark

Site Status

Regionshospitalet Viborg, Kontinensklinikken

Viborg, , Denmark

Site Status

Countries

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Denmark

References

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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.

Reference Type DERIVED
PMID: 37811598 (View on PubMed)

Other Identifiers

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BLATRA 01

Identifier Type: -

Identifier Source: org_study_id

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