Grouptraining for Overactive Bladder in Adults

A Clinical, Randomized, Comparative, Non-blinded Study on the Effect of Bladdertraining in Groups Compared to Individual Bladdertraining for Female Patients With Overactive Bladder.

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).

Study Overview

• Status: Completed
• Conditions: Overactive Bladder
• Intervention / Treatment: Behavioral: bladdertraining in groups; Behavioral: bladdertraining individually

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.

• Study Type: Interventional
• Enrollment (Actual): 91
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Glostrup, Denmark, 2600
    • Glostrup Hospital
  • Kolding, Denmark, 6000
    • Kolding Sygehus, urogynecology department
  • Sønderborg, Denmark, 6400
    • Sønderborg Sygehus, Gynækologiske Ambulatorium
  • Viborg, Denmark, 8800
    • Regionshospitalet Viborg, Kontinensklinikken
  • Århus, Denmark, 8300
    • Århus Universitetshospital, Skejby, urogynaekology dep.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	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.
Active Comparator: 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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)

Secondary Outcome Measures

Outcome Measure	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)	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)

Collaborators and Investigators

• Sponsor: University of Aarhus
• Investigators: Principal Investigator: Kirsten Kaysen, nurse, Arhus Universitetshospital, Skejby

Study record dates

Study Major Dates

• Study Start: December 1, 2009
• Primary Completion (Actual): March 1, 2013
• Study Completion (Actual): March 1, 2013

Study Registration Dates

• First Submitted: August 10, 2010
• First Submitted That Met QC Criteria: August 20, 2010
• First Posted (Estimate): August 23, 2010

Study Record Updates

• Last Update Posted (Estimate): March 10, 2015
• Last Update Submitted That Met QC Criteria: March 9, 2015
• Last Verified: February 1, 2011

More Information

Terms related to this study

• Keywords: overactive bladder; women; bladder training; groups
• Additional Relevant MeSH Terms: Urologic Diseases; Urinary Bladder Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Urinary Bladder, Overactive
• Other Study ID Numbers: BLATRA 01