Grouptraining for Overactive Bladder in Adults

NCT01187082 | Completed

• 1 other identifier: BLATRA 01
• Study Type: interventional
• Target: 91
• Locations: 1 country
• Sites: 5

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).

Conditions

Overactive Bladder

Keywords

overactive bladder; women; bladder training; groups

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (3)

• voiding frequency

  after 2 month (studyend)

• Compliance in training

  after 2 month (studyend)

• Adverse events

  after 2 month (studyend)

Study Arms (2)

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.

Behavioral: bladdertraining in groups

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.

Behavioral: bladdertraining individually

Interventions

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.

bladdertraining group

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.

bladdertraining individually

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• women at the age of 18 and more
• patients with overactive bladder

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Aarhus: lead

Study Sites (5)

Århus Universitetshospital, Skejby, urogynaekology dep.

Aarhus, 8300, Denmark

Location

Glostrup Hospital

Glostrup Municipality, 2600, Denmark

Location

Kolding Sygehus, urogynecology department

Kolding, 6000, Denmark

Location

Sønderborg Sygehus, Gynækologiske Ambulatorium

Sønderborg, 6400, Denmark

Location

Regionshospitalet Viborg, Kontinensklinikken

Viborg, 8800, Denmark

Location

Related Publications (1)

• 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.

  PMID: 37811598 DERIVED

MeSH Terms

Conditions

Urinary Bladder, Overactive

Interventions

Population Groups

Condition Hierarchy (Ancestors)

Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Demography; Population Characteristics

Study Officials

• Kirsten Kaysen, nurse

  Århus Universitetshospital, Skejby

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 10, 2010
• First Posted: August 23, 2010
• Study Start: December 1, 2009
• Primary Completion: March 1, 2013
• Study Completion: March 1, 2013
• Last Updated: March 10, 2015

Record last verified: 2011-02

Locations

DK (5)