Skip to main content
OpenTrials
Completed

NCT Number: NCT01187082

Grouptraining for Overactive Bladder in Adults

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).

Completed

Looking for future studies?

Notify Me

Key information

Conditions

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

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Århus Universitetshospital, Skejby, urogynaekology dep., Aarhus, Denmark

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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 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.

Primary outcomes

  1. urgencyepisodes

    Time frame: after 2 month (end of study)

    with a bladderdiary episodes are counted at studystart / after 3 sessions of training and after 2 month (studyend)

  2. urgeincontinence

    Time frame: after 2 month (studyend)

    with a bladderdiary episodes are counted at studystart / after 3 sessions of training and after 2 month (studyend)

  3. VAS score from ICI_OAB_Q

    Time frame: after 2 month (studyend)

    with the ICI_OAB_Q counted before studystart / after 3 sessions/ after 2 month (studyend)

Secondary outcomes

  1. voiding frequency

    Time frame: after 2 month (studyend)

    counted from a bladder diary before studystart/ after 3 sessions of training/ after 2 month (studyend)

  2. Compliance in training

    Time frame: after 2 month (studyend)

    counted from a pocket bladder schedule at every training session (3 times)and after 2 month (studyend)

  3. Adverse events

    Time frame: after 2 month (studyend)

    asked at every training session (3 times)and after 2 month (studyend). Patients are supposed to report in if any AEs during study

Sponsors and collaborators

Lead sponsor

University of Aarhus

Other

Registry information

Official study 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.

Important dates

Study start
2009
Primary completion
2013
Study completion
2013
First posted
Aug 23, 2010
Registry last updated
Mar 10, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.