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CompletedNCT01187082Updated Mar 10, 2015

Grouptraining for Overactive Bladder in Adults

An interventional study of bladdertraining in groups and bladdertraining individually in Overactive Bladder, sponsored by University of Aarhus. Completed at 5 sites in Denmark. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-03-10.

Sponsored by University of Aarhus · Not applicable, Interventional, and Health services research

Phase
Not applicable
Study type
Interventional
Enrollment
91
Allocation
Randomized
Ages
18 Years and older
Sex
Female
01

Study 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).

Read the 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.

02

Conditions studied

  • Overactive Bladder

Keywords

  • overactive bladder
  • women
  • bladder training
  • groups
03

In context

Urinary Bladder, Overactive

855 studies on the registry are indexed under Urinary Bladder, Overactive; 125 are open to participants now.

This study's enrollment of 91 is above the median of 72 across 652 interventional studies indexed under Urinary Bladder, Overactive.

Browse Urinary Bladder, Overactive studies →

Lead sponsor

University of Aarhus is the lead sponsor of 1,274 studies on the registry; 183 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

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
05

Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
91 participants (actual)

Study arms

  • 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

  • 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

Interventions

  • Behavioralbladdertraining 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.

  • Behavioralbladdertraining 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.

06

What researchers measure

Primary outcomes

  1. urgencyepisodes

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

    Time frame: after 2 month (end of study)

  2. urgeincontinence

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

    Time frame: after 2 month (studyend)

  3. VAS score from ICI_OAB_Q

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

    Time frame: after 2 month (studyend)

Secondary outcomes

  1. voiding frequency

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

    Time frame: after 2 month (studyend)

  2. Compliance in training

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

    Time frame: after 2 month (studyend)

  3. 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

    Time frame: after 2 month (studyend)

07

Study locations

5 sites
  • Glostrup Hospital
    Glostrup, 2600, Denmark
  • Kolding Sygehus, urogynecology department
    Kolding, 6000, Denmark
  • Sønderborg Sygehus, Gynækologiske Ambulatorium
    Sønderborg, 6400, Denmark
  • Regionshospitalet Viborg, Kontinensklinikken
    Viborg, 8800, Denmark
  • Århus Universitetshospital, Skejby, urogynaekology dep.
    Århus, 8300, Denmark
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 10, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01187082
Lead sponsor
University of Aarhus
Responsible party
Sponsor
First posted
Aug 23, 2010
Start date
Dec 2009
Primary completion
Mar 2013
Completion
Mar 2013
Last update
Mar 10, 2015

Study contacts

Kirsten Kaysen, nurse
principal investigator · Århus Universitetshospital, Skejby

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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