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Grouptraining for Overactive Bladder in Adults

Primary Purpose

Overactive Bladder

Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
bladdertraining in groups
bladdertraining individually
Sponsored by
University of Aarhus
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Overactive Bladder focused on measuring overactive bladder, women, bladder training, groups

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Glostrup Hospital
  • Kolding Sygehus, urogynecology department
  • Sønderborg Sygehus, Gynækologiske Ambulatorium
  • Regionshospitalet Viborg, Kontinensklinikken
  • Århus Universitetshospital, Skejby, urogynaekology dep.

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

bladdertraining group

bladdertraining individually

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

voiding frequency
counted from a bladder diary before studystart/ after 3 sessions of training/ after 2 month (studyend)
Compliance in training
counted from a pocket bladder schedule at every training session (3 times)and 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

Full Information

First Posted
August 10, 2010
Last Updated
March 9, 2015
Sponsor
University of Aarhus
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1. Study Identification

Unique Protocol Identification Number
NCT01187082
Brief Title
Grouptraining for Overactive Bladder in Adults
Official 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.
Study Type
Interventional

2. Study Status

Record Verification Date
February 2011
Overall Recruitment Status
Completed
Study Start Date
December 2009 (undefined)
Primary Completion Date
March 2013 (Actual)
Study Completion Date
March 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Aarhus

4. Oversight

Data Monitoring Committee
No

5. Study Description

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).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overactive Bladder
Keywords
overactive bladder, women, bladder training, groups

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
91 (Actual)

8. Arms, Groups, and Interventions

Arm Title
bladdertraining group
Arm Type
Experimental
Arm Description
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.
Arm Title
bladdertraining individually
Arm Type
Active Comparator
Arm Description
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
Intervention Name(s)
bladdertraining in groups
Intervention Description
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
Intervention Name(s)
bladdertraining individually
Intervention Description
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 Outcome Measure Information:
Title
urgencyepisodes
Description
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)
Title
urgeincontinence
Description
with a bladderdiary episodes are counted at studystart / after 3 sessions of training and after 2 month (studyend)
Time Frame
after 2 month (studyend)
Title
VAS score from ICI_OAB_Q
Description
with the ICI_OAB_Q counted before studystart / after 3 sessions/ after 2 month (studyend)
Time Frame
after 2 month (studyend)
Secondary Outcome Measure Information:
Title
voiding frequency
Description
counted from a bladder diary before studystart/ after 3 sessions of training/ after 2 month (studyend)
Time Frame
after 2 month (studyend)
Title
Compliance in training
Description
counted from a pocket bladder schedule at every training session (3 times)and after 2 month (studyend)
Time Frame
after 2 month (studyend)
Title
Adverse events
Description
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)

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kirsten Kaysen, nurse
Organizational Affiliation
Århus Universitetshospital, Skejby
Official's Role
Principal Investigator
Facility Information:
Facility Name
Glostrup Hospital
City
Glostrup
ZIP/Postal Code
2600
Country
Denmark
Facility Name
Kolding Sygehus, urogynecology department
City
Kolding
ZIP/Postal Code
6000
Country
Denmark
Facility Name
Sønderborg Sygehus, Gynækologiske Ambulatorium
City
Sønderborg
ZIP/Postal Code
6400
Country
Denmark
Facility Name
Regionshospitalet Viborg, Kontinensklinikken
City
Viborg
ZIP/Postal Code
8800
Country
Denmark
Facility Name
Århus Universitetshospital, Skejby, urogynaekology dep.
City
Århus
ZIP/Postal Code
8300
Country
Denmark

12. IPD Sharing Statement

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Grouptraining for Overactive Bladder in Adults

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