Grouptraining for Overactive Bladder in Adults

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2011 by University of Aarhus.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
University of Aarhus
ClinicalTrials.gov Identifier:
NCT01187082
First received: August 10, 2010
Last updated: February 18, 2011
Last verified: February 2011
  Purpose

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).


Condition Intervention
Overactive Bladder
Behavioral: bladdertraining in groups
Behavioral: bladdertraining individually

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
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.

Resource links provided by NLM:


Further study details as provided by University of Aarhus:

Primary Outcome Measures:
  • urgencyepisodes [ Time Frame: after 2 month (end of study) ] [ Designated as safety issue: No ]
    with a bladderdiary episodes are counted at studystart / after 3 sessions of training and after 2 month (studyend)

  • urgeincontinence [ Time Frame: after 2 month (studyend) ] [ Designated as safety issue: No ]
    with a bladderdiary episodes are counted at studystart / after 3 sessions of training and after 2 month (studyend)

  • VAS score from ICI_OAB_Q [ Time Frame: after 2 month (studyend) ] [ Designated as safety issue: No ]
    with the ICI_OAB_Q counted before studystart / after 3 sessions/ after 2 month (studyend)


Secondary Outcome Measures:
  • voiding frequency [ Time Frame: after 2 month (studyend) ] [ Designated as safety issue: No ]
    counted from a bladder diary before studystart/ after 3 sessions of training/ after 2 month (studyend)

  • Compliance in training [ Time Frame: after 2 month (studyend) ] [ Designated as safety issue: No ]
    counted from a pocket bladder schedule at every training session (3 times)and after 2 month (studyend)

  • Adverse events [ Time Frame: after 2 month (studyend) ] [ Designated as safety issue: No ]
    asked at every training session (3 times)and after 2 month (studyend). Patients are supposed to report in if any AEs during study


Estimated Enrollment: 90
Study Start Date: December 2009
Estimated Study Completion Date: April 2011
Estimated Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01187082

Contacts
Contact: Mette Hulbaek, nurse 2214 5989 mh@klifo.dk
Contact: Kirsten Kaysen, nurse + 45 8949 6543 kirskays@rm.dk

Locations
Denmark
Glostrup Hospital Active, not recruiting
Glostrup, Denmark, 2600
Kolding Sygehus, urogynecology department Recruiting
Kolding, Denmark, 6000
Contact: Heidi Thomsen, Nurse    +45 7636 2456    'Heidi.Thomsen@slb.regionsyddanmark.dk'   
Contact: Elisabeth Benthien, Nurse    +45 7636 2456    Elisabeth.Bentien@slb.regionsyddanmark.dk   
Sønderborg Sygehus, Gynækologiske Ambulatorium Recruiting
Sønderborg, Denmark, 6400
Contact: Elisabeth Benthien, Nurse    +45 7418 2239    elisabeth.benthien@slb.regionsyddanmark.dk   
Principal Investigator: Elisabeth Benthien, Nurse         
Regionshospitalet Viborg, Kontinensklinikken Recruiting
Viborg, Denmark, 8800
Contact: Klaus Rasmussen, Nurse    +45 8927 2727    klaus.rasmussen@viborg.rm.dk   
Principal Investigator: Klaus Rasmussen, Nurse         
Århus Universitetshospital, Skejby, urogynaekology dep. Recruiting
Århus, Denmark, 8300
Contact: Kirsten Kaysen, Nurse    +45 8949 6543    kirskays@rm.dk   
Principal Investigator: Kirsten Kaysen, Nurse         
Sponsors and Collaborators
University of Aarhus
Investigators
Principal Investigator: Kirsten Kaysen, nurse Århus Universitetshospital, Skejby
  More Information

No publications provided

Responsible Party: University of Aarhus, Det Sundhedsvidenskabelige Fakultet
ClinicalTrials.gov Identifier: NCT01187082     History of Changes
Other Study ID Numbers: BLATRA 01
Study First Received: August 10, 2010
Last Updated: February 18, 2011
Health Authority: Denmark: Ethics Committee
Denmark: Danish Dataprotection Agency

Keywords provided by University of Aarhus:
overactive bladder
women
bladder training
groups

Additional relevant MeSH terms:
Urinary Bladder, Overactive
Urinary Bladder Diseases
Urologic Diseases
Urological Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on July 29, 2014