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
Recruitment status was Recruiting
Sponsor:
University of Aarhus
Information provided by:
University of Aarhus
ClinicalTrials.gov Identifier:
NCT01187082
First received: August 10, 2010
Last updated: February 18, 2011
Last verified: February 2011
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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. |
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
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 May 23, 2013