Effect of Pelvic Floor Muscle Training in Stroke
May 25, 2010 updated by: Glostrup University Hospital, Copenhagen
Six Months Follow-Up of Pelvic Floor Muscle Training in Women With Urinary Incontinence After Stroke
Aim: To evaluate the long term effect of pelvic floor muscle training in women with urinary incontinence after ischemic stroke measured by quality of life paramters.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment
60
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Glostrup, Denmark, DK-2600
- Copenhagen University Hospital, Glostrup
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
40 years to 85 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- Female stroke patients
- one month since stroke
- UI in close relation to the stroke
- normal cognitive level
- independent walking indoor ability > 100 m
- independence in toilet visit
Exclusion Criteria:
- urinary ineffections
- vaginal prolabs
- qronical lung disease
- psychiatric diseases
- other neurological diseases
- do not speak Danish
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
|---|
|
Quality of Life parameters (SF-36, IIQ)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Sigrid G Tibaek, MSc., Pt, Copenhagen University Hospital, Glostrup
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Tibaek S, Jensen R, Lindskov G, Jensen M. Can quality of life be improved by pelvic floor muscle training in women with urinary incontinence after ischemic stroke? A randomised, controlled and blinded study. Int Urogynecol J Pelvic Floor Dysfunct. 2004 Mar-Apr;15(2):117-23; discussion 123. doi: 10.1007/s00192-004-1124-1. Epub 2004 Jan 31. Erratum In: Int Urogynecol J Pelvic Floor Dysfunct. 2008 Feb;19(2):311.
- Tibaek S, Gard G, Jensen R. Pelvic floor muscle training is effective in women with urinary incontinence after stroke: a randomised, controlled and blinded study. Neurourol Urodyn. 2005;24(4):348-57. doi: 10.1002/nau.20134. Erratum In: Neurourol Urodyn. 2008;27(1):100.
- Tibaek S, Gard G, Jensen R. Is there a long-lasting effect of pelvic floor muscle training in women with urinary incontinence after ischemic stroke? A 6-month follow-up study. Int Urogynecol J Pelvic Floor Dysfunct. 2007 Mar;18(3):281-7. doi: 10.1007/s00192-006-0137-3. Epub 2006 Jun 28. Erratum In: Int Urogynecol J Pelvic Floor Dysfunct. 2008 Feb;19(2):309.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 1999
Study Completion
September 1, 2001
Study Registration Dates
First Submitted
November 23, 2005
First Submitted That Met QC Criteria
November 23, 2005
First Posted (Estimate)
November 24, 2005
Study Record Updates
Last Update Posted (Estimate)
May 26, 2010
Last Update Submitted That Met QC Criteria
May 25, 2010
Last Verified
March 1, 2000
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Behavioral Symptoms
- Mental Disorders
- Cardiovascular Diseases
- Vascular Diseases
- Cerebrovascular Disorders
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Urologic Diseases
- Lower Urinary Tract Symptoms
- Urological Manifestations
- Urination Disorders
- Elimination Disorders
- Stroke
- Urinary Incontinence
- Enuresis
Other Study ID Numbers
- ST-KA98117
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.