Pelvic Floor Muscle Training(PFMT) on Lower Urinary Tract Symptoms (LUTS) in Men With Stroke
Primary Purpose
Male, Stroke, Urinary Incontinence
Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Pelvic Floor Muscle training
Sponsored by
About this trial
This is an interventional treatment trial for Male focused on measuring PFMT, Stroke, LUTS, Men
Eligibility Criteria
Inclusion Criteria:
- Men, diagnosed with stroke clinical defined according World Health Organisation (WHO 1989) and confirmed by CT and MRI scan
- Onset of last stroke ≥ 1 month
- Normal cognitive function (minimal mental examination score > 25 ) (Folstein, Folstein et al. 1976).
- LUTS according to ICS definition (Abrams, Cardozo et al. 2002), with start or aggravation in close relation to the stroke
- Independent walking abilities indoor > 100 m with/without aids
- Independence in toilet visits
- Age > 18 years
Exclusion Criteria:
- Prior history of LUTS surgery, pelvic surgery or trauma
- More than 2 hospital diagnosed stroke
- Other severe neurological diseases including dementia
- Severe dysphasia
- Severe psychiatric disease
- Prostate cancer
- Do not speak Danish or English
Sites / Locations
- Dept. of physiotherapy and occupational therapy, Glostrup University Hospital, Copenhagen
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Treatment
Control
Arm Description
Treated with Pelvic Floor Muscle Training in 12 weeks
Receives standard rehabilitation after stroke
Outcomes
Primary Outcome Measures
DAN-PSS-1 questionnaire
Secondary Outcome Measures
Pelvic Floor Muscle Assessment test
Full Information
NCT ID
NCT01042249
First Posted
January 4, 2010
Last Updated
July 31, 2018
Sponsor
Glostrup University Hospital, Copenhagen
Collaborators
Fondation of 18.12.1981
1. Study Identification
Unique Protocol Identification Number
NCT01042249
Brief Title
Pelvic Floor Muscle Training(PFMT) on Lower Urinary Tract Symptoms (LUTS) in Men With Stroke
Official Title
The Effect of Pelvic Floor Muscle Training on Lower Urinary Tract Symptoms (LUTS) in Men With Stroke
Study Type
Interventional
2. Study Status
Record Verification Date
July 2018
Overall Recruitment Status
Completed
Study Start Date
February 2010 (undefined)
Primary Completion Date
April 26, 2017 (Actual)
Study Completion Date
April 26, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Glostrup University Hospital, Copenhagen
Collaborators
Fondation of 18.12.1981
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The aim of this study is to evaluate the effect of pelvic floor muscle training (PFMT) on Lower Urinary Tract Symptoms (LUTS) in men after stroke.
120 men with LUTS or increased LUTS after stroke is included and randomized into a treatment group or a control group. The subjects in the treatment group follows a 12 week standard PFMT program, while the control group is not given specific treatment of their LUTS but like the treatment group follows the standard rehabilitation program for stroke patient. Outcome are measured by
5 questionnaires
Voiding diary
24-hour pad test
pelvic floor muscle assessment test
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Male, Stroke, Urinary Incontinence
Keywords
PFMT, Stroke, LUTS, Men
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
31 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Treatment
Arm Type
Experimental
Arm Description
Treated with Pelvic Floor Muscle Training in 12 weeks
Arm Title
Control
Arm Type
No Intervention
Arm Description
Receives standard rehabilitation after stroke
Intervention Type
Other
Intervention Name(s)
Pelvic Floor Muscle training
Intervention Description
12 week training program including home exercises
Primary Outcome Measure Information:
Title
DAN-PSS-1 questionnaire
Time Frame
2010-2012
Secondary Outcome Measure Information:
Title
Pelvic Floor Muscle Assessment test
Time Frame
2010-2012
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Men, diagnosed with stroke clinical defined according World Health Organisation (WHO 1989) and confirmed by CT and MRI scan
Onset of last stroke ≥ 1 month
Normal cognitive function (minimal mental examination score > 25 ) (Folstein, Folstein et al. 1976).
LUTS according to ICS definition (Abrams, Cardozo et al. 2002), with start or aggravation in close relation to the stroke
Independent walking abilities indoor > 100 m with/without aids
Independence in toilet visits
Age > 18 years
Exclusion Criteria:
Prior history of LUTS surgery, pelvic surgery or trauma
More than 2 hospital diagnosed stroke
Other severe neurological diseases including dementia
Severe dysphasia
Severe psychiatric disease
Prostate cancer
Do not speak Danish or English
Facility Information:
Facility Name
Dept. of physiotherapy and occupational therapy, Glostrup University Hospital, Copenhagen
City
Glostrup
ZIP/Postal Code
DK-2600
Country
Denmark
12. IPD Sharing Statement
Learn more about this trial
Pelvic Floor Muscle Training(PFMT) on Lower Urinary Tract Symptoms (LUTS) in Men With Stroke
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