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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
Glostrup University Hospital, Copenhagen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Male focused on measuring PFMT, Stroke, LUTS, Men

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleAccepts Healthy Volunteers

Inclusion Criteria:

  1. Men, diagnosed with stroke clinical defined according World Health Organisation (WHO 1989) and confirmed by CT and MRI scan
  2. Onset of last stroke ≥ 1 month
  3. Normal cognitive function (minimal mental examination score > 25 ) (Folstein, Folstein et al. 1976).
  4. LUTS according to ICS definition (Abrams, Cardozo et al. 2002), with start or aggravation in close relation to the stroke
  5. Independent walking abilities indoor > 100 m with/without aids
  6. Independence in toilet visits
  7. Age > 18 years

Exclusion Criteria:

  1. Prior history of LUTS surgery, pelvic surgery or trauma
  2. More than 2 hospital diagnosed stroke
  3. Other severe neurological diseases including dementia
  4. Severe dysphasia
  5. Severe psychiatric disease
  6. Prostate cancer
  7. 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

First Posted
January 4, 2010
Last Updated
July 31, 2018
Sponsor
Glostrup University Hospital, Copenhagen
Collaborators
Fondation of 18.12.1981
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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

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Pelvic Floor Muscle Training(PFMT) on Lower Urinary Tract Symptoms (LUTS) in Men With Stroke

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