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Clinical Trials/NCT01042249
NCT01042249
Completed
Not Applicable

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

Glostrup University Hospital, Copenhagen1 site in 1 country31 target enrollmentFebruary 2010
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ConditionsMaleStrokeUrinary Incontinence

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Male
Sponsor
Glostrup University Hospital, Copenhagen
Enrollment
31
Locations
1
Primary Endpoint
DAN-PSS-1 questionnaire
Status
Completed
Last Updated
7 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

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
Registry
clinicaltrials.gov
Start Date
February 2010
End Date
April 26, 2017
Last Updated
7 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Male

Investigators

Sponsor
Glostrup University Hospital, Copenhagen
Responsible Party
Principal Investigator
Principal Investigator

Sigrid Tibaek

pt, Dr Med Sci

Glostrup University Hospital, Copenhagen

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

Outcomes

Primary Outcomes

DAN-PSS-1 questionnaire

Time Frame: 2010-2012

Secondary Outcomes

  • Pelvic Floor Muscle Assessment test(2010-2012)

Study Sites (1)

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