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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Fondation of 18.12.1981
Information provided by (Responsible Party):
Sigrid Tibaek, Glostrup University Hospital, Copenhagen
ClinicalTrials.gov Identifier:
NCT01042249
First received: January 4, 2010
Last updated: September 20, 2013
Last verified: September 2013

January 4, 2010
September 20, 2013
February 2010
December 2013   (final data collection date for primary outcome measure)
DAN-PSS-1 questionnaire [ Time Frame: 2010-2012 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01042249 on ClinicalTrials.gov Archive Site
Pelvic Floor Muscle Assessment test [ Time Frame: 2010-2012 ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Pelvic Floor Muscle Training(PFMT) on Lower Urinary Tract Symptoms (LUTS) in Men With Stroke
The Effect of Pelvic Floor Muscle Training on Lower Urinary Tract Symptoms (LUTS) in Men With Stroke

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
Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
  • Male
  • Stroke
  • Urinary Incontinence
Other: Pelvic Floor Muscle training
12 week training program including home exercises
  • Experimental: Treatment
    Treated with Pelvic Floor Muscle Training in 12 weeks
    Intervention: Other: Pelvic Floor Muscle training
  • No Intervention: Control
    Receives standard rehabilitation after stroke
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
120
December 2015
December 2013   (final data collection date for primary outcome measure)

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
Male
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
Denmark
 
NCT01042249
H-B-2009-069
Yes
Sigrid Tibaek, Glostrup University Hospital, Copenhagen
Glostrup University Hospital, Copenhagen
Fondation of 18.12.1981
Not Provided
Glostrup University Hospital, Copenhagen
September 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP