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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01042249
Recruitment Status : Unknown
Verified March 2015 by Sigrid Tibaek, Glostrup University Hospital, Copenhagen.
Recruitment status was:  Active, not recruiting
First Posted : January 5, 2010
Last Update Posted : March 11, 2015
Fondation of 18.12.1981
Information provided by (Responsible Party):
Sigrid Tibaek, Glostrup University Hospital, Copenhagen

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

Condition or disease Intervention/treatment Phase
Male Stroke Urinary Incontinence Other: Pelvic Floor Muscle training Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: The Effect of Pelvic Floor Muscle Training on Lower Urinary Tract Symptoms (LUTS) in Men With Stroke
Study Start Date : February 2010
Actual Primary Completion Date : December 2013
Estimated Study Completion Date : December 2015

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Treatment
Treated with Pelvic Floor Muscle Training in 12 weeks
Other: Pelvic Floor Muscle training
12 week training program including home exercises

No Intervention: Control
Receives standard rehabilitation after stroke

Primary Outcome Measures :
  1. DAN-PSS-1 questionnaire [ Time Frame: 2010-2012 ]

Secondary Outcome Measures :
  1. Pelvic Floor Muscle Assessment test [ Time Frame: 2010-2012 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01042249

Dept. of physiotherapy and occupational therapy, Glostrup University Hospital, Copenhagen
Glostrup, Denmark, DK-2600
Sponsors and Collaborators
Glostrup University Hospital, Copenhagen
Fondation of 18.12.1981

Responsible Party: Sigrid Tibaek, pt, Dr Med Sci, Glostrup University Hospital, Copenhagen Identifier: NCT01042249     History of Changes
Other Study ID Numbers: H-B-2009-069
First Posted: January 5, 2010    Key Record Dates
Last Update Posted: March 11, 2015
Last Verified: March 2015

Keywords provided by Sigrid Tibaek, Glostrup University Hospital, Copenhagen:

Additional relevant MeSH terms:
Urinary Incontinence
Lower Urinary Tract Symptoms
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Urination Disorders
Urologic Diseases
Urological Manifestations
Signs and Symptoms
Behavioral Symptoms
Elimination Disorders
Mental Disorders