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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
  Purpose

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 Intervention
Male
Stroke
Urinary Incontinence
Other: Pelvic Floor Muscle training

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: The Effect of Pelvic Floor Muscle Training on Lower Urinary Tract Symptoms (LUTS) in Men With Stroke

Resource links provided by NLM:


Further study details as provided by Glostrup University Hospital, Copenhagen:

Primary Outcome Measures:
  • DAN-PSS-1 questionnaire [ Time Frame: 2010-2012 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Pelvic Floor Muscle Assessment test [ Time Frame: 2010-2012 ] [ Designated as safety issue: No ]

Estimated Enrollment: 120
Study Start Date: February 2010
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01042249

Locations
Denmark
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
  More Information

No publications provided

Responsible Party: Sigrid Tibaek, pt, Dr Med Sci, Glostrup University Hospital, Copenhagen
ClinicalTrials.gov Identifier: NCT01042249     History of Changes
Other Study ID Numbers: H-B-2009-069
Study First Received: January 4, 2010
Last Updated: September 20, 2013
Health Authority: Denmark: The Danish Registry for Dataprotection

Keywords provided by Glostrup University Hospital, Copenhagen:
PFMT
Stroke
LUTS
Men

Additional relevant MeSH terms:
Cerebral Infarction
Lower Urinary Tract Symptoms
Stroke
Urinary Incontinence
Brain Diseases
Brain Infarction
Brain Ischemia
Cardiovascular Diseases
Central Nervous System Diseases
Cerebrovascular Disorders
Nervous System Diseases
Signs and Symptoms
Urination Disorders
Urologic Diseases
Urological Manifestations
Vascular Diseases

ClinicalTrials.gov processed this record on November 27, 2014