This trial is active, not recruiting.

Conditions male, stroke, urinary incontinence
Treatment pelvic floor muscle training
Sponsor Glostrup University Hospital, Copenhagen
Collaborator Fondation of 18.12.1981
Start date February 2010
End date December 2013
Trial size 120 participants
Trial identifier NCT01042249, H-B-2009-069


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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking single blind (investigator)
Primary purpose treatment
Treated with Pelvic Floor Muscle Training in 12 weeks
pelvic floor muscle training
12 week training program including home exercises
(No Intervention)
Receives standard rehabilitation after stroke

Primary Outcomes

DAN-PSS-1 questionnaire
time frame: 2010-2012

Secondary Outcomes

Pelvic Floor Muscle Assessment test
time frame: 2010-2012

Eligibility Criteria

Male participants at least 18 years old.

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

Additional Information

Official title The Effect of Pelvic Floor Muscle Training on Lower Urinary Tract Symptoms (LUTS) in Men With Stroke
Trial information was received from ClinicalTrials.gov and was last updated in March 2015.
Information provided to ClinicalTrials.gov by Glostrup University Hospital, Copenhagen.