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

Not Applicable

Completed

• Conditions: Male; Stroke; Urinary Incontinence
• Interventions: Other: Pelvic Floor Muscle training

• Registration Number: NCT01042249
• Lead Sponsor: 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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-01-04
• Study First Submitted QC: 2010-01-04
• Study First Posted: 2010-01-05
• Study Start: 2010-02
• Primary Completion: 2017-04-26
• Study Completion: 2017-04-26
• Status Verified: 2018-07
• Last Update Submitted: 2018-07-31
• Last Update Posted: 2018-08-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 31

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment	Pelvic Floor Muscle training	Treated with Pelvic Floor Muscle Training in 12 weeks

Primary Outcome Measures

Name	Time	Method
DAN-PSS-1 questionnaire	2010-2012

Secondary Outcome Measures

Name	Time	Method
Pelvic Floor Muscle Assessment test	2010-2012

Trial Locations

Locations (1)

Dept. of physiotherapy and occupational therapy, Glostrup University Hospital, Copenhagen; 🇩🇰 Glostrup, Denmark