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

Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01042249
• Other study ID #: H-B-2009-069
• Status: Completed
• Phase: N/A
• Start date: February 2010
• Est. completion date: April 26, 2017

Study information

• Verified date: July 2018
• Source: Glostrup University Hospital, Copenhagen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: April 26, 2017
• Est. primary completion date: April 26, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Enuresis
• Lower Urinary Tract Symptoms
• Male
• Stroke
• Urinary Incontinence

Intervention

Other:
• Pelvic Floor Muscle training
12 week training program including home exercises

Locations

Country	Name	City	State
Denmark	Dept. of physiotherapy and occupational therapy, Glostrup University Hospital, Copenhagen	Glostrup

Sponsors (2)

Lead Sponsor	Collaborator
Glostrup University Hospital, Copenhagen	Fondation of 18.12.1981

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	DAN-PSS-1 questionnaire		2010-2012
Secondary	Pelvic Floor Muscle Assessment test		2010-2012