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

NCT ID: NCT01042249

Last Updated: 2018-08-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

31 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-02-28

Study Completion Date

2017-04-26

Brief Summary

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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

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Conditions

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Male Stroke Urinary Incontinence

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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Treatment

Treated with Pelvic Floor Muscle Training in 12 weeks

Group Type EXPERIMENTAL

Pelvic Floor Muscle training

Intervention Type OTHER

12 week training program including home exercises

Control

Receives standard rehabilitation after stroke

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Pelvic Floor Muscle training

12 week training program including home exercises

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Fondation of 18.12.1981

OTHER

Sponsor Role collaborator

Glostrup University Hospital, Copenhagen

OTHER

Sponsor Role lead

Responsible Party

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Sigrid Tibaek

pt, Dr Med Sci

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Dept. of physiotherapy and occupational therapy, Glostrup University Hospital, Copenhagen

Glostrup Municipality, , Denmark

Site Status

Countries

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Denmark

Other Identifiers

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H-B-2009-069

Identifier Type: -

Identifier Source: org_study_id

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