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

G

Glostrup University Hospital, Copenhagen

Status

Completed

Conditions

Stroke
Urinary Incontinence
Male

Treatments

Other: Pelvic Floor Muscle training

Study type

Interventional

Funder types

Other

Identifiers

NCT01042249
H-B-2009-069

Details and patient eligibility

About

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

Enrollment

31 patients

Sex

Male

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

31 participants in 2 patient groups

Treatment
Experimental group
Description:
Treated with Pelvic Floor Muscle Training in 12 weeks
Treatment:
Other: Pelvic Floor Muscle training
Control
No Intervention group
Description:
Receives standard rehabilitation after stroke

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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