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NCT Number: NCT01042249

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

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

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Key information

Conditions

Male Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Congenital, Hereditary, and Neonatal Diseases and Abnormalities Endocrine Gland Neoplasms Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genetic Diseases, Inborn Lower Urinary Tract Symptoms Male Urogenital Diseases Multiple Endocrine Neoplasia Multiple Endocrine Neoplasia Type 1 Neoplasms Neoplasms by Site Neoplasms, Multiple Primary Neoplastic Syndromes, Hereditary Nervous System Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms Stroke Urinary Incontinence Urination Disorders Urogenital Diseases Urologic Diseases Urological Manifestations Vascular Diseases

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

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

Glostrup Municipality, DK-2600, Denmark

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Men, diagnosed with stroke clinical defined according World Health Organisation (WHO 1989) and confirmed by CT and MRI scan
  • Onset of last stroke ≥ 1 month
  • Normal cognitive function (minimal mental examination score > 25 ) (Folstein, Folstein et al. 1976).
  • LUTS according to ICS definition (Abrams, Cardozo et al. 2002), with start or aggravation in close relation to the stroke
  • Independent walking abilities indoor > 100 m with/without aids
  • Independence in toilet visits
  • Age > 18 years

Exclusion criteria

  • Prior history of LUTS surgery, pelvic surgery or trauma
  • More than 2 hospital diagnosed stroke
  • Other severe neurological diseases including dementia
  • Severe dysphasia
  • Severe psychiatric disease
  • Prostate cancer
  • Do not speak Danish or English

Treatment and study plan

Pelvic Floor Muscle training

Other

12 week training program including home exercises

Primary outcomes

  1. DAN-PSS-1 questionnaire

    Time frame: 2010-2012

Secondary outcomes

  1. Pelvic Floor Muscle Assessment test

    Time frame: 2010-2012

Sponsors and collaborators

Lead sponsor

Glostrup University Hospital, Copenhagen

Other

Collaborators

  • Fondation of 18.12.1981

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2017
Study completion
2017
First posted
Jan 5, 2010
Registry last updated
Aug 1, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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