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

NCT01042249 | Completed DMC

• 1 other identifier: H-B-2009-069
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

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

Conditions

Male; Stroke; Urinary Incontinence

Keywords

PFMT; Stroke; LUTS; Men

Outcome Measures

Primary Outcomes (1)

• DAN-PSS-1 questionnaire

  2010-2012

Secondary Outcomes (1)

• Pelvic Floor Muscle Assessment test

  2010-2012

Study Arms (2)

Treatment

EXPERIMENTAL

Treated with Pelvic Floor Muscle Training in 12 weeks

Other: Pelvic Floor Muscle training

Control

NO INTERVENTION

Receives standard rehabilitation after stroke

Interventions

Pelvic Floor Muscle training OTHER

12 week training program including home exercises

Treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Glostrup University Hospital, Copenhagen: lead
• Fondation of 18.12.1981: collaborator

Study Sites (1)

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

Glostrup Municipality, DK-2600, Denmark

Location

MeSH Terms

Conditions

Stroke; Urinary Incontinence; Multiple Endocrine Neoplasia Type 1

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: pt, Dr Med Sci

Study Record Dates

• First Submitted: January 4, 2010
• First Posted: January 5, 2010
• Study Start: February 1, 2010
• Primary Completion: April 26, 2017
• Study Completion: April 26, 2017
• Last Updated: August 1, 2018

Record last verified: 2018-07

Locations

DK (1)