Effect of Pelvic Floor Muscle Training in Stroke

Stroke Clinical Trial

Official title:

Six Months Follow-Up of Pelvic Floor Muscle Training in Women With Urinary Incontinence After Stroke

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00258037
• Other study ID #: ST-KA98117
• Status: Terminated
• Phase: Phase 2
• First received: November 23, 2005
• Last updated: May 25, 2010
• Start date: January 1999
• Est. completion date: September 2001

Study information

• Verified date: March 2000
• Source: Glostrup University Hospital, Copenhagen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Health Administration
• Study type: Interventional

Clinical Trial Summary

Aim: To evaluate the long term effect of pelvic floor muscle training in women with urinary incontinence after ischemic stroke measured by quality of life paramters.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 60
• Est. completion date: September 2001
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 40 Years to 85 Years

Eligibility

Inclusion Criteria:

• Female stroke patients

• one month since stroke

• UI in close relation to the stroke

• normal cognitive level

• independent walking indoor ability > 100 m

• independence in toilet visit

Exclusion Criteria:

• urinary ineffections

• vaginal prolabs

• qronical lung disease

• psychiatric diseases

• other neurological diseases

• do not speak Danish

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Stroke
• Urinary Incontinence

Intervention

Behavioral:
• Pelvic Floor Muscle training

Locations

Country	Name	City	State
Denmark	Copenhagen University Hospital, Glostrup	Glostrup

Sponsors (1)

Lead Sponsor	Collaborator
Glostrup University Hospital, Copenhagen

Country where clinical trial is conducted

Denmark, 

References & Publications (3)

Tibaek S, Gard G, Jensen R. Is there a long-lasting effect of pelvic floor muscle training in women with urinary incontinence after ischemic stroke? A 6-month follow-up study. Int Urogynecol J Pelvic Floor Dysfunct. 2007 Mar;18(3):281-7. Epub 2006 Jun 28. — View Citation

Tibaek S, Gard G, Jensen R. Pelvic floor muscle training is effective in women with urinary incontinence after stroke: a randomised, controlled and blinded study. Neurourol Urodyn. 2005;24(4):348-57. Erratum in: Neurourol Urodyn. 2008;27(1):100. — View Citation

Tibaek S, Jensen R, Lindskov G, Jensen M. Can quality of life be improved by pelvic floor muscle training in women with urinary incontinence after ischemic stroke? A randomised, controlled and blinded study. Int Urogynecol J Pelvic Floor Dysfunct. 2004 Ma — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quality of Life parameters (SF-36, IIQ)