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Effect of Pelvic Floor Muscle Training in Stroke

Primary Purpose

Stroke, Urinary Incontinence

Status
Terminated
Phase
Phase 2
Locations
Denmark
Study Type
Interventional
Intervention
Pelvic Floor Muscle training
Sponsored by
Glostrup University Hospital, Copenhagen
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring Physiotherapy, Stroke, Urinary Incontinence, quality of Life

Eligibility Criteria

40 Years - 85 Years (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Copenhagen University Hospital, Glostrup

Outcomes

Primary Outcome Measures

Quality of Life parameters (SF-36, IIQ)

Secondary Outcome Measures

Full Information

First Posted
November 23, 2005
Last Updated
May 25, 2010
Sponsor
Glostrup University Hospital, Copenhagen
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1. Study Identification

Unique Protocol Identification Number
NCT00258037
Brief Title
Effect of Pelvic Floor Muscle Training in Stroke
Official Title
Six Months Follow-Up of Pelvic Floor Muscle Training in Women With Urinary Incontinence After Stroke
Study Type
Interventional

2. Study Status

Record Verification Date
March 2000
Overall Recruitment Status
Terminated
Study Start Date
January 1999 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
September 2001 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Glostrup University Hospital, Copenhagen

4. Oversight

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Urinary Incontinence
Keywords
Physiotherapy, Stroke, Urinary Incontinence, quality of Life

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Single
Allocation
Randomized
Enrollment
60 (false)

8. Arms, Groups, and Interventions

Intervention Type
Behavioral
Intervention Name(s)
Pelvic Floor Muscle training
Primary Outcome Measure Information:
Title
Quality of Life parameters (SF-36, IIQ)

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sigrid G Tibaek, MSc., Pt
Organizational Affiliation
Copenhagen University Hospital, Glostrup
Official's Role
Principal Investigator
Facility Information:
Facility Name
Copenhagen University Hospital, Glostrup
City
Glostrup
ZIP/Postal Code
DK-2600
Country
Denmark

12. IPD Sharing Statement

Citations:
PubMed Identifier
15014939
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 Mar-Apr;15(2):117-23; discussion 123. doi: 10.1007/s00192-004-1124-1. Epub 2004 Jan 31. Erratum In: Int Urogynecol J Pelvic Floor Dysfunct. 2008 Feb;19(2):311.
Results Reference
result
PubMed Identifier
15791633
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. doi: 10.1002/nau.20134. Erratum In: Neurourol Urodyn. 2008;27(1):100.
Results Reference
result
PubMed Identifier
16673051
Citation
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. doi: 10.1007/s00192-006-0137-3. Epub 2006 Jun 28. Erratum In: Int Urogynecol J Pelvic Floor Dysfunct. 2008 Feb;19(2):309.
Results Reference
result

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Effect of Pelvic Floor Muscle Training in Stroke

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