NCT00258037

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P50-P75 for phase_2 stroke

Timeline
Completed

Started Jan 1999

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 1999

Completed
2.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2001

Completed
4.2 years until next milestone

First Submitted

Initial submission to the registry

November 23, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 24, 2005

Completed
Last Updated

May 26, 2010

Status Verified

March 1, 2000

First QC Date

November 23, 2005

Last Update Submit

May 25, 2010

Conditions

StrokeUrinary Incontinence

Keywords

PhysiotherapyStrokeUrinary Incontinencequality of Life

Outcome Measures

Primary Outcomes (1)

  • Quality of Life parameters (SF-36, IIQ)

Interventions

Pelvic Floor Muscle trainingBEHAVIORAL

Eligibility Criteria

Age40 Years - 85 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • urinary ineffections
  • vaginal prolabs
  • qronical lung disease
  • psychiatric diseases
  • other neurological diseases
  • do not speak Danish

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Copenhagen University Hospital, Glostrup

Glostrup Municipality, DK-2600, Denmark

Location

Related Publications (3)

  • 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.

    PMID: 15014939RESULT

  • 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.

    PMID: 15791633RESULT

  • 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.

    PMID: 16673051RESULT

MeSH Terms

Conditions

StrokeUrinary Incontinence

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesUrination DisordersUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesLower Urinary Tract SymptomsUrological ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Sigrid G Tibaek, MSc., Pt

    Glostrup University Hospital, Copenhagen

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 23, 2005

First Posted

November 24, 2005

Study Start

January 1, 1999

Study Completion

September 1, 2001

Last Updated

May 26, 2010

Record last verified: 2000-03

Locations

DK(1)