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Pelvic Floor Muscle Training for Incontinence in Older Women.

Primary Purpose

Stress Urinary Incontinence

Status
Completed
Phase
Not Applicable
Locations
Australia
Study Type
Interventional
Intervention
Pelvic floor muscle training and bladder training
Sponsored by
University of Melbourne
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stress Urinary Incontinence focused on measuring Stress urinary incontinence, Pelvic floor muscle training, Bladder training, Older women

Eligibility Criteria

65 Years - undefined (Older Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria: Community-dwelling women aged over 65 years urodynamically proven stress incontinence Medically stable Exclusion Criteria: Already receiving physiotherapy intervention Neurogenic incontinence Cannot comply with training program

Sites / Locations

  • Austin Health

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Pelvic floor muscle training

Bladder training

Arm Description

Weekly group session of education and exercise to music incorporating pelvic floor muscle training incorporating motor control, strength, endurance, power and functional training in a variety of different positions.

Weekly group session of education regarding deferral techniques, timed voiding parameters and gentle exercise to music.

Outcomes

Primary Outcome Measures

Quantity of urine lost over a 7-day period measured by self-report.
Self report of urine leakage
Urine lost on stress test measured by pad weigh test.
Pad weight following stress test

Secondary Outcome Measures

King's Health Questionnaire.
Quality of life questionnaire
Degree of bother
Visual Analogue Scale of degree of bother
Severity of stress incontinence
Severity of stress incontinence measured by the ICIQ-UI SF
Displacement of pelvic floor during muscle contraction
Displacement measured using transabdominal ultrasound imaging.

Full Information

First Posted
September 13, 2005
Last Updated
April 28, 2021
Sponsor
University of Melbourne
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1. Study Identification

Unique Protocol Identification Number
NCT00222248
Brief Title
Pelvic Floor Muscle Training for Incontinence in Older Women.
Official Title
The Effect of Pelvic Floor Muscle Training for the Management of Incontinence in Older Women: a Single Blind Randomised Controlled Trial.
Study Type
Interventional

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
March 3, 2003 (Actual)
Primary Completion Date
March 6, 2006 (Actual)
Study Completion Date
March 6, 2006 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Melbourne

4. Oversight

5. Study Description

Brief Summary
To determine the effect of pelvic floor muscle training in women aged 70 years and over, who have proven stress urinary incontinence. The hypotheses to be tested are: That pelvic floor muscle training is effective in relief of symptoms of stress urinary incontinence as measured by a greater reduction in the number of episodes of incontinence, quantity of urine lost and improvement of quality of life. That women who undertake pelvic floor muscle training will show greater improvement of pelvic floor muscle function than women who have behavioural (bladder) training, as measured by real time transabdominal ultrasound.
Detailed Description
Urinary incontinence is associated with significant personal stress, shame and social stigma and affects around one-third of women over 60 years of age. It restricts the amount of physical activity and can lead to social isolation and poor health. Pelvic floor muscle re-education by physiotherapists is the most commonly recommended method of conservative management. Although a recent Cochrane review concluded that it was an effective treatment for women with stress and mixed incontinence, there is still no strong evidence for the effectiveness of this intervention in elderly women. It has also been suggested that bladder training alone is equally effective in patients with stress urinary incontinence, urge and mixed incontinence. This is contrary to current clinical experience. It is therefore important to distinguish the relative effectiveness of these interventions used in isolation in order to ensure that urinary incontinence is managed in the most effective and efficient way. Comparisons: pelvic floor muscle training group and bladder training. Assessments will be conducted at baseline, 1 month, 3 months and 5 months during the intervention period. Both groups will then continue with their home program for a further 7 months until their final assessment (Assessment 5). Outcome measures will include: volume of urine lost during a stress test, completion of accident diaries, Degree of 'bother', quality of life using the Kings Health Questionnaire, and assessment of pelvic floor function using real time transabdominal diagnostic ultrasound.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stress Urinary Incontinence
Keywords
Stress urinary incontinence, Pelvic floor muscle training, Bladder training, Older women

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
83 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Pelvic floor muscle training
Arm Type
Experimental
Arm Description
Weekly group session of education and exercise to music incorporating pelvic floor muscle training incorporating motor control, strength, endurance, power and functional training in a variety of different positions.
Arm Title
Bladder training
Arm Type
Active Comparator
Arm Description
Weekly group session of education regarding deferral techniques, timed voiding parameters and gentle exercise to music.
Intervention Type
Behavioral
Intervention Name(s)
Pelvic floor muscle training and bladder training
Primary Outcome Measure Information:
Title
Quantity of urine lost over a 7-day period measured by self-report.
Description
Self report of urine leakage
Time Frame
1, 3, 5 (end of intervention) and 12 months
Title
Urine lost on stress test measured by pad weigh test.
Description
Pad weight following stress test
Time Frame
1, 3, 5 (end of intervention) and 12 months
Secondary Outcome Measure Information:
Title
King's Health Questionnaire.
Description
Quality of life questionnaire
Time Frame
1, 3, 5 (end of intervention) and 12 months
Title
Degree of bother
Description
Visual Analogue Scale of degree of bother
Time Frame
1, 3, 5 (end of intervention) and 12 months
Title
Severity of stress incontinence
Description
Severity of stress incontinence measured by the ICIQ-UI SF
Time Frame
1, 3, 5 (end of intervention) and 12 months
Title
Displacement of pelvic floor during muscle contraction
Description
Displacement measured using transabdominal ultrasound imaging.
Time Frame
1, 3, 5 (end of intervention) and 12 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Community-dwelling women aged over 65 years urodynamically proven stress incontinence Medically stable Exclusion Criteria: Already receiving physiotherapy intervention Neurogenic incontinence Cannot comply with training program
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mary P Galea, PhD
Organizational Affiliation
University of Melbourne
Official's Role
Principal Investigator
Facility Information:
Facility Name
Austin Health
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3084
Country
Australia

12. IPD Sharing Statement

Citations:
PubMed Identifier
21284022
Citation
Sherburn M, Bird M, Carey M, Bo K, Galea MP. Incontinence improves in older women after intensive pelvic floor muscle training: an assessor-blinded randomized controlled trial. Neurourol Urodyn. 2011 Mar;30(3):317-24. doi: 10.1002/nau.20968. Epub 2011 Jan 31.
Results Reference
result

Learn more about this trial

Pelvic Floor Muscle Training for Incontinence in Older Women.

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