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Pelvic Floor Muscle Training for Incontinence in Older Women.

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ClinicalTrials.gov Identifier: NCT00222248
Recruitment Status : Unknown
Verified June 2003 by University of Melbourne.
Recruitment status was:  Active, not recruiting
First Posted : September 22, 2005
Last Update Posted : August 8, 2006
Sponsor:
Information provided by:
University of Melbourne

Tracking Information
First Submitted Date  ICMJE September 13, 2005
First Posted Date  ICMJE September 22, 2005
Last Update Posted Date August 8, 2006
Study Start Date  ICMJE March 2003
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: September 13, 2005)
  • Quantity of urine lost over a 7-day period measured by self-report.
  • Urine lost on stress test measured by pad weigh test.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 13, 2005)
  • Quality of life using King's Health Questionnaire.
  • Degree of bother using a VAS.
  • Severity of stress incontinence using the ICIQ-SF.
  • Displacement of pelvic floor during muscle contraction measured using transabdominal ultrasound imaging.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Pelvic Floor Muscle Training for Incontinence in Older Women.
Official Title  ICMJE The Effect of Pelvic Floor Muscle Training for the Management of Incontinence in Older Women: a Single Blind Randomised Controlled Trial.
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:

  1. 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.
  2. 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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single
Primary Purpose: Treatment
Condition  ICMJE Stress Urinary Incontinence
Intervention  ICMJE Behavioral: Pelvic floor muscle training and bladder training
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Enrollment  ICMJE
 (submitted: September 13, 2005)
90
Original Enrollment  ICMJE Same as current
Study Completion Date  ICMJE March 2006
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 65 Years and older   (Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00222248
Other Study ID Numbers  ICMJE 251632
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE University of Melbourne
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Mary P Galea, PhD University of Melbourne
PRS Account University of Melbourne
Verification Date June 2003

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP