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Completed

NCT Number: NCT00222248

Pelvic Floor Muscle Training for Incontinence in Older Women.

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Pelvic floor muscle training and bladder training

Behavioral

Primary outcomes

  1. Quantity of urine lost over a 7-day period measured by self-report.

    Time frame: 1, 3, 5 (end of intervention) and 12 months

    Self report of urine leakage

  2. Urine lost on stress test measured by pad weigh test.

    Time frame: 1, 3, 5 (end of intervention) and 12 months

    Pad weight following stress test

Secondary outcomes

  1. King's Health Questionnaire.

    Time frame: 1, 3, 5 (end of intervention) and 12 months

    Quality of life questionnaire

  2. Degree of bother

    Time frame: 1, 3, 5 (end of intervention) and 12 months

    Visual Analogue Scale of degree of bother

  3. Severity of stress incontinence

    Time frame: 1, 3, 5 (end of intervention) and 12 months

    Severity of stress incontinence measured by the ICIQ-UI SF

  4. Displacement of pelvic floor during muscle contraction

    Time frame: 1, 3, 5 (end of intervention) and 12 months

    Displacement measured using transabdominal ultrasound imaging.

Sponsors and collaborators

Lead sponsor

University of Melbourne

Other

Registry information

Official study title

The Effect of Pelvic Floor Muscle Training for the Management of Incontinence in Older Women: a Single Blind Randomised Controlled Trial.

Important dates

Study start
2003
Primary completion
2006
Study completion
2006
First posted
Sep 22, 2005
Registry last updated
May 3, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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