Pelvic Floor Muscle Training for Incontinence in Older Women.
|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
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.
|Condition or disease||Intervention/treatment|
|Stress Urinary Incontinence||Behavioral: Pelvic floor muscle training and bladder training|
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 :||Interventional (Clinical Trial)|
|Estimated Enrollment :||90 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||The Effect of Pelvic Floor Muscle Training for the Management of Incontinence in Older Women: a Single Blind Randomised Controlled Trial.|
|Study Start Date :||March 2003|
|Estimated Study Completion Date :||March 2006|
- Quantity of urine lost over a 7-day period measured by self-report.
- Urine lost on stress test measured by pad weigh test.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00222248
|Melbourne, Victoria, Australia, 3084|
|Principal Investigator:||Mary P Galea, PhD||University of Melbourne|