Overview

This trial is active, not recruiting.

Condition stress urinary incontinence
Treatment pelvic floor muscle training and bladder training
Sponsor University of Melbourne
Start date March 2003
End date March 2006
Trial size 90 participants
Trial identifier NCT00222248, 251632

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking single blind
Primary purpose treatment

Primary Outcomes

Measure
Quantity of urine lost over a 7-day period measured by self-report.
time frame:
Urine lost on stress test measured by pad weigh test.
time frame:

Secondary Outcomes

Measure
Quality of life using King's Health Questionnaire.
time frame:
Degree of bother using a VAS.
time frame:
Severity of stress incontinence using the ICIQ-SF.
time frame:
Displacement of pelvic floor during muscle contraction measured using transabdominal ultrasound imaging.
time frame:

Eligibility Criteria

Female participants at least 65 years old.

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

Additional Information

Official title The Effect of Pelvic Floor Muscle Training for the Management of Incontinence in Older Women: a Single Blind Randomised Controlled Trial.
Principal investigator Mary P Galea, PhD
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.
Trial information was received from ClinicalTrials.gov and was last updated in August 2006.
Information provided to ClinicalTrials.gov by University of Melbourne.