Pelvic floor muscle training for the management of urinary incontinence in elderly women: a randomised controlled trial

Investigators: Ms Margaret Sherburn, Prof Mary Galea, Dr Marcus Carey, Dr Margaret Bird, Prof Kari Bø.

Urinary incontinence affects women more than men and is associated with significant personal stress, shame and social stigma. A recent Cochrane review (Hay-Smith et al. 2001) concluded that pelvic floor muscle training was an effective treatment for women with stress and mixed incontinence. All but two of the studies in this review investigated pelvic floor muscle training in groups of women with a wide range of ages. Thus there is still no strong evidence for the effectiveness of this intervention in elderly women.

However, recently published studies from two influential groups (Wyman et al. 1998, Diokno et al 2004) have 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.  

The aim of this project is to determine the effect of pelvic floor muscle training in women aged 65 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.

The study is a single blind randomized controlled clinical trial involving healthy elderly women with stress urinary incontinence which will have been diagnosed by urodynamic studies. Subjects are being recruited through the Continence Service at Austin Health, and the Royal Woman's Hospital Urogynaecology Clinic, by medical referral and self-referred from newspaper advertisements.

Subjects are being randomized into either the pelvic floor muscle training group or a bladder training group. Subjects in the pelvic floor muscle training group receive an individual one hour-long session in week 1, which includes pelvic floor muscle assessment by vaginal palpation, the teaching of pelvic floor muscle exercises, education regarding use of pelvic floor muscle bracing during functional activities and a home exercise program, which is recorded by subjects in a diary. Subjects then continue training in a group situation, attending weekly for a 5-month period.   Subjects assigned to the bladder training group also receive an individual one hour-long session that includes subjective symptom assessment, education regarding normal bladder control, skin care, pad usage, fluid intake, and voiding deferral techniques. The protocol followed is that recommended by Wyman et al (1998). Subjects are taught methods to control urgency, such as distraction and relaxation techniques. Self-monitoring of voiding behaviour using a voiding diary is encouraged.

Outcome measures include:

• Volume of urine lost during a stress test .
• Degree of 'bother' :
• Number of leakage episodes .
• Quality of life using the Assessment of Quality of Life (AQoL) and the King's Health Questionnaire.
• Assessment of pelvic floor function using real time transabdominal diagnostic ultrasound. This includes a measurement of (i) maximum pelvic floor excursion (ii) muscle endurance measured by the decay in sustaining an isometric contraction of the pelvic floor and time the contraction is maintained and (iii) muscle coordination as measured by variability in the excursion of the pelvic floor contraction.
• Adherence to exercise program .

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