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Randomised trial with 3 months follow up.
Gynaecological practices at 2 academic health science centres in southeastern USA.
204 women ≥45 years of age (mean age 61 y, 92% white) who were living in the community, ambulatory, mentally competent, and able to toilet independently; had urine loss ≥once/week; and had urodynamic evidence of genuine stress incontinence, detrusor instability, or both. Exclusion criteria were reversible causes of urinary incontinence, uncontrolled metabolic conditions, residual urine volume after voiding >100 ml, urinary tract infection, genitourinary fistula or indwelling catheter, or inability to contract a pelvic muscle. Follow up was 95%.
Women were allocated to either bladder training (n=68), pelvic muscle exercises with biofeedback assisted instruction (n=69), or combined bladder training plus pelvic muscle exercises (n=67) for 12 weeks. All patients were educated by nurses who used positive reinforcement.
Main outcome measures
Frequency of self reported incontinence, quality of life, perceived symptom improvement, and patient satisfaction.
71% of women had genuine stress incontinence alone, 14% had detrusor instability alone, and 15% had both genuine stress incontinence and detrusor instability. Immediately after treatment. women who received combination therapy had fewer incontinent episodes (mean 6.8/wks) than those who received bladder training (mean 10.6/wks) or pelvic muscle exercises (mean 9.6/wks) (p<0.01). Compared with pelvic muscle exercises, combination therapy increased the number of patients cured of incontinence and the number with perceived symptom improvement (p⩽0.05) (table⇓); and among women with detrusor instability, lowered the impact of incontinence on life (p=0.009) and reduced symptom distress (p=0.038). No differences existed between groups at 3 months after treatment.
Immediately after treatment, women with urinary incontinence who received bladder training plus pelvic muscle exercises had fewer incontinent episodes, better quality of life, and increased perception of symptom improvement. 3 months after treatment, all interventions showed similar effects.
Few studies have evaluated the effectiveness of bladder training or pelvic muscle exercises with biofeedback, or both, for urinary incontinence. Those that have were of short term duration.1 This study by Wyman et al is valuable because it compared the treatments across urodynamic diagnoses. The important finding was that immediately after treatment, women who received combination therapy had a greater improvement in symptoms, irrespective of urodynamic diagnosis.
Mechanisms of bladder training and pelvic muscle exercises are not fully understood. These treatments have not been examined in large, long term, randomised controlled trials. This study would have benefited from the inclusion of a non-treatment control group, an independent examiner blinded to the treatment to assess the outcomes, and pad test results and post-treatment urodynamic studies to validate the findings.
Although no differences existed between the groups after 3 months, there was a positive trend towards reduced episodes of incontinence, and greater perceived improvement and patient satisfaction in the combination therapy group. There was also a much higher median improvement rate for this group, which needs further explanation.
This study supports the findings of other research that behavioural interventions do help patients to achieve positive outcomes. It did not show that specific combination therapy is the most effective over 3 months. More long term studies are required in this area.
Sources of funding: National Institute of Aging; National Institutes of Health.
For correspondence: Dr J F Wyman, School of Nursing, University of Minnesota, 6–101 Weaver-Densford Hall, 308 Harvard Street SE, Minneapolis, MN 55455, USA. Fax +1 612 626 2359.
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