A randomized controlled trial of the effectiveness of pelvic floor therapies for urodynamic stress and mixed incontinence

OBJECTIVES To assess the efficacy and cost-effectiveness of pelvic floor muscle therapies (PFMT) in women aged >= 40 years with urodynamic stress incontinence (USI) and mixed UI. PATIENTS AND METHODS In a three-arm randomized controlled trial in Leicestershire and Rutland UK, 238 community-dwelling women aged >= 40 years with USI in whom previous primary behavioural intervention had failed were randomized to receive either intensive PFMT (79), vaginal cone therapy (80) or to continue with primary behavioural intervention (79) for 3 months. The main outcome measure was the frequency of primary UI episodes, and secondary measures were pad-test urine loss, patient perception of problem, assessment of PF function, voiding frequency, and pad usage. Validated scales for urinary dysfunction, and impact on quality of life and satisfaction were collected at an independent interview. RESULTS All three groups had a moderate reduction in UI episodes after intervention but there was no statistically significant difference among the groups. There were marginal improvements in voiding frequency for all groups, with no statistically significant difference among them. CONCLUSIONS In women who have already had simple behavioural therapies (including advice on PFM exercises) for urinary dysfunction, the continuation of these behavioural therapies can lead to further improvement. The addition of vaginal cone therapy or intensive PFMT does not seem to contribute to further improvement. The improvement in pelvic floor function was significantly greater in the PFMT arm than in the control arm although this did not translate into changes in urinary symptoms.