Effect of preoperative pelvic floor muscle therapy with biofeedback versus standard care on stress urinary incontinence and quality of life in men undergoing laparoscopic radical prostatectomy: A randomised control trial

Abstract

Laparoscopic radical prostatectomy (LARP) may cause stress urinary incontinence (SUI). This study reports the effects of preoperative pelvic floor muscle therapy (PFMT) on SUI and quality of life (QoL) in men undergoing LARP. In this single-center randomized controlled trial, 122 patients undergoing LARP were assigned to an intervention group of PFMT with biofeedback once a week preoperatively, with 4 weeks' follow-up or to a control group receiving standard care. Randomization and allocation to the trial group were carried out by a central computer system. The primary analysis was based on 121 (n = 65; n = 56), comparing SUI rates and QoL in the two groups in a 1-year follow-up. Validated questionnaires, the Pelvic Floor Inventories (PeLFls), the King's Health Questionnaire (KHQ), the International Prostate Symptom Score (IPSS), a bladder diary, a 24-hr pad test and pelvic floor examination were used. Continence was defined as no leakage at all. All analyses were performed according to intention-to-treat. One hundred twenty-two patients were randomized, 19 patients were excluded from analysis because of early drop-out. There were no significant differences between both groups in the incidence of SUI and QoL based on the KHQ, IPSS, and pad tests (P ≥ 0.05). In all patients continence was achieved in 77.2% at 1 year postoperatively. Preoperative PFMT does not appear to be effective in the prevention of SUI and QoL following LARP.