Efficacy of a supervised low-intensity regimen of perioperative pelvic floor muscle training in reducing postprostatectomy urinary incontinence: A randomized controlled trial

Introduction & Objectives To evaluate the efficacy of preoperative biofeedback combined with an assisted low-intensity regimen of postoperative pelvic floor muscle training (PFMT) in reducing the incidence, duration and severity of urinary incontinence in patients undergoing open radical prostatectomy (RP). Material & Methods Design: Single-center, randomized control trial. The intervention group received the day before RP a training session with biofeedback, supervised oral and written instructions on Kegel exercises and a structured program of postoperative PFMT; patients underwent control visits, including a session of biofeedback, at monthly intervals only. As standard of care, the control group received, after catheter removal, only oral and written instructions on Kegel exercises to be performed at home and underwent control visits at 1, 3 and 6 months follow-up. At each visit the number of incontinence episodes and of diapers per week and patient-reported outcome measures (ICIQ-UI, OAB-ICIQ, UCLA-PCI, IPSS-QoL) were assessed in both groups. All participants were followed-up for a period of at least six months after catheter removal. The primary outcome was the recovery of continence strictly defined as a ICIQ-UI score of zero. The differences between groups were analyzed using Fisher test and non-parametric statistics and significance threshold was set at p<0.05. The software used was GraphPad Prism 5 for Windows. Results Of 38 screened patients, 34 were eligible and 32 were available for the final analysis, 16 patients for each study group. The two groups were homogeneous for all pre, intra and postoperative relevant parameters. In the intervention group, continence has been achieved by 6 (37,5%), 8 (50%) and 10 (62,5%) patients at 1, 3 and 6 month follow-up, respectively, versus 0 (p= 0,02), 1 (6.25%; p= 0,01) and 1 (6.25%; p= 0,002) in the control group. The analysis of the UCLA-PCI and ICIQ-OAB scores, the number of incontinence episodes and of diapers per week showed statistically significant differences in favor of patients in the intervention group at 3 and 6 months. Patients in the intervention group reported better IPSS-QoL scores at all follow-up time but the difference did not reach the statistical significance. Conclusions Preoperative biofeedback combined with our supervised, low-intensity regimen of PFMT is a treatment strategy significantly more effective, but not excessively time-consuming, than usual care in improving recovery of continence in patients undergoing RP. The impact on QoL appeared less evident, although a trend for a better QoL was observed in the intervention group.