A PILOT RANDOMIZED TRIAL OF PREOPERATIVE PELVIC FLOOR MUSCLE EXERCISE VS USUAL CARE TO IMPROVE SEXUAL FUNCTION AND HEALTH RELATED QUALITY OF LIVE AFTER RARP: PRELIMINARY DISAPPOINTED RESULTS

INTRODUCTION AND AIM OF THE STUDY Radical prostatectomy represents the most common and effective treatment for localised prostate cancer. Recently, robot-assisted radical prostatectomy (RARP) has become increasingly used worldwide. Although a recent systematic review and metaanalysis found that RARP had higher postoperative continence rates than retropubic or laparoscopic radical prostatectomy, urinary incontinence (UI) and sexual dysfunction remain themost bothersome postoperative complications even afterRARP. Pelvic floor muscle training (PFMT) may represent a valid treatment to improve sexual function. The aim of this study was to carry out a randomised controlled trial in order to determine a causal relationship between preoperative PFMT and postoperative functional outcomes in patients undergoing RARP. MATERIALS AND METHODS It was a double-arm, single- centre, pilot randomized control trial conducted at an academic teaching hospital; men undergoing RARP for prostate cancer with no contraindications to PFMT was consecutively recruited and randomized to a pre- and post-operative PFMT program or usual care. PFMT participants were engaged in a PFMT program. The PFMT prescription began with instructions on how to engage the pelvic floor delivered by the research coordinator trained in PFMT. Usual care participants did not receive any formal training in PFMT neither preoperatively nor after surgery. Estimates of intervention efficacy was captured through measurements at baseline (4–8 weeks preoperatively), within 1 week prior to surgery, and postoperatively at 4, 12, and 26 weeks. Health related Quality of life (HR-QoL) was measured using the Short-Form 36 (SF- 36) validated in Italian language. Additional urological symptoms were assessed using the valid and reliable, 7-item International Prostate Symptom Score (IPSS) with its further item on QoL. Erectile function will be assessed using the 5- item International Index of Erectile Function (IIEF) scale. RESULTS From March 2017 to September 2017, 36 patients, satisfying inclusion and exclusion criteria, were consecutively enrolled and randomized. After randomization, 22 entered PFMT arm and 14 the UC arm. Concerning HR-QoL, 4 weeks after surgery, aworsening was observed compared to the baseline in the following aspects: IIEF-5 (19.85 vs 3.73, p = 0.000), IPSS- 7 (5.29 vs 9.71, p = 0.004), IPSS-QoL (1.29 vs 3.76, p = 0.000), general health (93,42 vs 76.05, p = 0.000), role physical functioning (92.89 vs 72.21, p = 0.023), role emotional functioning (92.63 vs 75.89, p = 0.044). At 12 weeks, we observed an improvement in all aspects analysed although maintaining significant worse scores compared to the baseline as follows: IIEF-5 (507, p = 0.000) and global health (82.29, p = 0,000). In contrast we observed better body pain scores compared to baseline (70.53) both at 4 (86.37, p = 0.01) and 12 weeks (89.86, p = 0.03) postoperatively. Four weeks after surgery, Patients in the PFMT arm showed significantly better scores compared toUCpatients in the following aspects: physical functioning (90.77 vs 74.63, p = 0.04), RP (75.00 vs 55.88, p = 0.05) and RE (86.46 vs 53.25, p = 0.05). INTERPRETATION OF RESULTS From our preliminary results an early formal PFMT could be able to improve some aspects of patients’ HR-QoL only 4 weeks after RARP, without impact on sexual function recovery. CONCLUSIONS We need a larger cohort with a suitable number of patients in order to corroborate or confute these preliminary findings