PRELIMINARY DISAPPOINTED RESULTS FROM A PILOT RANDOMIZED TRIAL OF PREOPERATIVE PELVIC FLOOR MUSCLE TRAINING VERSUS USUAL CARE TO IMPROVE CONTINENCE AND HR-QOL AFTER RARP

INTRODUCTION AND AIM OF THE STUDY The aim of this study was to carry out a randomised controlled trial in order to determine a causal relationship between preoperative pelvic floor muscle training (PFMT) and postoperative functional outcomes in patients undergoing RARP. MATERIALS AND METHODS Itwas a double-arm, single- centre, pilot randomized control trial; men undergoing RARP were consecutively recruited and randomized to a pre- and post-operative PFMT program or usual care (UC). Intervention efficacy was evaluated at baseline (4–8 weeks preoperatively) and postoperatively at 4, 12, and 26 weeks. Urinary incontinence (UI) was assessed using the 24-hour pad test and the ICIQ-UI SF. Health related quality of life (HR-QoL) was measured using the SF 36; IPSS and IIEF-5 were used to assess urological symptoms and erectile function respectively. RESULTS From March 2017 to September 2017, 36 patients, satisfying inclusion and exclusion criteria, were consecutively enrolled and randomized; 22 entered PFMT arm and 14 the UC arm. Preoperatively all patients were continent; 4 weeks after RARP, 86.36% patients in PFMT arm and 85.72 in the UC had UI (p = NS). After 12 weeks 13.64% in the PFMT arm and 14.29% in the UC had UI (p = NS) having pad-test values, ICIQ-UI SF and IPSS scores comparable. Compared to baseline, 4 weeks after surgery, a worsening was observed in the following aspects: IIEF-5 (19.85 vs 3.73, p = 0.000), IPSS (5.29 vs 9.71, p = 0.004), SF 36 general health (GH) (93,42 vs 76.05, p = 0.000), role physical functioning (RP) (92.89 vs 72.21, p = 0.023) and role emotional functioning (RE) (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 GH(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 to UC patients 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 continence and sexual function recovery. CONCLUSIONS We need a larger cohort with a suitable number of patients in order to corroborate or confute these preliminary findings.