Non-invasive biofeedback-assisted vs. conventional pelvic floor muscle training combined with high-effort resistance training for urinary incontinence after radical prostatectomy: a randomized controlled trial

Abstract Background Radical prostatectomy (RP) often leads to urinary incontinence (UI). There is sufficient evidence from randomized controlled trials (RCTs) that pelvic floor muscle and sphincter training (PFMT) are effective interventions to reduce UI. Objective To compare the effects of high-effort resistance training (HERT) combined with a non-invasive biofeedback-assisted device PFMT (dPFMT) versus HERT combined with conventional physiotherapeutic PFMT (pPFMT) on UI in prostate cancer patients undergoing RP. Methods Men with a history of RP for localized prostate cancer were randomly assigned to dPFMT ( n = 55) or pPFMT group ( n = 54). Both PFMT intervention groups underwent a 12-week whole body HERT program performed at moderate to high loads (> 60% 1-repetition maximum, performed to momentary failure). Measurements Urinary leakage was assessed with the 24-hour pad weight test (24-h pad test) at the baseline (T0) and at the end of the 12-week lasting programs (T1). Individual changes of cumulative pad weight in gram (g) from T0 to T1 were calculated and compared between groups. An UI reduction of ≥ 50% was considered as treatment success and compared between groups (primary endpoint). Results Ninety-six participants (88%) completed the intervention. All participants demonstrated a statistically significant reduction in 24-h pad test values from T0 to T1 (Mean (SD): -86.39 g (336.25 g); 𝑝 < 0.001). Treatment success did not differ between groups (OR = 1.19, 95% CI 0.53–2.66; 𝑝 = 0.670) and was achieved by 52.1% of all participants. In a post hoc exploratory analysis restricted to participants achieving treatment success, the relative reduction in urinary leakage from T0 to T1 was greater in the dPFMT group than in the pPFMT group (mean (SD) = -83.97% (13.88%) vs. -74.68% (12.93%); 𝑝 = 0.017). This exploratory finding should be interpreted with caution, particularly because no adjustment for multiple testing was applied. Time since surgery was a significant negative predictor of treatment success ( p < 0.001), whereas age ( p = 0.313) and follow-up rehabilitation treatment (AHB; p = 0.994) were not. None of the examined variables predicted the magnitude of change in urinary leakage. Conclusion Both device-based and physiotherapist-guided PFMT were associated with significant reductions in objectively measured urinary leakage after RP. No statistically significant between-group differences were observed under conditions evaluated in this study. Trial registration ClinicalTrials.gov Identifier NCT06206993, retrospectively registered on 15 December 2023.