Background/Objectives: Stress urinary incontinence (SUI) remains a common and functionally relevant complication after radical prostatectomy (RP) and substantially impairs quality of life (QoL). Although pelvic floor muscle training (PFMT) is guideline-recommended, its real-world effectiveness is often limited by accessibility, standardization, and adherence. Digital health interventions may improve adherence to PFMT, potentially influencing continence recovery. We conducted a multicenter randomized controlled trial to evaluate whether a structured, modular app-based PFMT program improves early continence recovery compared with conventional physiotherapist-guided training. Methods: Between September 2022 and September 2024, 62 preoperatively continent men undergoing radical prostatectomy were enrolled in this multicenter randomized controlled trial (Pelvintense). Both groups received perioperative PFMT: Patients were randomized 1:1 to either a modular app-based PFMT program (intervention group) or a standard physiotherapist-guided PFMT (control group). Both app-based PFMT and standard physiotherapist-guided PFMT started three weeks before surgery and continued for 90 days postoperatively. The primary endpoint was continence at 90 days, defined as ICIQ-SF Q1 = 0 (absence of involuntary SUI). Secondary endpoints included continence sub-scores, QoL, erectile function, adherence, and decision regret. Analyses were performed using a modified intention-to-treat approach applying logistic regression and non-parametric tests with sensitivity analyses. Results: A total of 62 patients were included in the study and randomized, with 31 allocated to the app-based PFMT arm and 31 to the standard physiotherapist-guided arm. Three patients in the control arm withdrew consent for data usage after randomization, resulting in a modified intention-to-treat population of 59 patients. At 90 days, continence rates were higher in the app-based group compared with the control group (74.2% versus 21.4%; p < 0.001), corresponding to an absolute risk reduction of 52.8% and a number needed to treat of two. In multivariable analysis, participation in the app-based program was independently associated with higher odds of continence recovery (odds ratio 13.80, 95%-confidence interval 3.22–59.12; p < 0.001). Continence at 30 days and continence-related QoL favored the intervention, whereas no significant differences were observed in erectile function at 90 days. Adherence to the PFMT was higher in the intervention group. Sensitivity analyses confirmed the robustness of the primary outcome. Conclusions: In this randomized controlled trial, a modular app-based PFMT program was associated with early continence recovery after prostatectomy compared with the standard-of-care physiotherapist-guided PFMT. Improved adherence, modular progression of exercises, and a more structured training delivery may have contributed to the effect. App-based PFMT might represent a scalable strategy to implement guideline-recommended supportive care. These findings warrant confirmation in studies with a longer follow-up.
Barakat et al. (Wed,) studied this question.