Penile rehabilitation after radical prostatectomy using low-intensity shockwave therapy for erectile function: late results findings from a randomized clinical trial.

Abstract

Background: There is still few evidence to support the use of low-intensity extracorporeal shockwave therapy (LiESWT) in rehabilitation of erectile function after radical prostatectomy (RP).

Aim: The aim of this study is to assess the long-term results of LiWEST as a penile rehabilitation method in patients who underwent RP.

Methods: This is an assessment of the late results outcomes of our previous clinical trial registered in ReBEC (ensaiosclinicos.gov.br) RBR-85HGCG. Patients were randomized in two groups with two parallel arms and an allocation ratio of 1:1. The control group received tadalafil 5 mg/day, while the experimental group received tadalafil 5 mg/day and were submitted to 2400 shocks/session-week distributed on four different penile regions across 8 weeks of treatment. Both groups started the penile rehabilitation after the removal of the transurethral catheter. Sexual function was assessed by International Index of Erectile Function (IIEF-5) score.

Outcomes: A difference in IIEF-5 without statistical significance between the experimental and control groups.

Results: Among 77 patients included in our previous analysis, 35 patients were reassessed after a median follow-up of 45 months (95% CI, 42-50 months). Seventeen of them had to be excluded from the analysis for biochemical recurrence and/or new interventions. Remaining 7 and 11 patients in the experimental and control group, respectively. The final mean IIEF-5 score between experimental and control groups showed a difference in favor of the LiWEST group, not statistically significant (18.85, SD 5.66, 95% CI, 13.61-24.1 x 16.63, SD 5.48, 95%CI, 12.9- 20.31; respectively; P = 0.42). Subgroup analysis in patients still using IPDE5 there is a higher difference between mean IIEF5, however not statistically significantly (18.5, SD 6.12, 95%CI 12.07-24.92 x 15.85, SD 3.62, 95% CI, 12.50-19.20, P = 0.35).

Clinical implications: This study highlights that LiESWT may offer limited long-term benefit for erectile function recovery after RP.

Strengths & limitations: This study provides valuable long-term data on the use of LiESWT as a penile rehabilitation method after RP. The randomized design and parallel group structure strengthen the reliability Journal of Sexual Medicine Journal of Sexual Medicine For Peer Review of findings, with clear intervention protocols. However, limitations include a small final sample size due to patient exclusions, which likely impacted statistical power and the generalizability of results. Additionally, while differences in IIEF-5 scores favored the LiESWT group, the lack of statistical significance limits the ability to draw definitive conclusions about its effectiveness.

Conclusion: The LiESWT showed no impact on long-term results of penile rehabilitation in patients submitted to RP.