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…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 77 participants or records.
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