Radial wave therapy does not improve early recovery of erectile function after nerve-sparing radical prostatectomy: a prospective trial

Abstract

Background: Low intensity shockwave therapy is an emerging treatment option for men with vasculogenic erectile dysfunction. Radial wave therapy (rWT), which differs from focused shockwave (fSWT) as it produces lower pressure waves with lower peak energy, is used to treat soft tissue and skin conditions and has some data to support its use in vasculogenic erectile dysfunction. There is limited data for the use of rWT for the treatment of erectile dysfunction after nerve-sparing (NS) radical prostatectomy. We report the first trial of rWT for penile rehabilitation after NS radical prostatectomy.

Methods: We performed a prospective, non-randomized, open-label trial. Men with good pre-operative erectile function who underwent a NS radical prostatectomy at our institution from 2018-2020 were considered for inclusion. We compared post-operative erectile function outcomes between the rWT (6 weekly treatments initiated approximately 2 weeks post-operatively) plus standard of care (phosphodiesterase type 5 inhibitor) arm and the non-sham controlled standard of care arm. The primary end point for our study was the proportion of men who returned to "near normal" erectile function, defined as IIEF-5 score ≥17 and erectile hardness score (EHS) ≥3, by 3 months post-operatively between the intervention and control arm. We also compared mean IIEF-5 scores and median EHSs between the arms.

Results: One hundred and six patients were enrolled, of whom 73 patients had at least one reported survey response between 6 and 12 weeks post-operatively. Five (17%) and 11 (26%) patients recovered erectile function in the control and intervention arms, respectively, which was not a statistically significant difference (P=0.37). However, the intervention arm did have a significantly higher median EHS compared to the control arm (1 vs. 2, P=0.03). There were 4 adverse events related to pain during treatment and required only treatment intensity de-escalation.

Conclusions: rWT is safe but did not substantially improve the recovery of early erectile function after NS radical prostatectomy.

Keywords: Erectile dysfunction (ED); penile rehabilitation; prostate cancer; radial shockwave therapy; shockwave.

Figure 1

Time diagram of nerve sparing radical prostatectomy through outcome assessments. *, must meet all inclusion criteria: pre-operative IIEF-5 score ≥17 (with or without a phosphodiesterase type 5 inhibitor), underwent a bilateral nerve-sparing radical prostatectomy, as dictated on their operative report. Exclusion criteria included pre-operative moderate to severe erectile dysfunction (IIEF-5 score <17), non-nerve-sparing radical prostatectomy, adjuvant radiation therapy within the observation period (3 months post-operatively), Grade Group ≥4 prostate cancer or pre-operative vacuum erectile device or intracavernosal injection use. **, in addition to standard of care penile rehabilitation with a phosphodiesterase type 5 inhibitor. rWT, radial wave therapy; IIEF-5, international index of erectile function-5; EHS, erectile hardness score.