PI: Giuseppe Simone
Other IRE Principal Collaborators Involved: Aldo Brassetti, Mariaconsiglia Ferriero, Elisa Melucci, Rosa Lauretta, Riccardo Mastroianni, Gabriele Tuderti

Project duration: 24 months

Project code: PNRR-MCNT2-2023-12377570

This is a multicenter prospective randomized controlled trial (RCT) investigating the efficacy of Low-intensity Extracorporeal Shock Wave Therapy (Li-ESWT) combined with PDE5 inhibitors (PDE5i) for the treatment of erectile dysfunction (ED) following nerve-sparing Robot-Assisted Radical Prostatectomy (RARP). The study compares the combined therapy (Li-ESWT + PDE5i) against PDE5i alone. The hypothesis is that the combined approach will lead to faster and better recovery of erectile function, measured by the International Index of Erectile Function-5 (IIEF-5) score, compared to PDE5i monotherapy. The study will enroll men under 75 years old who have undergone nerve-sparing RARP with a preoperative IIEF-5 score above 16 and specific low-risk prostate cancer criteria. Patients with prior pelvic irradiation, pelvic surgery, or those unable to tolerate PDE5i will be excluded. Participants will be randomized into two groups: Li-ESWT + PDE5i or PDE5i alone. The Li-ESWT protocol involves 12,000 shocks over six weeks, starting shortly after surgery. Data on sexual function (IIEF-5, EHS), continence, quality of life, and adverse events will be collected at 3, 6, and 12 months post-surgery, including a washout period at 1 year to assess function without medication. A parallel pilot study will evaluate Li-ESWT plus PDE5i for ED and continence recovery after nerve-sparing radical cystectomy for bladder cancer.

Primary Aim: To determine if Li-ESWT combined with early PDE5i administration is superior to PDE5i alone in improving penile rehabilitation of ED after nerve-sparing RARP, measured by the IIEF-5 score at 3, 6, and 12 months post-surgery.

Secondary Aims:

• To compare adverse effects (classified by Clavien-Dindo) between the two treatment groups.
• To compare health-related quality of life (HRQoL) outcomes at 3, 6, and 12 months.
• To compare the rate of patients achieving orgasm and their erectile hardness score (EHS) at 12 months.
• Exploratory Analysis: To evaluate the potential impact of Li-ESWT on continence recovery after RARP.

Pilot Study Aim: To investigate the role of Li-ESWT for ED rehabilitation and continence recovery in patients undergoing nerve-sparing radical cystectomy for bladder cancer.

The study anticipates demonstrating that combining Li-ESWT with PDE5i will become the new standard of care for postoperative ED rehabilitation after nerve-sparing RARP. It is expected that the combined therapy will result in a statistically significant improvement in IIEF-5 scores, indicating better erectile function recovery, compared to PDE5i alone. The pilot study is expected to provide preliminary data on the potential benefits of Li-ESWT in patients undergoing radical cystectomy. The results will contribute high-level evidence to guide future therapeutic strategies for post-operative ED.