Pilot Study of a New Nerve Grafting Surgery to Restore Erectile Function in Men with Persistent Erectile Dysfunction After Prostate Cancer Surgery

What this Trial Is About

Researchers are evaluating a new nerve grafting surgery called the post radical prostatectomy nerve restoration PRP-NR procedure to help men regain erectile function after prostate cancer surgery. This single arm pilot study aims to assess the safety and 1-year erectile recovery outcomes in patients who have persistent erectile dysfunction for more than 18 months following radical prostatectomy. The procedure uses the ilioinguinal nerve to connect the dorsal penile nerve to the corpora cavernosa with the goal of restoring function. The study involves 100 male patients undergoing the PRP-NR surgery, which is a novel somatic to autonomic nerve grafting technique. Participants will have nerve grafts taken from the inguinal canal and receive a bilateral end-to-side nerve connection during the operation. Evaluations will be conducted at baseline and during standard post-operative visits at 4 weeks, 3, 6, 12, 18, and 24 months. The study will also monitor safety by documenting any complications occurring during and after surgery. Participants will complete erectile function questionnaires IIEF-5 and pain assessments SF-MPQ at multiple time points up to 2 years after surgery. Researchers will track erectile function recovery and surgical safety using standard clinical classifications. The total follow-up period extends to 24 months, with repeated assessments to observe changes in erectile function and any adverse events related to the nerve restoration procedure.

A Study Looking at a New Nerve Surgery to Help Men Regain Erections After Prostate Cancer Surgery