Overview
A single arm prospective pilot trial evaluating the 1-year erectile recovery outcomes and the safety of patients undergoing a somatic to autonomic nerve grafting procedure for restoration of erectile function in patients who have lost erectile function following radical prostatectomy for prostate cancer. During this study a total of 100 patients who have persistent erectile dysfunction for more than 18 months post prostatectomy will undergo a post radical prostatectomy nerve restoration procedure (PRP-NR).
Description
The investigators are proposing a single arm prospective pilot study evaluating the safety and the 1-year erectile recovery outcomes of patients undergoing the PRP-NR procedure. A total of 100 patients will undergo the PRP-NR procedure, which is a novel nerve grafting procedure which will utilize a graft of the ilioinguial nerve to perform a bilateral end to side connection between the dorsal penile nerve and the corpora cavernosa with the intent to restore erectile function. Participants will have a baseline evaluation with IIEF-5 and SF-MPQ questionnaires, and then will have re-evaluation with these questionnaires at their standard of care post operative visits at 4 weeks, 3-, 6-, 12-, 18- and 24- months. Post operative safety will be assessed by recording any clinically detected complications during their peri- and post-operative care.
Eligibility
Inclusion Criteria:
- Patients with persistent post prostatectomy erectile dysfunction as defined below:
- Severe ED (IIEF score 5-7) and more than 12 months from prostatectomy OR
- Moderate ED (IIEF score 8-11) and more than 18 months from prostatectomy
- Patients must have had good pre-prostatectomy erectile function with a baseline IIEF score of ≥17 on self-reported assessment of historic function.
Exclusion Criteria:
- Patients aged \< 18 years at diagnosis
- Legally incapable patients
- Patients \>5 years from prostatectomy.
- Bilateral open inguinal hernia repair
- Patients with pre-existing significant neurologic disease
- Diabetes with evidence of peripheral nerve involvement and end organ dysfunction
- Coronary artery disease with unstable angina
- Mood disorder (anxiety/depression) with change in medical therapy within last 3 months
- Pre-existing penile base surgery which would prevent grafting technique including suprapubic liposuction, suspensory ligament release
- Pre-existing penile prosthesis
- Current use of androgen deprivation therapy
- Use of medications for chronic nerve pain (gabapentin, amitriptyline, nortriptyline, pregablin)
- Previous untreated penile trauma
- Patients deemed medically unfit for surgery
