New nerve surgery to help men regain erections after prostate cancer surgery
Prospective Cohort Study of Somatic-Autonomic Nerve Grafting Technique to Restore Erectile Function in Patients With Persistent Erectile Dysfunction Post Radical Prostatectomy
This study will try a new nerve graft surgery using the ilioinguinal nerve to help men who lost erections after prostate removal regain erectile function within a year.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | Male |
| Sponsor | Sir Mortimer B. Davis - Jewish General Hospital Academic / other |
| Locations | 1 site (Montreal, Quebec) |
| Trial ID | NCT07188064 on ClinicalTrials.gov |
What this trial studies
This is a single-arm prospective pilot study enrolling 100 men with persistent erectile dysfunction after radical prostatectomy to receive a post-radical prostatectomy nerve restoration (PRP-NR) procedure. The surgery uses an ilioinguinal nerve graft to create bilateral end-to-side connections between the dorsal penile nerve and the corpora cavernosa with the goal of restoring erectile function. Participants will complete baseline IIEF-5 and SF-MPQ questionnaires and then be re-assessed at 4 weeks and at 3, 6, 12, 18, and 24 months to measure erectile recovery. Safety will be monitored by recording perioperative and postoperative clinical complications.
Who should consider this trial
Good fit: Men who had good erectile function before prostatectomy but now have persistent moderate-to-severe erectile dysfunction for at least 12–18 months after prostate removal, are within five years of surgery, and meet other health and neurologic criteria are the intended candidates.
Not a fit: Patients more than five years from prostatectomy, with significant neurologic disease, diabetic peripheral nerve involvement, prior inguinal surgeries that prevent grafting, unstable cardiac disease, or recent changes in mood disorder treatment are unlikely to benefit from this procedure.
Why it matters
Potential benefit: If successful, the procedure could restore erectile function and improve sexual quality of life for men who lost erections after prostate removal.
How similar studies have performed: This specific somatic-to-autonomic ilioinguinal nerve graft technique is novel with limited prior human data, though related nerve grafting approaches have been reported only in small case series.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients with persistent post prostatectomy erectile dysfunction as defined below: 1. Severe ED (IIEF score 5-7) and more than 12 months from prostatectomy OR 2. 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
Where this trial is running
Montreal, Quebec
- Jewish General Hospital — Montreal, Quebec, Canada (Recruiting)
Study contacts
- Study coordinator: Victor McPherson, MD
- Email: victor.mcpherson@mcgill.ca
- Phone: 514-340-8222
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.