Actively Recruiting
Prospective Cohort Study of Somatic-Autonomic Nerve Grafting to Restore Erectile Function in Men With Persistent Erectile Dysfunction After Radical Prostatectomy
Led by Sir Mortimer B. Davis - Jewish General Hospital · Updated on 2026-03-10
100
Participants Needed
1
Research Sites
4 weeks
Total Duration
On this page
Sponsors
S
Sir Mortimer B. Davis - Jewish General Hospital
Lead Sponsor
M
McGill University Health Centre/Research Institute of the McGill University Health Centre
Collaborating Sponsor
AI-Summary
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.
CONDITIONS
Brief Title
A Study Looking at a New Nerve Surgery to Help Men Regain Erections After Prostate Cancer Surgery
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male patients with persistent erectile dysfunction after prostatectomy
- Severe erectile dysfunction (IIEF score 5-7) and more than 12 months since prostatectomy OR moderate erectile dysfunction (IIEF score 8-11) and more than 18 months since prostatectomy
- Good erectile function before prostatectomy with a baseline IIEF score of 17 or higher based on self-report
You will not qualify if you...
- Patients younger than 18 years at diagnosis
- Legally incapable patients
- More than 5 years since prostatectomy
- History of bilateral open inguinal hernia repair
- Significant pre-existing neurologic disease
- Diabetes with peripheral nerve involvement and organ dysfunction
- Coronary artery disease with unstable angina
- Mood disorder with changes in medical therapy within last 3 months
- Previous penile base surgeries preventing grafting
- Existing penile prosthesis
- Current androgen deprivation therapy
- Use of medications for chronic nerve pain
- Previous untreated penile trauma
- Medically unfit for surgery
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Day of surgery and immediate recovery period
Participants undergo the PRP-NR nerve grafting procedure followed by immediate post-operative care to monitor safety and initial recovery.
1 surgery visit and peri-operative visits as part of routine care
Duration - Up to 24 months
Participants have follow-up visits to assess erectile function and pain using questionnaires at multiple time points after surgery and to monitor safety by recording any complications.
Visits at 4 weeks, 3, 6, 12, 18, and 24 months post-surgery
Trial Site Locations
Total: 1 location
1
Jewish General Hospital
Montreal, Quebec, Canada, H3T 1E2
Actively Recruiting
Research Team
V
Victor McPherson, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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