Status:
NOT_YET_RECRUITING
A Study Looking at a New Nerve Surgery to Help Men Regain Erections After Prostate Cancer Surgery
Lead Sponsor:
Sir Mortimer B. Davis - Jewish General Hospital
Collaborating Sponsors:
McGill University Health Centre/Research Institute of the McGill University Health Centre
Western University, Canada
Conditions:
Prostate Cancer
Erectile Dysfunction Following Radical Prostatectomy
Eligibility:
MALE
18+ years
Phase:
NA
Brief Summary
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 ...
Detailed 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 patient...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2028
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT07188064
Start Date
November 1 2025
End Date
December 1 2028
Last Update
September 23 2025
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