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

NCT ID: NCT07188064

Last Updated: 2025-09-23

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-11-30
• Study Completion Date: 2028-12-31

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 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).

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 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.

Conditions

Prostate Cancer; Erectile Dysfunction Following Radical Prostatectomy

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Post radical prostatectomy nerve restoration procedure

A somatic to autonomic nerve grafting procedure which will use a nerve graft of ilioinguinal nerve harvested from the inguinal canal to perform a bilateral end to side junction between the dorsal penile nerve and the penile corpora cavernosa

Group Type: EXPERIMENTAL

Post radical prostatectomy nerve restoration procedure (PRP-NR)

Intervention Type: PROCEDURE

Somatic to autonomic nerve grafting procedure which uses a nerve graft of ilioinguinal nerve harvested from the inguinal canal to perform a bilateral end to side junction between the dorsal penile nerve and the penile corpora cavernosa

Interventions

Post radical prostatectomy nerve restoration procedure (PRP-NR)

Somatic to autonomic nerve grafting procedure which uses a nerve graft of ilioinguinal nerve harvested from the inguinal canal to perform a bilateral end to side junction between the dorsal penile nerve and the penile corpora cavernosa

Intervention Type: PROCEDURE

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

McGill University Health Centre/Research Institute of the McGill University Health Centre

OTHER

Sponsor Role: collaborator

Western University, Canada

OTHER

Sponsor Role: collaborator

Fox Chase Cancer Center

OTHER

Sponsor Role: collaborator

Sir Mortimer B. Davis - Jewish General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Victor McPherson

MD, MSc, FRCSC, Assistant Professor Division of Urology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

MP-05-2026-4654

Identifier Type: -

Identifier Source: org_study_id