A Study Looking at a New Nerve Surgery to Help Men Regain Erections After Prostate Cancer Surgery (PRP NG PRO M)

Sir Mortimer B. Davis - Jewish General Hospital

Status: Not yet enrolling

Conditions: Erectile Dysfunction Following Radical Prostatectomy; Prostate Cancer

Treatments: Procedure: Post radical prostatectomy nerve restoration procedure (PRP-NR)

Study type: Interventional

Funder types: Other

Identifiers

NCT07188064

MP-05-2026-4654

Details and patient eligibility

About

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).

Full 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.

Enrollment: 100 estimated patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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100 participants in 1 patient group

Post radical prostatectomy nerve restoration procedure

Experimental group

Description:

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

Treatment:

Procedure: Post radical prostatectomy nerve restoration procedure (PRP-NR)