New nerve surgery to help men regain erections after prostate cancer surgery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Jewish General Hospital
  Montreal, Quebec, Canada Recruiting

Study contacts

• Study coordinator: Victor McPherson, MD
• Email: victor.mcpherson@mcgill.ca
• Phone: 514-340-8222

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.