Recruiting

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

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About this study

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).

Condition: Prostate Cancer, Erectile Dysfunction Following Radical Prostatectomy
Tested: Post radical prostatectomy nerve restoration procedure (PRP-NR)
Sponsor: Sir Mortimer B. Davis - Jewish General Hospital

Who can join

Age: 18 years and older
Sex: Male only
Healthy volunteers: Not accepted

Inclusion 7

Minimum age: 18 years
Eligible sex: Male
Study condition: Prostate Cancer, Erectile Dysfunction Following Radical Prostatectomy
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 14

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

1 site, 1 recruiting

Jewish General Hospital

Montreal, Quebec, Canada

Recruiting

Contact

Victor McPherson, MD

514-340-8222 victor.mcpherson@mcgill.ca

Potential match only. Final eligibility is determined by the study team.