A Study Looking at a New Nerve Surgery to Help Men Regain Erections After Prostate Cancer Surgery
NCT07188064
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).
Eligibility
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
Conditions3
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NCT07188064