A Study Looking at a New Nerve Surgery to Help Men Regain Erections After Prostate Cancer Surgery
Recruiting · NCT07188064 · Interventional (participants receive a specific treatment) · Lead sponsor: Sir Mortimer B. Davis - Jewish General Hospital
View the official record on ClinicalTrials.gov →Interventions studied
Post radical prostatectomy nerve restoration procedure (PRP-NR)
What this trial is 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).
Who can take part
Age range
18 Years and older
Sex
Male
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- 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 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 is running
1 location listed.
- Jewish General Hospital - Montreal, Quebec, Canada