|

Nerve Grafting Technique to Preserve Erectile Function in Patients Undergoing Robotic Assisted Radical Prostatectomy

RECRUITINGN/ASponsored by Sir Mortimer B. Davis - Jewish General Hospital
Actively Recruiting
PhaseN/A
SponsorSir Mortimer B. Davis - Jewish General Hospital
Started2024-09
Est. completion2027-09
Eligibility
Age18 Years+
SexMALE
Healthy vol.Accepted

Summary

The investigator proposing a single arm prospective pilot trial evaluating the safety and the 1-year erectile recovery outcomes of patients undergoing Nerve Restoring (NR) Robotically assisted laparoscopic radical prostatectomy (RALP). During this study a total of 10 patients who are undergoing robotic prostatectomy will have their surgery performed utilizing a novel technique, NR-RALP, which incorporates a genitofemoral (GFN) nerve graft designed to try to improve the erectile function and recovery of men undergoing standard of care robotic prostatectomy while minimizing additional morbidity of the procedure

Eligibility

Age: 18 Years+Sex: MALEHealthy volunteers accepted
Inclusion Criteria:

1. Patients undergoing standard of care robotic radical prostatectomy for high-risk localized prostate cancer as defined by any of:

   1. Gleason grade ≥8
   2. PSA ≥20
   3. \>pT2 on preoperative MRI imaging
2. Patients must have preoperative erectile function with a baseline IIEF score of ≥17

Exclusion Criteria:

1. Patients with previous pelvic surgery
2. Patients with previous pelvic radiotherapy
3. Patient with previous focal therapy for prostate cancer
4. Patients aged \< 18 years at diagnosis
5. Legally incapable patients
6. Patients who are unable to complete questionnaires and have no companion to help complete them
7. Patients undergoing a concomitant cancer surgery
8. Patients with pre-existing neurologic disease

Conditions3

CancerErectile DysfunctionProstate Cancer

Browse More Trials

Trial data from ClinicalTrials.gov. Trial status and eligibility can change — verify directly with the study contact or on ClinicalTrials.gov.

This site does not provide medical advice. Always consult your doctor before considering enrollment in a clinical trial. Learn more on our About page.