NCT06521710

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

Phase I Clinical Trial: Pilot Study of Intraoperative Somatic-Autonomic Nerve Grafting Technique to Preserve Erectile Function in Patients With High Grade Prostate Cancer Undergoing Robotic Assisted Radical Prostatectomy

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 10 (estimated)
• Sponsor: Sir Mortimer B. Davis - Jewish General Hospital · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not 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

Detailed description

Patients will have baseline evaluation with International Index of Erectile Function-5 (IIEF-5) questionnaire and the Short Form McGill Pain Questionnaire (SF-MPQ)1, which will be re-evaluation at time of their standard of care post-operative visits at 4 weeks, 3-, 6-, 12- and 18-months. Post-operative safety will be assessed by recording any clinically detected complications during their peri- and post-operative care.

Conditions

• Prostate Cancer
• Erectile Dysfunction

Interventions

Type	Name	Description
PROCEDURE	Intraoperative Somatic-Autonomic Nerve Grafting	A one-sided graft using a genitofemoral (GFN) nerve graft between one obturator nerve and the corpora cavernosa

Timeline

• Start date: 2024-09-01
• Primary completion: 2027-09-01
• Completion: 2027-12-01
• First posted: 2024-07-26
• Last updated: 2024-09-19

Locations

2 sites across 1 country: Canada