Viewing Study NCT06458855



Ignite Creation Date: 2024-06-16 @ 11:51 AM
Last Modification Date: 2024-10-26 @ 3:32 PM
Study NCT ID: NCT06458855
Status: RECRUITING
Last Update Posted: 2024-06-14
First Post: 2024-05-21

Brief Title: Nerve Grafting Technique to Restore Erectile Function Post Radical Prostatectomy
Sponsor: Sir Mortimer B Davis - Jewish General Hospital
Organization: Sir Mortimer B Davis - Jewish General Hospital

Study Overview

Official Title: Pilot Trial Pilot Study of Somatic-Autonomic Nerve Grafting Technique to Restore Erectile Function in Patients With Persistent Erectile Dysfunction Post Radical Prostatectomy
Status: RECRUITING
Status Verified Date: 2024-09
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: PRP-NR
Brief Summary: A single arm prospective pilot trial evaluating the safety and the 1-year erectile recovery outcomes 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 10 patients who have persistent erectile dysfunction for more than 18 months post prostatectomy will undergo a post radical prostatectomy nerve restoration procedure PRP-NR
Detailed Description: The investigators are proposing a single arm prospective pilot study evaluating the safety and the 1-year erectile recovery outcomes of patients undergoing the PRP-NR procedure A total of 10 patients will undergo the PRP-NR procedure which is a novel nerve grafting procedure which will utilize a graft of the ilioinguial nerve to perform a bilateral end to side connection between the dorsal penile nerve and the corpora cavernosa with the intent to restore erectile function Participants will have a baseline evaluation with IIEF-5 and SF-MPQ questionnaires and then will have re-evaluation with these questionnaires at their standard of care post operative visits at 4 weeks 3- 6- 12- 18- and 24- months Post operative safety will be assessed by recording any clinically detected complications during their peri- and post-operative care

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None