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Trial Title:
Nerve Grafting Technique to Restore Erectile Function Post Radical Prostatectomy
NCT ID:
NCT06458855
Condition:
Prostate Cancer
Erectile Dysfunction Following Radical Prostatectomy
Conditions: Official terms:
Erectile Dysfunction
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Procedure
Intervention name:
Post radical prostatectomy nerve restoration procedure (PRP-NR)
Description:
A somatic to autonomic nerve grafting procedure which will use a nerve graft of
ilioinguinal nerve harvested from the inguinal canal to perform a bilateral end to side
junction between the dorsal penile nerve and the penile corpora cavernosa
Arm group label:
PRP-NR
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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Patients with persistent post prostatectomy erectile dysfunction more than 18 months
from prostatectomy and which results in the inability to achieve intercourse with
the aid of PDE5-I medications.
2. 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:
1. Patients with previous pelvic radiotherapy
2. Patients aged < 18 years at diagnosis
3. Legally incapable patients
4. Patients who are unable to complete questionnaires and have no companion to help
complete them
5. Patients with pre-existing neurologic disease
6. Patients with a history of bilateral surgeries for inguinal hernia repair.
Gender:
Male
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Jewish General Hospital
Address:
City:
Montréal
Zip:
H3T 1E2
Country:
Canada
Status:
Recruiting
Contact:
Last name:
Victor McPherson, MD
Phone:
514-340-8222
Phone ext:
24904
Email:
victor.mcpherson@gmail.com
Contact backup:
Last name:
Oleg Loutochin
Phone:
514-340-8222
Phone ext:
21627
Email:
oloutochin@jgh.mcgill.ca
Start date:
September 2024
Completion date:
September 2027
Lead sponsor:
Agency:
Sir Mortimer B. Davis - Jewish General Hospital
Agency class:
Other
Source:
Sir Mortimer B. Davis - Jewish General Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06458855
