Clinical trial NCT06458855: Nerve Grafting Technique to Restore Erectile Function Post Radical Prostatectomy
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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Prostate Cancer
Erectile Dysfunction Following Radical Prostatectomy
Lead sponsor: Sir Mortimer B. Davis - Jewish General Hospital
Sponsor class: OTHER
First posted: 2024-06-14
Enrollment: 10
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: The primary outcome is specifically the safety of the operation. This will be measured by adverse events as defined by the Clavian-Dindo classification.The measurement varies from Grade I (Best possible outcome) to Grade V (Worst possible outcome).
timeFrame: Through study completion, an average of 2 years
Secondary outcomes:
measure: International Index of Erectile Function-5 (IIEF-5)
timeFrame: 4 weeks post PRP-NR
measure: International Index of Erectile Function-5 (IIEF-5)
timeFrame: 3 months post PRP-NR
measure: International Index of Erectile Function-5 (IIEF-5)
timeFrame: 6 months post PRP-NR
measure: International Index of Erectile Function-5 (IIEF-5)
timeFrame: 12 months post PRP-NR
measure: International Index of Erectile Function-5 (IIEF-5)
timeFrame: 18 months post PRP-NR
measure: International Index of Erectile Function-5 (IIEF-5)
timeFrame: 24 months post PRP-NR
measure: Short Form McGill Pain Questionnaire (SF-MPQ)
timeFrame: 4 weeks post PRP-NR
measure: Short Form McGill Pain Questionnaire (SF-MPQ)
timeFrame: 3 months post PRP-NR
measure: Short Form McGill Pain Questionnaire (SF-MPQ)
timeFrame: 6 months post PRP-NR
measure: Short Form McGill Pain Questionnaire (SF-MPQ)
timeFrame: 12 months post PRP-NR
measure: Short Form McGill Pain Questionnaire (SF-MPQ)
timeFrame: 18 months post PRP-NR
measure: Short Form McGill Pain Questionnaire (SF-MPQ)
timeFrame: 24 months post PRP-NR
Other outcomes:
Locations:
city: Montréal
country: Canada
facility: Jewish General Hospital
state: Quebec
Study officials:
affiliation: Jewish General Hospital
name: Victor McPherson, MD
role: PRINCIPAL_INVESTIGATOR
References: