Nerve Grafting Technique to Restore Erectile Function Post Radical Prostatectomy

NCT06458855 | Active Not Recruiting DMC

• 1 other identifier: 2024-4130
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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).

Conditions

Prostate Cancer; Erectile Dysfunction Following Radical Prostatectomy

Outcome Measures

Primary Outcomes (1)

• 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).

  Grade I - Deviation from normal p/o course. No pharmacological or surgical treatment, endoscopic or radiological interventions were required. Acceptable therapeutic drugs such as anti-emetics, antipyretics, analgesics, diuretics,electrolytes, physiotherapy. Wound infections, small abscess requiring incision at bedside. Grade II - Normal course altered. Pharmacological management other than in Grade I. Blood transfusions and total parenteral nutrition are also included. Grade III - Complications that require intervention of various degrees. Grade IIIa are complications that require an intervention performed under local anaesthesia. Grade IIIb are interventions that require general or epidural anaesthesia. Grade IV - Complications threatening life of patients (including Central Nervous System complications), requiring Intensive Treatment Unit support. Grade IVa are single organ dysfunction (including dialysis). Grade IVb is multi-organ dysfunction. Grade V - Death of a patient.

  Through study completion, an average of 2 years

Secondary Outcomes (12)

• International Index of Erectile Function-5 (IIEF-5)

  4 weeks post PRP-NR

• International Index of Erectile Function-5 (IIEF-5)

  3 months post PRP-NR

• International Index of Erectile Function-5 (IIEF-5)

  6 months post PRP-NR

• International Index of Erectile Function-5 (IIEF-5)

  12 months post PRP-NR

• International Index of Erectile Function-5 (IIEF-5)

  18 months post PRP-NR

Study Arms (1)

PRP-NR

EXPERIMENTAL

Post radical prostatectomy nerve restoration procedure

Procedure: Post radical prostatectomy nerve restoration procedure (PRP-NR)

Interventions

Post radical prostatectomy nerve restoration procedure (PRP-NR) PROCEDURE

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

PRP-NR

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Patients must have had good pre-prostatectomy erectile function with a baseline IIEF score of ≥17 on self-reported assessment of historic function.

You may not qualify if:

• Patients with previous pelvic radiotherapy
• Patients aged \< 18 years at diagnosis
• Legally incapable patients
• Patients who are unable to complete questionnaires and have no companion to help complete them
• Patients with pre-existing neurologic disease
• Patients with a history of bilateral surgeries for inguinal hernia repair.

Sponsors & Collaborators

• Sir Mortimer B. Davis - Jewish General Hospital: lead

Study Sites (1)

Jewish General Hospital

Montreal, Quebec, H3T 1E2, Canada

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Victor McPherson, MD

  Jewish General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, MSc, FRCSC, Assistant Professor Division of Urology

Study Record Dates

• First Submitted: May 21, 2024
• First Posted: June 14, 2024
• Study Start: July 17, 2024
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): September 1, 2027
• Last Updated: April 18, 2025

Record last verified: 2025-04

Locations

CA (1)