Nerve Grafting Technique to Restore Erectile Function Post Radical Prostatectomy (PRP-NR)

Sir Mortimer B. Davis - Jewish General Hospital

Status: Active, not recruiting

Conditions: Erectile Dysfunction Following Radical Prostatectomy; Prostate Cancer

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

Study type: Interventional

Funder types: Other

Identifiers

NCT06458855

2024-4130

Details and patient eligibility

About

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).

Full 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.

Enrollment: 10 estimated patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

PRP-NR

Experimental group

Description:

Post radical prostatectomy nerve restoration procedure

Treatment:

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