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Recruiting NCT07188064

A Study Looking at a New Nerve Surgery to Help Men Regain Erections After Prostate Cancer Surgery

No phase Interventional Prostate Cancer Erectile Dysfunction Following Radical Prostatectomy

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Post radical prostatectomy nerve restoration procedure (PRP-NR).
Who it may be relevant to
Registry conditions: Prostate Cancer, Erectile Dysfunction Following Radical Prostatectomy. Basic parameters: from 18 years · Male.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Canada
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Prospective Cohort Study of Somatic-Autonomic Nerve Grafting Technique to Restore Erectile Function in Patients With Persistent Erectile Dysfunction Post Radical Prostatectomy

Overview

A single arm prospective pilot trial evaluating the 1-year erectile recovery outcomes and the safety 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 100 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 100 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.

Interventions

  • Procedure Post radical prostatectomy nerve restoration procedure (PRP-NR)
    Somatic to autonomic nerve grafting procedure which uses 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

Primary outcome measures

  • International Index of Erectile Function-5 (IIEF-5) [Time frame: 4 weeks post PRP-NR]
  • International Index of Erectile Function-5 (IIEF-5) [Time frame: 3 months post PRP-NR]
  • Clinical Evolution of Erectile Function (CEEF) [Time frame: 24 months post PRP-NR]
  • Clinical Evolution of Erectile Function (CEEF) [Time frame: 18 months post PRP-NR]
  • Clinical Evolution of Erectile Function (CEEF) [Time frame: 12 months post PRP-NR]
  • Clinical Evolution of Erectile Function (CEEF) [Time frame: 6 months post PRP-NR]
  • Clinical Evolution of Erectile Function (CEEF) [Time frame: 3 months post PRP-NR]
  • Clinical Evolution of Erectile Function (CEEF) [Time frame: 4 weeks post PRP-NR]
  • Short Form McGill Pain Questionnaire (SF-MPQ) [Time frame: 24 months post PRP-NR]
  • Short Form McGill Pain Questionnaire (SF-MPQ) [Time frame: 18 months post PRP-NR]
Secondary outcome measures (1)
  • The secondary 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). [Time frame: Through study completion, an average of 2 years]

Eligibility criteria

Inclusion criteria

  • Patients with persistent post prostatectomy erectile dysfunction as defined below:
  • Severe ED (IIEF score 5-7) and more than 12 months from prostatectomy OR
  • Moderate ED (IIEF score 8-11) and more than 18 months from prostatectomy
  • 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

  • Patients aged < 18 years at diagnosis
  • Legally incapable patients
  • Patients >5 years from prostatectomy.
  • Bilateral open inguinal hernia repair
  • Patients with pre-existing significant neurologic disease
  • Diabetes with evidence of peripheral nerve involvement and end organ dysfunction
  • Coronary artery disease with unstable angina
  • Mood disorder (anxiety/depression) with change in medical therapy within last 3 months
  • Pre-existing penile base surgery which would prevent grafting technique including suprapubic liposuction, suspensory ligament release
  • Pre-existing penile prosthesis
  • Current use of androgen deprivation therapy
  • Use of medications for chronic nerve pain (gabapentin, amitriptyline, nortriptyline, pregablin)
  • Previous untreated penile trauma
  • Patients deemed medically unfit for surgery

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

Canada · 1 center
  • Jewish General Hospital — Montreal

Identifiers

NCT: NCT07188064 · MP-05-2026-4654

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗