Nerve Grafting for Erectile Dysfunction After Prostate Cancer Surgery (PRP-NR Trial)

N/A

Recruiting

Led By Victor McPherson, MD

Research Sponsored by Sir Mortimer B. Davis - Jewish General Hospital

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Must not have

Patients with a history of bilateral surgeries for inguinal hernia repair

Patients with previous pelvic radiotherapy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through study completion, an average of 2 years

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to assess the safety and effectiveness of a nerve grafting procedure in restoring erectile function in patients who have lost it after prostate cancer surgery. Ten patients with persistent erectile dysfunction will undergo this procedure

Who is the study for?

This trial is for men who've had prostate cancer surgery at least 18 months ago and are now experiencing persistent erectile dysfunction. It's a small study, aiming to include just 10 patients.

What is being tested?

The trial is testing a nerve grafting technique called PRP-NR that aims to restore erectile function in men who have lost it following prostate cancer surgery.

What are the potential side effects?

Since this is a surgical procedure, potential side effects may include pain, infection at the site of the graft, bleeding, or lack of improvement in erectile function.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had surgery on both sides for a groin hernia.

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I have had radiation therapy to my pelvic area before.

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I was diagnosed with my condition before turning 18.

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I am not legally able to make my own medical decisions.

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I cannot fill out questionnaires on my own and have no one to help me.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through study completion, an average of 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through study completion, an average of 2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, an average of 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

The 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).

Secondary study objectives

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

Short Form McGill Pain Questionnaire (SF-MPQ)