Nerve Surgery for Erectile Dysfunction After Prostate Cancer
(PRP NG PRO M Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores a new surgical procedure to help men regain erectile function after prostate cancer surgery. The focus is on a nerve grafting technique, known as the Post Radical Prostatectomy Nerve Restoration procedure (PRP-NR), which aims to restore nerve connections crucial for erections. Men who have experienced persistent erectile dysfunction for over 18 months following prostate surgery and had good erectile function before the surgery might be eligible. This procedure could offer a promising option for those facing severe or moderate erectile issues after prostate cancer treatment. As an unphased trial, this study provides a unique opportunity for patients to contribute to pioneering research that could lead to new treatment options.
Will I have to stop taking my current medications?
The trial requires that you stop using medications for chronic nerve pain, such as gabapentin, amitriptyline, nortriptyline, and pregabalin. If you are on these medications, you would need to discontinue them to participate.
What prior data suggests that this nerve grafting procedure is safe for erectile dysfunction recovery?
Research has shown that a nerve grafting procedure used to treat erectile dysfunction after prostate surgery is promising in terms of safety. Studies found that 71% of men regained erectile function after undergoing this procedure. This suggests the procedure can be effective and generally well-tolerated. Available studies have reported no significant serious side effects linked to this procedure. While this is encouraging, individual experiences may vary, so discussing potential risks with a healthcare provider is always advisable.12345
Why are researchers excited about this trial?
Unlike the standard treatments for erectile dysfunction after prostate cancer, which often involve medications like PDE5 inhibitors (e.g., Viagra or Cialis) or devices such as vacuum erection devices and penile implants, the post radical prostatectomy nerve restoration procedure (PRP-NR) offers a surgical approach aimed at restoring nerve function directly. This procedure is unique because it involves a somatic to autonomic nerve grafting technique, using a nerve graft from the ilioinguinal nerve to form new connections between the dorsal penile nerve and the penile corpora cavernosa. Researchers are excited about this method as it targets the root cause of erectile dysfunction by attempting to repair and restore the natural nerve pathways, potentially leading to a more permanent solution compared to temporary symptom management.
What evidence suggests that the post radical prostatectomy nerve restoration procedure might be an effective treatment for erectile dysfunction?
Studies have shown that nerve grafting, specifically the post radical prostatectomy nerve restoration procedure (PRP-NR), helped 71% of men regain erectile function after prostate surgery. This method connects nerves to restore function. Research indicates that many men experience erectile dysfunction (ED) after prostate surgery, with rates as high as 68%. Given these challenges, nerve grafting appears promising for aiding recovery. Early results suggest that this procedure could significantly improve erectile function for those facing difficulties after surgery.12678
Are You a Good Fit for This Trial?
This trial is for men who had good erections before prostate cancer surgery but now have moderate to severe erectile dysfunction lasting over a year after their prostate was removed. They must not have any other major health issues that would prevent them from having surgery.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants undergo the post radical prostatectomy nerve restoration procedure (PRP-NR) to restore erectile function
Post-operative Monitoring
Participants are monitored for safety and effectiveness with evaluations at 4 weeks, 3, 6, 12, 18, and 24 months post-surgery
Follow-up
Participants are monitored for long-term safety and erectile function recovery
What Are the Treatments Tested in This Trial?
Interventions
- Post radical prostatectomy nerve restoration procedure (PRP-NR)
Trial Overview
The study tests a new nerve grafting surgery (PRP-NR) designed to restore erections in men with long-term erectile dysfunction after prostate removal for cancer. All participants receive the procedure and are followed for one year.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
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
Find a Clinic Near You
Who Is Running the Clinical Trial?
Sir Mortimer B. Davis - Jewish General Hospital
Lead Sponsor
Western University, Canada
Collaborator
McGill University Health Centre/Research Institute of the McGill University Health Centre
Collaborator
Fox Chase Cancer Center
Collaborator
Citations
Nerve Repair for Erectile Dysfunction After Radical ... - PMC
Current guidelines recommend radical prostatectomy (RP) as the treatment of choice, which may result in 59%–79% in ED at 2–5 years after ...
NCT07188064 | A Study Looking at a New Nerve Surgery ...
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 ...
Ten-year Outcomes of Sexual Function After Radical ...
After an expected initial decline following RP, most men experience significant improvements in SF and EF through 2 yr after RP. Beyond 2 yr, SF and EF are ...
4.
ctv.veeva.com
ctv.veeva.com/study/a-study-looking-at-a-new-nerve-surgery-to-help-men-regain-erections-after-prostate-cancer-surgeryA Study Looking at a New Nerve Surgery to Help Men Regain ...
During this study a total of 100 patients who have persistent erectile dysfunction for more than 18 months post prostatectomy will undergo a ...
5.
hopkinsmedicine.org
hopkinsmedicine.org/health/conditions-and-diseases/prostate-cancer/erectile-dysfunction-after-prostate-cancerErectile Dysfunction After Prostate Cancer
About 75% of men who undergo nerve-sparing prostatectomy or more precise forms of radiation therapy have reported successfully achieving erections after using ...
6.
ctv.veeva.com
ctv.veeva.com/study/nerve-grafting-technique-to-restore-erectile-function-post-radical-prostatectomyNerve Grafting Technique to Restore Erectile Function Post ...
A single arm prospective pilot trial evaluating the safety and the 1-year erectile recovery outcomes of patients undergoing a somatic to ...
Nerve Grafting for Erectile Dysfunction After Prostate ...
Specifically, studies found that this nerve grafting helped 71% of men regain erectile function after prostate surgery. This suggests the procedure can be ...
Are We Improving Erectile Function Recovery After Radical ...
The probability that a patient will have adequate erectile function (EF) after radical prostatectomy (RP) has been reported to be 35% at 2 yr in a large, long- ...
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