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New treatment option for Prostate Cancer
Official title A Study Looking at a New Nerve Surgery to Help Men Regain Erections After Prostate Cancer Surgery
ClinicalTrials.gov ID: NCT07188064
What this study is testing
- What it's testing
- 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).
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, men only
You may be able to join if
- 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.
You likely can't join if
- 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
See the full eligibility 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.
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Montreal, Quebec, Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling male, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Montreal, Quebec, Canada. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.