Prostate CancerErectile Dysfunction Following Radical Prostatectomy
Investigational drug(s) / intervention(s)
Post radical prostatectomy nerve restoration procedure (PRP-NR)
Post radical prostatectomy nerve restoration procedure (PRP-NR): 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
Study summary
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).
Eligibility
Sex
MALE
Min age
18 Years
Max age
—
Healthy volunteers
No
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.
Primary outcome measure(s)
The primary 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). — Through study completion, an average of 2 years Grade I - Deviation from normal p/o course. No pharmacological or surgical treatment, endoscopic or radiological interventions were required. Acceptable therapeutic drugs such as anti-emetics, antipyretics, analgesics, diuretics,electrolytes, physiotherapy. Wound infections, small abscess requiring incision at bedside.
Grade II - Normal course altered. Pharmacological management other than in Grade I. Blood transfusions and total parenteral nutrition are also included.
Grade III - Complications that require intervention of various degrees. Grade IIIa are complications that require an intervention performed under local anaesthesia. Grade IIIb are interventions that require general or epidural anaesthesia.
Grade IV - Complications threatening life of patients (including Central Nervous System complications), requiring Intensive Treatment Unit support. Grade IVa are single organ dysfunction (including dialysis). Grade IVb is multi-organ dysfunction.
Grade V - Death of a patient.
Trial sites (1)
Facility
City
Region
Status
Jewish General Hospital
Montreal
Quebec
More Sir Mortimer B. Davis - Jewish General Hospital trials in Canada
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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