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).
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
Single group
Post radical prostatectomy nerve restoration procedure (PRP-NR)
Procedure/SurgerySomatic 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
International Index of Erectile Function-5 (IIEF-5)
The IIEF-5 is used to determine the prevalence of erectile dysfunction (ED) in a non-selected population using the abridged 5-item version of the International Index of Erectile Function (IIEF-5) as a diagnostic tool. Each answer has a score from 1 (very low) to 5 (very high). The sum of all the answers gives a final result of 1-7 (Severe ED - Worst Outcome), 8-11 (Moderate ED), 12-16 (Mild-moderate ED), 17-21 (Mild ED) and 22-25 (No ED - Best Outcome).
International Index of Erectile Function-5 (IIEF-5)
The IIEF-5 is used to determine the prevalence of erectile dysfunction (ED) in a non-selected population using the abridged 5-item version of the International Index of Erectile Function (IIEF-5) as a diagnostic tool. Each answer has a score from 1 (very low) to 5 (very high). The sum of all the answers gives a final result of 1-7 (Severe ED - Worst Outcome), 8-11 (Moderate ED), 12-16 (Mild-moderate ED), 17-21 (Mild ED) and 22-25 (No ED - Best Outcome).
Clinical Evolution of Erectile Function (CEEF)
A one question visual questionnaire evaluating the erectile function, from 0 (no erection - Worst Possible Outcome) to 10 (sexual intercourse - Best Possible Outcome).
Clinical Evolution of Erectile Function (CEEF)
A one question visual questionnaire evaluating the erectile function, from 0 (no erection - Worst Possible Outcome) to 10 (sexual intercourse - Best Possible Outcome).
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).
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.
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Sir Mortimer B. Davis - Jewish General Hospital
Lead sponsor
McGill University Health Centre/Research Institute of the McGill University Health Centre
Collaborator
Western University, Canada
Collaborator
Fox Chase Cancer Center
Collaborator
