Erectile Dysfunction, Prostate Cancer
Conditions
Brief summary
The investigator proposing a single arm prospective pilot trial evaluating the safety and the 1-year erectile recovery outcomes of patients undergoing Nerve Restoring (NR) Robotically assisted laparoscopic radical prostatectomy (RALP). During this study a total of 10 patients who are undergoing robotic prostatectomy will have their surgery performed utilizing a novel technique, NR-RALP, which incorporates a genitofemoral (GFN) nerve graft designed to try to improve the erectile function and recovery of men undergoing standard of care robotic prostatectomy while minimizing additional morbidity of the procedure
Detailed description
Patients will have baseline evaluation with International Index of Erectile Function-5 (IIEF-5) questionnaire and the Short Form McGill Pain Questionnaire (SF-MPQ)1, which will be re-evaluation at time of their standard of care post-operative visits at 4 weeks, 3-, 6-, 12- and 18-months. Post-operative safety will be assessed by recording any clinically detected complications during their peri- and post-operative care.
Interventions
PROCEDUREIntraoperative Somatic-Autonomic Nerve Grafting
A one-sided graft using a genitofemoral (GFN) nerve graft between one obturator nerve and the corpora cavernosa
Sponsors
Sir Mortimer B. Davis - Jewish General Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Patients undergoing standard of care robotic radical prostatectomy for high-risk localized prostate cancer as defined by any of: 1. Gleason grade ≥8 2. PSA ≥20 3. \>pT2 on preoperative MRI imaging 2. Patients must have preoperative erectile function with a baseline IIEF score of ≥17
Exclusion criteria
1. Patients with previous pelvic surgery 2. Patients with previous pelvic radiotherapy 3. Patient with previous focal therapy for prostate cancer 4. Patients aged \< 18 years at diagnosis 5. Legally incapable patients 6. Patients who are unable to complete questionnaires and have no companion to help complete them 7. Patients undergoing a concomitant cancer surgery 8. Patients with pre-existing neurologic disease
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adverse events measured by the Clavian-Dindo classification | Through study completion, an average of 18 months | The primary outcome is specifically the safety of the operation 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 IV Complications threatening life of patients (including Central Nervous System complications), requiring Intensive Treatment Unit support. Grade V Death of a patient. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| International Index of Erectile Function-5 (IIEF-5) | Screening pre-NR-RALP procedure | 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). |
| Short Form McGill Pain Questionnaire (SF-MPQ) | Screening pre-NR-RALP procedure | The SF-MPQ was designed to measure post-surgical pain. The main component of the SF-MPQ consists of 15 descriptors (11 sensory; 4 affective) which are rated on an intensity scale as 0 = none, 1 = mild, 2 = moderate or 3 = severe. Three pain scores are derived from the sum of the intensity rank values of the words chosen for sensory, affective and total descriptors. The sum of the scores gives a range of outcomes; a score of 0 (no pain - Best Possible Outcome) to a score of 45 (Most severe pain - Worst Possible Outcome) |
Countries
Canada
Contacts
Primary ContactVictor McPherson, MD
Backup ContactOleg Loutochin
Outcome results
None listed