Erectile Dysfunction Following Radical Prostatectomy, Prostate Cancer
Conditions
Brief summary
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).
Detailed description
The investigators are proposing a single arm prospective pilot study evaluating the safety and the 1-year erectile recovery outcomes of patients undergoing the PRP-NR procedure. A total of 100 patients will undergo the PRP-NR procedure, which is a novel nerve grafting procedure which will utilize a graft of the ilioinguial nerve to perform a bilateral end to side connection between the dorsal penile nerve and the corpora cavernosa with the intent to restore erectile function. Participants will have a baseline evaluation with IIEF-5 and SF-MPQ questionnaires, and then will have re-evaluation with these questionnaires at their standard of care post operative visits at 4 weeks, 3-, 6-, 12-, 18- and 24- months. Post operative safety will be assessed by recording any clinically detected complications during their peri- and post-operative care.
Interventions
Somatic 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
Sponsors
Sir Mortimer B. Davis - Jewish General Hospital
McGill University Health Centre/Research Institute of the McGill University Health Centre
Western University, Canada
Fox Chase Cancer Center
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
* Patients with persistent post prostatectomy erectile dysfunction as defined below: 1. Severe ED (IIEF score 5-7) and more than 12 months from prostatectomy OR 2. 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.
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| International Index of Erectile Function-5 (IIEF-5) | 4 weeks post PRP-NR | 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) | 24 months post PRP-NR | A one question visual questionnaire evaluating the erectile function, from 0 (no erection - Worst Possible Outcome) to 10 (sexual intercourse - Best Possible Outcome). |
| Short Form McGill Pain Questionnaire (SF-MPQ) | 24 months post PRP-NR | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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). | 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. |
Countries
Canada
Contacts
CONTACTVictor McPherson, MD
Outcome results
None listed