4-aminopyridine Treatment for Nerve Injury Resulting From Radical Retro-Pubic Prostatectomy
John Elfar
Summary
To evaluate the role of 4-aminopyridine (4-AP) on the course of recovery after peripheral nerve traction and/or crush injury. This study aims to test the hypothesis that 4-aminopyridine speeds the often slow and unpredictable recovery after peripheral nerve traction and/or crush injuries.
Description
To evaluate the role of 4-AP on the recovery of nerve function we will be giving patients with prostate cancer who are undergoing robot assisted radical prostatectomy (RP) either 4-AP or placebo in the perioperative period. This population of patients was selected as nerve crush injury during RP is thought to contribute to erectile dysfunction and urinary continence post operatively.
Eligibility
- Age range
- 45–75 years
- Sex
- Male
- Healthy volunteers
- No
Inclusion Criteria * Male patients with organ-confined, non-metastatic prostate cancer (stages cT1c-T2c), planning to undergo Robotic-Assisted Laparoscopic Bilateral Nerve Sparing Radical Prostatectomy (NSRP) * Prostate-Specific Antigen (PSA) levels less than 15 ng/ml (within the last 12 months), with biopsy-proven prostate cancer, for whom postoperative adjuvant therapy (e.g. radiation or androgen deprivation therapy) is not expected to be needed * Ages 45-75 * An Abridged International Index of Erectile Function-Erectile Function (IIEF-5) score of greater than or equal to 17 at time of scre…
Interventions
- Drug4-Aminopyridine
FDA-approved tablets.
- OtherPlacebo
Placebo will be tooled to look similar to the study drug.
Locations (2)
- University of ArizonaTucson, Arizona
- University of RochesterRochester, New York