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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
70
FDA-approved tablets.
Placebo will be tooled to look similar to the study drug.
University of Arizona
Tucson, Arizona, United States
RECRUITINGUniversity of Rochester
Rochester, New York, United States
TERMINATEDMichigan Incontinence Sympton Index (M-ISI) (change over time)
Incontinence measurement (change over time)
Time frame: Pre-operative visit, and every seven days (starting after surgery, i.e., 7 days post-op) for 6 months (up to 25 times).
International Index of Erectile Function (IIEF) (change over time)
Erectile function measurement tool. (change over time)
Time frame: Pre-operative visit, and every seven days (starting after surgery, i.e., 7 days post-op) for 6 months (up to 25 times).
Placebo vs. Active Drug Questionnaire
Specific questions regarding patient blinding
Time frame: through study completion, an average of 1 year
Drug Diary
Subjects will record the time each day that they take the study drug/ placebo.
Time frame: Daily for 90 days.
Attempted Sexual Activity Questionnaire
Sexual activity assessment
Time frame: Pre-operative visit, and every seven days (starting after surgery, i.e., 7 days post-op) for 6 months (up to 25 times).
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