Journal Article

4-Aminopyridine treatment for nerve injury resulting from radical retro-pubic prostatectomy: a single-center double-blind, randomized, placebo-controlled study

Ghazi, Ahmed, Feng, Changyong, Horne, Andrea, Osinski, Thomas L., Elfar, John

2024

Overview

Background Prostate cancer (PCa) is the most common non-cutaneous malignancy in men and leads to the second most common cause of cancer related mortality in men. Early detection of PCa allows for a potentially curative intervention. Most men will live over a decade from the time of their PCa diagnosis. Thus, treatments must balance curative interventions with their impact on quality of life. Radical prostatectomy (RP) is one such potentially curative intervention but often leads to erectile dysfunction (ED) and urinary incontinence (UI). Approximately 90,000 RPs are performed each year in the USA. Post-operative ED and UI is thought to occur in part from traumatic peripheral nerve injury (TPNI) to the neurovascular bundles that surround the prostate. Thus, patients undergoing RP may be a population that would benefit from clinical studies that look at TPNI. Methods The study is a single-institution, double-blinded placebo-controlled, randomized clinical trial in which patients immediately post-RP receive either 4-aminopyrdine (4AP) or placebo in a 1:1 fashion. The primary outcome is evaluation of the efficacy of 4AP in accelerating the early return of baseline erectile and urinary function post-radical prostatectomy. Discussion This study is critical as it could reduce the morbidity associated with RP, a commonly performed operation, and identify a patient population that may greatly benefit into further TPNI research. Trial registration ClinicalTrials.gov NCT03701581. Prospectively registered on October 10, 2018.

• Publisher: BioMed Central,BioMed Central Ltd,Springer Nature B.V,BMC
• Subject: 4-Aminopyridine / 4AP / Antigens / Biomedicine / Biopsy / Cancer / Cancer therapies / Care and treatment / Clinical trials / Double-Blind Method / Drug dosages / Erectile dysfunction / Erectile Dysfunction - drug therapy / Erectile Dysfunction - etiology / FDA approval / Health aspects / Health Sciences / Humans / Impotence / Injuries / Male / Medicine / Medicine & Public Health / Metastasis / Middle Aged / Multiple sclerosis / Nerve injury / Oncology, Experimental / Orthopedics / Peripheral Nerve Injuries - drug therapy / Peripheral Nerve Injuries - etiology / Postoperative Complications - etiology / Prostate cancer / Prostatectomy / Prostatectomy - adverse effects / Prostatectomy - methods / Prostatic Neoplasms - surgery / Radiation / Randomized Controlled Trials as Topic / Recovery of Function / Statistics for Life Sciences / Study Protocol / Surgery / Trauma / Treatment Outcome / Urinary incontinence / Urinary Incontinence - etiology