4-aminopyridine Treatment for Nerve Injury

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.

Eligibility

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 screening
* Has experienced at least 6 months of regular sexual activity and sexual activity during the 12 weeks prior to prostate biopsy or surgery
* Willingness to abstain from treatments for Erectile Dysfunction until 3 months after surgery
* Willingness to participate and able to provide informed consent

Exclusion Criteria

* Planned adjuvant therapy after NSRP based on specimen pathology and stage of prostate cancer (stage T3 or greater), positive lymph nodes or positive surgical margins
* Neo-adjuvant therapy prior to NSRP
* History of recurrent prostate cancer
* History of seizures, multiple sclerosis, stroke or any other diagnosed neurological disorder
* History of non-organ confined or metastatic prostate cancer (clinical Stages T3 or greater)
* History of known hypersensitivity to 4AP
* Patients with history of penile surgery other than circumcision or endoscopic urethral stricture surgery
* Renal impairment based on calculated GFR (GFR\<60 mL/min)
* Use of any other aminopyridine medications for any other indication

Conditions3

Locations2 sites

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