4-aminopyridine Treatment for Nerve Injury From Radical Retro-Pubic Prostatectomy
Trial Snapshot
- Phase
- Phase 2
- Status
- Withdrawn
- Sponsor
- University of Rochester
- Locations
- 1
- Primary Endpoint
- percentage of participants with normal erectile dysfunction
Study Overview
Brief Summary
The purpose of this study is to see if the study drug 4-aminopyridine (4-AP) can help speed up the recovery of peripheral nerve injury after prostatectomy. 4-AP is a potassium channel blocker used to improve walking in multiple sclerosis patients. Investigators will measure the effect that 4-AP may have on the recovery of sexual function and urinary incontinence after prostatectomy.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 45 Years to 75 Years (Adult, Older Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
4-aminopyridine
Participants with recent prostatectomies receiving 4-aminopyridine
Intervention: 4-aminopyridine (Drug)
Placebo
Participants with recent prostatectomies receiving placebo
Intervention: placebo (Drug)
Outcomes
Primary Outcomes
percentage of participants with normal erectile dysfunction
Time Frame: 2 months
Erectile dysfunction will be assessed using the International Index of Erectile Function. Normal will be defined as a return to baseline. The index ranges from 0-75 with higher scores indicating better outcome. A score of 0-5 is awarded to each of the 15 questions that examine the 4 main domains of male sexual function: erectile function, orgasmic function, sexual desire and intercourse satisfaction.
Secondary Outcomes
- percentage of participants with normal erectile dysfunction(week 24)
- the time point at which the highest number of subjects reporting normal erectile dysfunction(baseline to month 12)
- percentage of participants with normal urinary continence(2 months)
Investigators
Ahmed Ghazi
Assistant Professor
University of Rochester