4-aminopyridine Treatment for Nerve Injury From Radical Retro-Pubic Prostatectomy

Phase 2

Withdrawn

• Conditions: Prostate Disease
• Interventions: Drug: placebo; Drug: 4-aminopyridine

• Registration Number: NCT03658408
• Lead Sponsor: University of Rochester

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-08-31
• Study First Submitted QC: 2018-08-31
• Study First Posted: 2018-09-05
• Status Verified: 2018-10
• Study Start: 2018-10-03
• Primary Completion: 2018-10-30
• Study Completion: 2018-10-30
• Last Update Submitted: 2018-10-31
• Last Update Posted: 2018-11-02

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: Male
• Target Recruitment: Not specified

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	placebo	Participants with recent prostatectomies receiving placebo
4-aminopyridine	4-aminopyridine	Participants with recent prostatectomies receiving 4-aminopyridine

Primary Outcome Measures

Name	Time	Method
percentage of participants with normal erectile dysfunction	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 Outcome Measures

Name	Time	Method
percentage of participants with normal erectile dysfunction	week 24	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.
the time point at which the highest number of subjects reporting normal erectile dysfunction	baseline to month 12	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.
percentage of participants with normal urinary continence	2 months	Incontinence will be assessed using the Michigan Incontinence Symptom Index. The Michigan Incontinence Symptom Index ranges from 0-40 with higher scores indicating more problems with urinary incontinence.

Trial Locations

Locations (1)

University of Rochester Medical Center; 🇺🇸 Rochester, New York, United States