Status:

COMPLETED

Intracavernosal Injection of Botulinum Toxin Type A (50 and 100 Unit) in the Treatment of Erectile Dysfunction

Lead Sponsor:

Benha University

Collaborating Sponsors:

Cairo University

Conditions:

Erectile Dysfunction

Botulinum Toxin

Eligibility:

MALE

40-70 years

Phase:

PHASE2

Brief Summary

purpose: The aim of this study is to compare the safety, efficacy and durability of different doses of BTX-A (50 and 100 unit) in the treatment of Vasculogenic Erectile Dysfunction after failure of ot...

Detailed Description

introduction: Evidence has been arising suggesting that Botulinum toxin type A (BTX-A) injections can relax smooth muscles fibers in the treatment of obesity and Detrusor muscle over-activity, similar...

Eligibility Criteria

Inclusion

  • Age between 40 to 70 years. Vascular ED proved by penile duplex. Unable to develop erections sufficient for intercourse. A "No" response on Sexual encounter profile questions (SEP 2 \& 3) Failing to respond to first line and second line treatments for Erectile Dysfunction with surgery as the only remaining treatment option.

Exclusion

  • Significant cardiovascular disease interfering with sexual activity Any history of an unstable medical or psychiatric condition Any presence of penile anatomical abnormalities (e.g. penile fibrosis) that would significantly impair erectile function.

Key Trial Info

Start Date :

July 12 2016

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

February 20 2019

Estimated Enrollment :

200 Patients enrolled

Trial Details

Trial ID

NCT03355963

Start Date

July 12 2016

End Date

February 20 2019

Last Update

November 26 2019

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