drugset / Trial / NCT02584686

Intracavernosal Injection of Botulinum Toxin Type A in the Treatment of Vascular Erectile Dysfunction

NCT02584686

Phase 1 Completed 24 enrolled Cairo University
RandomizedParallel-groupDouble-blindTreatment

Summary

Evidence has been arising that Botulinum toxin injections can relax smooth muscles fibers in the treatment of obesity and hyperactive bladder. Would a similar effect on cavernosal smooth muscles help in the treatment of resistant erectile dysfunction not responding to medical and injection therapy, thus avoiding surgical treatment options. The treatment group will be injected intracavernously with 50 units of BTX-A. The control group, 12 patients, will be injected with a normal saline injection.

Timeline

Start
2015-10
Primary completion
2016-05
Completion
2016-05

Drugs

EvaluationDrugModalityDoseRoute
Subject Botulinum toxin type A Protein / enzyme biologic 50 iu Other
Background Alprostadil Unknown 20 ug Other
Background Papaverine Small molecule 30 mg Other
Background Phentolamine Small molecule 1 mg Other