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

• Status: Completed
• Trial end date: 2016-05-01
• Target enrollment: 0
• Participant gender: Male

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Cairo University
• Treatments: abobotulinumtoxinA; Botulinum Toxins; Botulinum Toxins, Type A; incobotulinumtoxinA; onabotulinumtoxinA; Pharmaceutical Solutions

Criteria

Inclusion Criteria:

• 24 males will be included in the study recruited from Andrology, Sexology & STD's outpatient clinic, Kasr El Aini Hospitals, Cairo University, complaining of Vascular ED proved by penile duplex.

• Unable to develop erections sufficient for intercourse.

• Failing to respond to first line and second line treatments for Erectile Dysfunction with surgery as the only remaining treatment option.

• Age between 40 to 70 years.

Exclusion Criteria:

• Significant cardiovascular disease interfering with sexual activity