Vasculogenic Erectile Dysfunction Clinical Trial
Official title:
Intracavernosal Injection of Botulinum Toxin Type A in the Treatment of Vascular Erectile Dysfunction Not Responding to Oral and Intracavernous Therapy
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.
24 males with will be included in the study. All will be subjected for full history taking,
general and genital examination. Penile duplex will be performed to assess a vascular
etiology before the treatment and 2 weeks later. The patients will be randomized into a
treatment group (12 patients) and a control group (12 patients).
All patients will sign an informed consent. The treatment group will be injected IC with a
trimix solution (20 ug alprostadil + 1 mg phentolamine + 30 mg papaverine) for color Doppler
assessment, followed, next day by 50 units of BTX-A. The control group, 12 patients, will be
injected with the trimix solution during penile color Doppler assessment followed next day
with a normal saline injection. The erection hardness score (EHS) will be assessed during
the Doppler exam.
Procedure: At least 1 day after the penile color Doppler test, the patient is placed in the
supine position flaccid and stretched penile length and girth would be measured from tip of
the penis to the pubic bone will be done. A rubber band will be applied to the base of the
penis. The skin will be prepped with alcohol swabs followed by the IC injection of 50 units
of BTX-A. Direct pressure will be applied for 2 minutes. The rubber band will be removed
after 15 minutes.
Patients and controls will fill the Sexual Health Inventory for men (SHIM) questionnaire and
answer the the Sexual Encounter Profile questions 1 and 2 (SEP 2 & SEP 3), and the global
assessment question (GAQ) before and 4 weeks after treatment.
The rational for selecting the minimum 2-weeks waiting period is to give a chance for the
BTX-A to reach its maximum effect. Possible Risks include pain and prolonged erections.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
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