Intracavernosal Injection of Botulinum Toxin Type A in the Treatment of Vascular Erectile Dysfunction
Condition: Vasculogenic Erectile Dysfunction
MeSH terms: Erectile Dysfunction
Study type: Interventional
Phase: Phase 1

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.
    

Detailed description: 
      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.
    

Intervention name(s): Botulinum Toxin Type A; Normal Saline
Intervention type(s): Drug; Drug
Intervention description(s): The treatment group will be injected intracavernously with a trimix solution (20 ug alprostadil + 1 mg phentolamine + 30 mg papaverine) for colour Doppler assessment, followed next day by 50 units of BTX-A.; The control group, 12 patients, will be injected with a trimix solution during penile colour Doppler assessment followed next day with a normal saline injection.
Intervention MeSH terms: Botulinum Toxins; Botulinum Toxins, Type A; abobotulinumtoxinA
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment