Clinical trial NCT02584686: Intracavernosal Injection of Botulinum Toxin Type A in the Treatment of Vascular Erectile Dysfunction
Official title: Intracavernosal Injection of Botulinum Toxin Type A in the Treatment of Vascular Erectile Dysfunction Not Responding to Oral and Intracavernous Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Vasculogenic Erectile Dysfunction
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2015-10-23
Enrollment: 24
Sex: MALE
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility 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

Primary outcomes:
measure: Cavernosal Artery Mean PSV Before Treatment
timeFrame: Baseline
measure: Cavernosal Artery Mean PSV After Treatment
timeFrame: 2 weeks
Secondary outcomes:
measure: EHS Before Treatment
timeFrame: Baseline
measure: EHS After Treatment
timeFrame: 2 weeks
measure: SHIM Score Before Treatment
timeFrame: Baseline
measure: SHIM Score After Treatment
timeFrame: 1 month
measure: Global Assessment Question (GAQ)
timeFrame: 1 month
measure: SEP-Q2 Question Before Treatment
timeFrame: Baseline
measure: SEP-Q2 Question After Treatment
timeFrame: 1 month
measure: SEP-Q3 Question Before Treatment
timeFrame: Baseline
measure: SEP-Q3 Question After Treatment
timeFrame: 1 month
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Cairo University Hospitals
Study officials:
affiliation: Cairo University
name: Hussein Ghanem, MD, FECSM
role: PRINCIPAL_INVESTIGATOR
References: