Clinical trial NCT03102762: Botulinum Toxin for Erectile Dysfunction
Official title: Intracavernosal Injection of Botulinum Toxin Type A in the Treatment of Erectile Dysfunction (Phase 2 Study)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Sexual Dysfunction
Erectile Dysfunction
Keywords: Erectile dysfunction
Botulinum toxin A
Botox
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2017-04-06
Enrollment: 70
Sex: MALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective, randomized double blind placebo control ( RDBPC) study.
Primary purpose: TREATMENT

Brief summary: To evaluate the safety and efficacy of intra-cavernosal Botulinum toxin injection as an alternative line of treatment in patients with erectile dysfunction - not responding to oral PDE5i - through cavernosal smooth muscle relaxation.

Detailed description: The initial Phase 1 study demonstrated safety and efficacy of Botulinum toxin type A in the treatment of Erectile dysfunction in a small randomized controlled trial of 24 men.

The investigators conduct a phase 2 trial to confirm the initial results in a larger group of men.70 males will be included in the study. The participants 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 (35 patients) and a control group (35 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 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 100 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.

Eligibility criteria: Inclusion Criteria:

* 70 males will be included in the study recruited from Andrology, Sexology \& STD's outpatient clinic, Kasr El Aini Hospitals, Cairo University, complaining of ED.
* 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 18 to 80 years.

Exclusion Criteria:

- Significant cardiovascular disease interfering with sexual activity

Primary outcomes:
measure: Right (PSV R) and Left (PSV L) Cavernosal Artery Mean PSV Before Treatment
timeFrame: Baseline
measure: Right (PSV R) and Left (PSV L) Cavernosal Artery Mean PSV After Treatment
timeFrame: 2 weeks
Secondary outcomes:
measure: SHIM Score Before Treatment
timeFrame: Baseline
measure: SHIM Score After Treatment
timeFrame: 2 weeks after injection.
measure: SHIM Score After Treatment
timeFrame: 6 and 12 weeks after injection.
measure: Penile Size Before Treatment
timeFrame: Baseline
measure: Penile Size After Treatment
timeFrame: 2 weeks after injection.
measure: Penile Size After Treatment
timeFrame: 6 and 12 weeks after injection.
measure: Intra-vaginal Latency Time Before Treatment
timeFrame: Baseline
measure: Intra-vaginal Latency Time After Treatment
timeFrame: 2 weeks after injection.
measure: Intra-vaginal Latency Time After Treatment
timeFrame: 6 and 12 weeks after injection.
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Department of Andrology, Cairo University
Study officials:
affiliation: Cairo University
name: Islam M Fathy, MD
role: STUDY_DIRECTOR
affiliation: Cairo University
name: Abdelrahman A Hassan, Msc
role: STUDY_DIRECTOR
References:
citation: Ghanem H, Soliman I, AbdulHamid M, et. PS-08-016 Can intracavernosal botulinum toxin injection salvage vascular erectile dysfunction patients not responding to oral and intracavernous therapy? A pilot study. May 2016. Volume 13, Issue 5, Supplement 2, Page S116.