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

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02584686
• Other study ID #: 1121015
• Status: Completed
• Phase: Phase 1
• First received: October 20, 2015
• Last updated: May 24, 2016
• Start date: October 2015
• Est. completion date: May 2016

Study information

• Verified date: May 2016
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Egypt: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: May 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 40 Years to 70 Years

Eligibility

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.

• A "No" response on Sexual encounter profile questions (SEP 2 & 3)

• 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Erectile Dysfunction
• Vasculogenic Erectile Dysfunction

Intervention

Drug:
• Botulinum Toxin Type A
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.
• Normal Saline
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.

Locations

Country	Name	City	State
Egypt	Cairo University Hospitals	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cavernosal artery peak systolic velocity	Change in Peak systolic velocity in the Cavernosal arteries, on color Doppler examination, in the patient and control groups.	2 weeks	No
Primary	Cavernosal artery end diastolic velocity	Change in end diastolic velocity in the Cavernosal arteries, on color Doppler examination, in the patient and control groups.	2 weeks	No
Secondary	Erection hardness score	Clinical assessment of the Erection hardness score by the investigators in both groups.	2 weeks	No
Secondary	Clinical erectile function improvement	Comparison of the SHIM score (questionnaire) in the treatment and control groups.	1 month	No