Botulinum Toxin for Erectile Dysfunction

Intracavernosal Injection of Botulinum Toxin Type A in the Treatment of Erectile Dysfunction (Phase 2 Study)

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.

Study Overview

• Status: Completed
• Conditions: Sexual Dysfunction; Erectile Dysfunction
• Intervention / Treatment: Drug: Botulinum Toxin Type A; Drug: Normal saline

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.

• Study Type: Interventional
• Enrollment (Actual): 70
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt, 11231
    • Department of Andrology, Cairo University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 76 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Botulinum Toxin Type A (BTX-A) Group; Experimental: BTX-A Group The treatment group, 35 patients, will be injected with 100 units BTX-A one day following penile colour Doppler assessment.	Drug: Botulinum Toxin Type A; Drug: Botulinum Toxin Type A The treatment group will be injected with 100 units BTX-A one day following penile colour doppler assessment.
Placebo Comparator: Placebo Group; Saline Group: The control group, 35 patients, will be injected with 1 ml normal saline one day following penile colour Doppler assessment.	Drug: Normal saline; The treatment group will be injected with 1 ml normal saline one day following penile colour doppler assessment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Right (PSV R) and Left (PSV L) Cavernosal Artery Mean PSV Before Treatment	Baseline mean Peak systolic velocity (PSV) in the Cavernosal arteries, on color Doppler examination, in the patient and control groups.	Baseline
Right (PSV R) and Left (PSV L) Cavernosal Artery Mean PSV After Treatment	Cavernosal artery mean peak systolic velocity (PSV) after treatment, on color Doppler examination, in the patient and control groups.	2 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
SHIM Score Before Treatment	Assessment of the Sexual Health Inventory for men (SHIM) questionnaire before treatment for both groups. It is a questionnaire that helps asses if the patient has erectile dysfunction (ED) and assesses its degree. Results range from 1 to 25. A score of 1-7 denotes Severe ED, 8-11 Moderate ED, 12-16, Mild to Moderate ED, 17-21 Mild ED, 22-25 No ED.	Baseline
SHIM Score After Treatment	Assessment of the Sexual Health Inventory for men (SHIM) questionnaire after treatment for both groups. It is a questionnaire that helps to asses if the patient has erectile dysfunction (ED) and to assess its degree. Results range from 1 to 25. A score of 1-7 denotes Severe ED, 8-11 Moderate ED, 12-16, Mild to Moderate ED, 17-21 Mild ED, 22-25 No ED. Minimum value is 1, Maximum value is 25, the higher the score the better is the outcome.	2 weeks after injection.
SHIM Score After Treatment	Assessment of the Sexual Health Inventory for men (SHIM) questionnaire after 6 and 12 weeks of both groups. It is a questionnaire that helps to asses if the patient has erectile dysfunction (ED) and to assess its degree. Results range from 1 to 25. A score of 1-7 denotes Severe ED, 8-11 Moderate ED, 12-16, Mild to Moderate ED, 17-21 Mild ED, 22-25 No ED. Minimum value is 1, Maximum value is 25, the higher the score the better is the outcome.	6 and 12 weeks after injection.
Penile Size Before Treatment	Measurement of penile length before treatment: Flaccid, stretched and erect penile length.	Baseline
Penile Size After Treatment	Measurement of penile length after treatment.	2 weeks after injection.
Penile Size After Treatment	Measurement of penile length after treatment.	6 and 12 weeks after injection.
Intra-vaginal Latency Time Before Treatment	Measurement of the duration of intercourse from intromission to ejaculation before treatment.	Baseline
Intra-vaginal Latency Time After Treatment	Measurement of the duration of intercourse from intromission to ejaculation after treatment.	2 weeks after injection.
Intra-vaginal Latency Time After Treatment	Measurement of the duration of intercourse from intromission to ejaculation after treatment.	6 and 12 weeks after injection.

Collaborators and Investigators

• Sponsor: Cairo University
• Investigators: Study Director: Islam M Fathy, MD, Cairo University; Study Director: Abdelrahman A Hassan, Msc, Cairo University

Publications and helpful links

General Publications

• 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.

Helpful Links

• Botulinum Toxin Type A and Erectile Dysfunction (Phase 1 study)

Study record dates

Study Major Dates

• Study Start (Actual): January 3, 2017
• Primary Completion (Actual): January 10, 2019
• Study Completion (Actual): January 10, 2019

Study Registration Dates

• First Submitted: March 28, 2017
• First Submitted That Met QC Criteria: April 5, 2017
• First Posted (Actual): April 6, 2017

Study Record Updates

• Last Update Posted (Actual): January 7, 2020
• Last Update Submitted That Met QC Criteria: December 23, 2019
• Last Verified: December 1, 2019

More Information

Terms related to this study

• Keywords: Botulinum toxin A; Erectile dysfunction; Botox
• Additional Relevant MeSH Terms: Mental Disorders; Sexual Dysfunctions, Psychological; Sexual Dysfunction, Physiological; Erectile Dysfunction; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Cholinergic Agents; Membrane Transport Modulators; Acetylcholine Release Inhibitors; Neuromuscular Agents; Botulinum Toxins; Botulinum Toxins, Type A; abobotulinumtoxinA
• Other Study ID Numbers: 1232017

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes