Botulinum Toxin for Erectile Dysfunction

NCT ID: NCT03102762

Last Updated: 2020-01-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-01-03
• Study Completion Date: 2019-01-10

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.

Conditions

Sexual Dysfunction; Erectile Dysfunction

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

Botulinum Toxin Type A

Intervention Type: DRUG

Drug: Botulinum Toxin Type A The treatment group will be injected with 100 units BTX-A one day following penile colour doppler assessment.

Placebo Group

Saline Group:

The control group, 35 patients, will be injected with 1 ml normal saline one day following penile colour Doppler assessment.

Group Type: PLACEBO_COMPARATOR

Normal saline

Intervention Type: DRUG

The treatment group will be injected with 1 ml normal saline one day following penile colour doppler assessment.

Interventions

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.

Intervention Type: DRUG

Normal saline

The treatment group will be injected with 1 ml normal saline one day following penile colour doppler assessment.

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Hussein Ghanem

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Islam M Fathy, MD

Role: STUDY_DIRECTOR

Cairo University

Abdelrahman A Hassan, Msc

Role: STUDY_DIRECTOR

Cairo University

Locations

Department of Andrology, Cairo University

Cairo, , Egypt

Countries

Egypt

References

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.

Reference Type: BACKGROUND

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Related Links

https://clinicaltrials.gov/ct2/show/record/NCT02584686

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

Other Identifiers

1232017

Identifier Type: -

Identifier Source: org_study_id