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Botulinum Toxin for Erectile Dysfunction

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ClinicalTrials.gov Identifier: NCT03102762
Recruitment Status : Unknown
Verified April 2017 by Hussein Ghanem, Cairo University.
Recruitment status was:  Recruiting
First Posted : April 6, 2017
Last Update Posted : April 6, 2017
Sponsor:
Information provided by (Responsible Party):
Hussein Ghanem, Cairo University

Study Description
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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.

Condition or disease Intervention/treatment Phase
Sexual Dysfunction Erectile Dysfunction Drug: Botulinum Toxin Type A Drug: Normal saline Phase 2 Phase 3

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.160 males with 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 (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 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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 160 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Prospective, randomized double blind placebo control ( RDBPC) study.
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Official Title: Intracavernosal Injection of Botulinum Toxin Type A in the Treatment of Erectile Dysfunction (Phase 2 Study)
Actual Study Start Date : January 3, 2017
Estimated Primary Completion Date : January 3, 2018
Estimated Study Completion Date : March 3, 2018

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: BTX-A Group
Experimental: BTX-A Group The treatment group, 80 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, 80 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.


Outcome Measures
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Primary Outcome Measures :
  1. Cavernosal Artery Mean PSV Before Treatment [ Time Frame: Baseline ]
    Baseline mean Peak systolic velocity (PSV) in the Cavernosal arteries, on color Doppler examination, in the patient and control groups.

  2. Cavernosal Artery Mean PSV After Treatment [ Time Frame: 2 weeks ]
    Cavernosal artery mean peak systolic velocity (PSV) after treatment, on color Doppler examination, in the patient and control groups.


Secondary Outcome Measures :
  1. SHIM score before treatment [ Time Frame: Baseline ]
    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.

  2. SHIM score after treatment [ Time Frame: 1 month ]
    Assessment of the Sexual Health Inventory for men (SHIM) questionnaire after 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.

  3. Penile size before treatment [ Time Frame: Baseline ]
    Measurement of penile length before treatment

  4. Penile size after treatment [ Time Frame: 1 month ]
    Measurement of penile length after treatment.

  5. Intra-vaginal latency time before treatment [ Time Frame: Baseline ]
    Measurement of the duration of intercourse from intromission to ejaculation before treatment.

  6. Intra-vaginal latency time after treatment [ Time Frame: 1 month ]
    Measurement of the duration of intercourse from intromission to ejaculation after treatment.


Eligibility Criteria
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Ages Eligible for Study:   40 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 160 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 40 to 70 years.

Exclusion Criteria:

- Significant cardiovascular disease interfering with sexual activity

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03102762


Contacts
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Contact: Hussein M Ghanem, MD 0020237613334 hmhghanem@gmail.com

Locations
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Egypt
Department of Andrology, Cairo University Recruiting
Cairo, Egypt, 11231
Contact: Hussein Ghanem, MD    0020237613334    hmhghanem@gmail.com   
Sponsors and Collaborators
Cairo University
Investigators
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Study Director: Islam M Fathy, MD Cairo University
More Information
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Additional Information:
Botulinum Toxin Type A and Erectile Dysfunction (Phase 1 study)  This link exits the ClinicalTrials.gov site

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.

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Responsible Party: Hussein Ghanem, Professor, Cairo University
ClinicalTrials.gov Identifier: NCT03102762     History of Changes
Other Study ID Numbers: 1232017
First Posted: April 6, 2017    Key Record Dates
Last Update Posted: April 6, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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

Keywords provided by Hussein Ghanem, Cairo University:
Erectile dysfunction
Botulinum toxin A
Botox

Additional relevant MeSH terms:
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Erectile Dysfunction
Sexual Dysfunction, Physiological
Genital Diseases, Male
Sexual Dysfunctions, Psychological
Mental Disorders
Botulinum Toxins
Botulinum Toxins, Type A
abobotulinumtoxinA
 Acetylcholine Release Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Neuromuscular Agents
Peripheral Nervous System Agents