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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hussein Ghanem, Cairo University
ClinicalTrials.gov Identifier:
NCT02584686
First received: October 20, 2015
Last updated: November 18, 2016
Last verified: November 2016
  Purpose

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.


Condition Intervention Phase
Vasculogenic Erectile Dysfunction
Drug: Botulinum Toxin Type A
Drug: Normal Saline
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Intracavernosal Injection of Botulinum Toxin Type A in the Treatment of Vascular Erectile Dysfunction Not Responding to Oral and Intracavernous Therapy

Resource links provided by NLM:


Further study details as provided by Cairo University:

Primary Outcome Measures:
  • 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, before treatment.

  • 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:
  • EHS Before Treatment [ Time Frame: Baseline ]

    Clinical assessment of the Erection hardness score (EHS) in both groups after ICI at baseline.

    The Erection Hardness Score (EHS) is designed to measure the rigidity of erection. It ranges from 0 (no erection) to 4 (Fully rigid and hard erection).

    0 - Penis does not enlarge.

    1. - Penis is larger, but not hard.
    2. - Penis is hard, but not hard enough for penetration.
    3. - Penis is hard enough for penetration, but not completely hard.
    4. - Penis is completely hard and fully rigid. The average score is reported for each group.

  • EHS After Treatment [ Time Frame: 2 weeks ]

    Clinical assessment of the Erection hardness score (EHS) in both groups after ICI after 2 weeks.

    The Erection Hardness Score (EHS) is designed to measure the rigidity of erection. It ranges from 0 (no erection) to 4 (Fully rigid and hard erection).

    0 - Penis does not enlarge.

    1. - Penis is larger, but not hard.
    2. - Penis is hard, but not hard enough for penetration.
    3. - Penis is hard enough for penetration, but not completely hard.
    4. - Penis is completely hard and fully rigid. The average score is reported for each group.

  • 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.

  • SHIM Score After Treatment [ Time Frame: 1 month ]
    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.

  • Global Assessment Question (GAQ) [ Time Frame: 1 month ]
    Assessment of the effect of treatment by asking "Has the treatment you have been taking improved your erectile function?". The number answering "Yes" in both the treatment and control groups are calculated.

  • SEP-Q2 Question Before Treatment [ Time Frame: Baseline ]
    Number of patients answering "Yes" to the Sexual Encounter Profile question 2 (SEP-Q2: Were you able to insert your penis into your partner's vagina?)

  • SEP-Q2 Question After Treatment [ Time Frame: 1 month ]

    Number of patients answering "Yes" to the Sexual Encounter Profile question 2 (SEP-Q2: Were you able to insert your penis into your partner's vagina?) after treatment.

    This analysis compares the number of patients who were able to perform vaginal intromission (insert the penis into the partner's vagina) after treatment in the (BTX) A group versus the Saline group.


  • SEP-Q3 Question Before Treatment [ Time Frame: Baseline ]
    Number of patients answering "Yes" to the Sexual Encounter Profile question 3 (SEP-Q3: Did your erection last long enough for you to have successful intercourse?) before treatment.

  • SEP-Q3 Question After Treatment [ Time Frame: 1 month ]

    Number of patients answering "Yes" to the Sexual Encounter Profile question 3 (SEP-Q3: Did your erection last long enough for you to have successful intercourse?) after treatment.

    This analysis compares the number of patients who were able to maintain their erection long enough to complete sexual intercourse after treatment in the (BTX) A group versus the Saline group.



Enrollment: 24
Study Start Date: October 2015
Study Completion Date: May 2016
Primary Completion Date: May 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: (BTX) A Group
The treatment group will be injected intracavernously with a trimix solution for colour Doppler assessment, followed, on a separate day by 50 units of Botulinum toxin (BTX) A.
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.
Placebo Comparator: Saline Group
The control group, 12 patients, will be injected with a trimix solution (20 ug alprostadil + 1 mg phentolamine + 30 mg papaverine) during penile colour Doppler assessment followed on a separate day with a normal saline injection.
Drug: 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.

Detailed 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.

  Eligibility

Ages Eligible for Study:   40 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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.
  • 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02584686

Locations
Egypt
Cairo University Hospitals
Cairo, Egypt, 11321
Sponsors and Collaborators
Cairo University
Investigators
Principal Investigator: Hussein Ghanem, MD, FECSM Cairo University
  More Information

Responsible Party: Hussein Ghanem, Professor and Chairman, Department of Andrology, Cairo University
ClinicalTrials.gov Identifier: NCT02584686     History of Changes
Other Study ID Numbers: 1121015
Study First Received: October 20, 2015
Results First Received: June 10, 2016
Last Updated: November 18, 2016

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

ClinicalTrials.gov processed this record on March 24, 2017