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Intracavernosal Injection of Botulinum Toxin Type A (50 and 100 Unit) in the Treatment of Erectile Dysfunction

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ClinicalTrials.gov Identifier: NCT03355963
Recruitment Status : Completed
First Posted : November 29, 2017
Last Update Posted : November 26, 2019
Sponsor:
Collaborator:
Cairo University
Information provided by (Responsible Party):
Waleed El-Shaer, MD, Benha University

Brief Summary:

purpose: The aim of this study is to compare the safety, efficacy and durability of different doses of BTX-A (50 and 100 unit) in the treatment of Vasculogenic Erectile Dysfunction after failure of other ICI therapy.

Patients and Methods: This study will be conducted on 200 patients diagnosed as vascular erectile dysfunction by penile color Doppler not responding to medical and injection therapy presenting to Urology department and outpatient clinic at Benha University Hospital, Andrology, Sexology & STD's outpatient clinic, Kasr El Aini Hospitals, Cairo University.(multicentric study).

A- Inclusion criteria:

  • Age between 40 to 70 years.
  • 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.

B-Exclusion criteria:

  • Significant cardiovascular disease interfering with sexual activity
  • Any history of an unstable medical or psychiatric condition
  • Any presence of penile anatomical abnormalities (e.g. penile fibrosis) that would significantly impair erectile function.

patients will be simply randomized into 3 equal groups, one control group and two treatment groups. Ethics committee approval and informed consent were obtained.


Condition or disease Intervention/treatment Phase
Erectile Dysfunction Botulinum Toxin Other: saline injection Biological: Botulinum toxin type A 50 units Biological: Botulinum toxin type A 100 units Phase 2

Detailed Description:

introduction: Evidence has been arising suggesting that Botulinum toxin type A (BTX-A) injections can relax smooth muscles fibers in the treatment of obesity and Detrusor muscle over-activity, similar effect on cavernosal smooth muscles would help in the treatment of erectile dysfunction (ED) resistant to oral and intracavernous (IC) therapy, thus avoiding surgical treatment options.

patient and methods: All patients will perform penile color Doppler evaluation to confirm a vascular etiology, a trimix solution (PGE1 10 ug + Phentolamine 1 mg + Papaverine 30 mg) was injected IC during the penile Doppler study.

The control group: received an IC 1 ml saline injection one day after the penile Doppler/trimix test.

The treatment group B: received a single IC injection of BTX-A 50 units one day after the penile Doppler/trimix test.

The treatment group C: received a single IC injection of BTX-A 100 units one day after the penile Doppler/trimix test.

Assessment for all groups was done by penile color Doppler exam, Sexual Health Inventory for men (SHIM), Sexual Encounter Profile questions 2 and 3 (SEP 2 & SEP 3), and the global assessment question (GAQ) were completed pre-treatment and 2 weeks after treatment also, 3 and 6 months after treatment.

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 for patients in treatment group B and 100 units of BTX-A for patients in treatment group C with 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 ,Sexual Encounter Profile questions 2 and 3 (SEP 2 & SEP 3), and the global assessment question (GAQ) before and 2 weeks, 3 months and 6 months 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, also 3 months and 6 months after treatment do detect safety, efficacy and durability.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Comparative Study Between Intracavernosal Injection of Botulinum Toxin Type A (50 and 100 Unit) Efficacy and Durability in the Treatment of Vascular Erectile Dysfunction
Actual Study Start Date : July 12, 2016
Actual Primary Completion Date : January 25, 2019
Actual Study Completion Date : February 20, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: Group A
The control group: received an IC 1 ml saline injection one day after the penile Doppler/trimix test.
Other: saline injection
The control group: received an IC 1 ml saline injection one day after the penile Doppler/trimix test.
Other Name: group A (control group)

Active Comparator: Group B
The treatment group B: received a single IC injection of BTX-A 50 units one day after the penile Doppler/trimix test.
Biological: Botulinum toxin type A 50 units
The treatment group B: received a single IC injection of BTX-A 50 units one day after the penile Doppler/trimix test.
Other Name: group B

Active Comparator: Group C

The treatment group C:

intervention: received a single IC injection of BTX-A 100 units one day after the penile Doppler/trimix test.

Biological: Botulinum toxin type A 100 units
The treatment group C: received a single IC injection of BTX-A 100 units one day after the penile Doppler/trimix test.
Other Name: group C




Primary Outcome Measures :
  1. Erectile Function (EF) domain score of the International Index of Erectile Function (IIEF) [ Time Frame: pre-treatment and 2 weeks after treatment also, 3 and 6 months after treatment ]

    Changes in the Erectile Function (EF) domain score of the International Index of Erectile Function (IIEF) between treatment periods and baseline in different study arms. the score as follow:

    > 7 severe dysfunction 7-12 Moderate dysfunction

    13-18 Mild to moderate dysfunction

    19-24 Mild dysfunction

    25-30 No dysfunction


  2. the Sexual Event Profile (SEP) scores [ Time Frame: baseline, 2 weeks post treatment , 3, and 6 months post treatment ]
    Changes in the Sexual Event Profile (SEP) scores between treatment periods and baseline in different study arms by a <yes or no> response .

  3. Global Assessment Questionnaire (GAQ) scores [ Time Frame: baseline, 2 weeks post treatment , 3, and 6 months post treatment ]
    Changes in the Global Assessment Questionnaire (GAQ) scores between treatment periods in different study arms by a <yes or no> response

  4. Cavernosal artery peak systolic and end diastolic velocities [ Time Frame: baseline, 2 weeks post treatment , 3, and 6 months post treatment ]
    Change in Peak systolic velocity in the Cavernosal arteries, on color Doppler examination, in the patient and control groups.



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Layout table for eligibility information
Ages Eligible for Study:   40 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age between 40 to 70 years. 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.

Exclusion Criteria:

  • Significant cardiovascular disease interfering with sexual activity Any history of an unstable medical or psychiatric condition Any presence of penile anatomical abnormalities (e.g. penile fibrosis) that would significantly impair erectile function.
Layout table for additonal information
Responsible Party: Waleed El-Shaer, MD, Principal Investigator, Benha University
ClinicalTrials.gov Identifier: NCT03355963    
Other Study ID Numbers: 19-09-2016
First Posted: November 29, 2017    Key Record Dates
Last Update Posted: November 26, 2019
Last Verified: November 2019

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
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