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

November 24, 2019 updated by: Waleed El-Shaer, MD, Benha University

Comparative Study Between Intracavernosal Injection of Botulinum Toxin Type A (50 and 100 Unit) Efficacy and Durability in the Treatment of Vascular Erectile Dysfunction

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
200

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

40 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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 Names:
  • 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 Names:
  • 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 Names:
  • group C

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
pre-treatment and 2 weeks after treatment also, 3 and 6 months after treatment
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 .
baseline, 2 weeks post treatment , 3, and 6 months post treatment
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
baseline, 2 weeks post treatment , 3, and 6 months post treatment
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.
baseline, 2 weeks post treatment , 3, and 6 months post treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Benha University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Cairo University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 12, 2016

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 25, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 20, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 13, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 28, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 29, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 26, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 24, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 19-09-2016

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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