Intracavernous Injection of Botox 100 U for Treatment of PDE5Is Inconvenient Patients With ED

July 17, 2022 updated by: Waleed El-Shaer, MD, Benha University

Intracavernous Injection of Onabotulinumtoxin-A 100 U For Treatment of Phosphodiesterase Type 5 Inhibitors-Inconvenient Patients With Erectile Dysfunction: A Randamized Controlled Trial.

There is a new emerging concept that Botulinum Toxin Type A may have a potential role in treatment of erectile dysfunction with a longer duration of action. So, the investigators opted to perform this study to compare ICI of Botulinum Toxin Type A versus Trimix for treatment of ED.

Study Overview

Status

Status

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

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

Background: Direct Intracavernosal injections of vasoactive agents to treat erectile dysfunction were first described in 1982 using papaverine. Later on many agents have been introduced for ICI. one of most newly introduced ICI agents for treatment of ED is Botulinum Toxin Type A.

Purpose: The aim of this study will to compare the safety, efficacy, tolerability and adverse events s of ICI of BTX-A 100 unit in comparison with ICI Trimix in the treatment of Erectile Dysfunction for PDE5Is non-responders.

Design, Settings, and Participants: This study will be conducted on 124 patients at minimum, complain of erectile dysfunction not responding to different PDE5Is therapy presenting to Urology department and outpatient clinic at Banha University Hospital.

patients will be randomized into 2 equal groups: The treatment group A: will receive a single ICI of BTX-A 100 units . The treatment group B: will receive on-demand ICI of Trimix .

Assessment for all groups will be done by Sexual Health Inventory for men (SHIM), Sexual Encounter Profile questions 2 and 3 (SEP 2 & SEP 3), and the global assessment question (GAQ) based on pre-treatment, 2 weeks, 3 months and every 3 months after treatment.

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 (Anticipated)

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.
124

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
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Egypt
    • Kalubiaya
      • Banha, Kalubiaya, Egypt, 13518
        • Recruiting
        • Banha University Hospitals
        • Contact:
          • Waleed El-Shaer

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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Age more than 40 years with ED not responding to PDE5Is, non compliant or contraindicated to PDE5Is. A "No" response on Sexual encounter profile questions (SEP 2 & 3)

Exclusion Criteria:

  • 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: None (Open Label)

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.
Active Comparator: BTX100 group
ICI of Botox 100 U
Biological: OnabotulinumtoxinA
a single ICI of BTX-A 100 units one day after the penile Doppler/trimix test.
Other Names:
  • Grroup 1
Active Comparator: Trimix group
ICI of Trimix
Drug: Trimix
on demand ICI of Trimix
Other Names:
  • Group 2

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
International Index of Erectile Function (IIEF)
Time Frame: baseline, 2 weeks post treatment then every 3 months post treatment
Changes in the Erectile Function (EF) domain score of the International Index of change of Erectile Function measured by (IIEF) between treatment periods and baseline in the 2 study arms. It ranges between 0 to 25
baseline, 2 weeks post treatment then every 3 months post treatment
Dopller study
Time Frame: baseline, 2 weeks post treatment then every 3 months post treatment
measurement of Cavernosal artery peak systolic and end diastolic velocities before and after ICI
baseline, 2 weeks post treatment then every 3 months post treatment
Erection hardness score [ Time Frame: 2 weeks ] [ Designated as safety issue: No ] Clinical assessment of the Erection hardness score by the investigators in both Erection hardness score
Time Frame: baseline, 2 weeks post treatment then every 3 months post treatment
Erection hardness score which is ranged 0 to 4
baseline, 2 weeks post treatment then every 3 months post treatment

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Sexual Encounter Profile 2&3
Time Frame: baseline, 2 weeks post treatment then every 3 months post treatment
Assessment of SEP before and after ICI. patient answer ' Yes' or 'No'.
baseline, 2 weeks post treatment then every 3 months post treatment
Global Assessment Questionnaire
Time Frame: baseline, 2 weeks post treatment then every 3 months post treatment
Global Assessment Questionnaire with Yes/No response
baseline, 2 weeks post treatment then every 3 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

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Waleed El-Shaer, MD, Banha Univesity hosptals

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.
March 10, 2019

Primary Completion (Anticipated)

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.
October 1, 2022

Study Completion (Anticipated)

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.
November 1, 2022

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 19, 2019

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 20, 2019

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 21, 2019

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.
July 19, 2022

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.
July 17, 2022

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.
July 1, 2022

More Information

Terms related to this study

Keywords

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.
  • IDIRB2017122601-34

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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