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

Recruiting

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Anticipated)

124

Phase

  • 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 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

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
Intervention / Treatment
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

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

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

Benha University

Investigators

  • 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)

March 10, 2019

Primary Completion (Anticipated)

October 1, 2022

Study Completion (Anticipated)

November 1, 2022

Study Registration Dates

First Submitted

November 19, 2019

First Submitted That Met QC Criteria

November 20, 2019

First Posted (Actual)

November 21, 2019

Study Record Updates

Last Update Posted (Actual)

July 19, 2022

Last Update Submitted That Met QC Criteria

July 17, 2022

Last Verified

July 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID 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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