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

Sponsor

Benha University (Other)

Overall Status

Recruiting

CT.gov ID

NCT04172558

Collaborator

(none)

124

Enrollment

Location

Arms

43.8

Anticipated Duration (Months)

2.8

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Erectile Dysfunction	Biological: OnabotulinumtoxinA Drug: Trimix	Phase 2/Phase 3

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 Design

Study Type:

Interventional

Anticipated Enrollment :

124 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Mar 10, 2019

Anticipated Primary Completion Date :

Oct 1, 2022

Anticipated Study Completion Date :

Nov 1, 2022

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

International Index of Erectile Function (IIEF) [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
Dopller study [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
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 [baseline, 2 weeks post treatment then every 3 months post treatment]
Erection hardness score which is ranged 0 to 4

Secondary Outcome Measures

Sexual Encounter Profile 2&3 [baseline, 2 weeks post treatment then every 3 months post treatment]
Assessment of SEP before and after ICI. patient answer ' Yes' or 'No'.
Global Assessment Questionnaire [baseline, 2 weeks post treatment then every 3 months post treatment]
Global Assessment Questionnaire with Yes/No response

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years and Older

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Banha University Hospitals	Banha	Kalubiaya	Egypt	13518

Sponsors and Collaborators

Benha University

Investigators

Principal Investigator: Waleed El-Shaer, MD, Banha Univesity hosptals

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Waleed El-Shaer, MD, Principal Investigator, Benha University

ClinicalTrials.gov Identifier:

NCT04172558

Other Study ID Numbers:

IDIRB2017122601-34

First Posted:

Nov 21, 2019

Last Update Posted:

Jul 19, 2022

Last Verified:

Jul 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Keywords provided by Waleed El-Shaer, MD, Principal Investigator, Benha University

Botulimium Toxin

Eractile Dysfunction

ICI

Additional relevant MeSH terms:

Erectile Dysfunction

Botulinum Toxins, Type A

abobotulinumtoxinA

Study Results

No Results Posted as of Jul 19, 2022