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

Erectile Dysfunction Clinical Trial

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04172558
• Other study ID #: IDIRB2017122601-34
• Status: Recruiting
• Phase: Phase 2/Phase 3
• Start date: March 10, 2019
• Est. completion date: November 1, 2022

Study information

• Verified date: July 2022
• Source: Benha University
• Contact: Waleed El-Shaer, MD
• Phone: 01015767331
• Email: waleed_elshaer[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 124
• Est. completion date: November 1, 2022
• Est. primary completion date: October 1, 2022
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 40 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Erectile Dysfunction

Intervention

Biological:
• OnabotulinumtoxinA
a single ICI of BTX-A 100 units one day after the penile Doppler/trimix test.

Drug:
• Trimix
on demand ICI of Trimix

Locations

Country	Name	City	State
Egypt	Banha University Hospitals	Banha	Kalubiaya

Sponsors (1)

Lead Sponsor	Collaborator
Benha University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	International Index of Erectile Function (IIEF)	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
Primary	Dopller study	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
Primary	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	Erection hardness score which is ranged 0 to 4	baseline, 2 weeks post treatment then every 3 months post treatment
Secondary	Sexual Encounter Profile 2&3	Assessment of SEP before and after ICI. patient answer ' Yes' or 'No'.	baseline, 2 weeks post treatment then every 3 months post treatment
Secondary	Global Assessment Questionnaire	Global Assessment Questionnaire with Yes/No response	baseline, 2 weeks post treatment then every 3 months post treatment