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

Phase 2

• Conditions: Erectile Dysfunction
• Interventions: Biological: OnabotulinumtoxinA; Drug: Trimix

• Registration Number: NCT04172558
• Lead Sponsor: Benha University

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.

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 Timeline

• Study Start: 2019-03-10
• Study First Submitted: 2019-11-19
• Study First Submitted QC: 2019-11-20
• Study First Posted: 2019-11-21
• Status Verified: 2022-07
• Last Update Submitted: 2022-07-17
• Last Update Posted: 2022-07-19
• Primary Completion: 2022-10-01
• Study Completion: 2022-11-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 124

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
BTX100 group	OnabotulinumtoxinA	ICI of Botox 100 U
Trimix group	Trimix	ICI of Trimix

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

Banha University Hospitals; 🇪🇬 Banha, Kalubiaya, Egypt