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

NCT ID: NCT04172558

Last Updated: 2022-07-19

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 124 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-03-10
• Study Completion Date: 2022-11-01

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.

Conditions

Erectile Dysfunction

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

BTX100 group

ICI of Botox 100 U

Group Type: ACTIVE_COMPARATOR

OnabotulinumtoxinA

Intervention Type: BIOLOGICAL

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

Trimix group

ICI of Trimix

Group Type: ACTIVE_COMPARATOR

Trimix

Intervention Type: DRUG

on demand ICI of Trimix

Interventions

OnabotulinumtoxinA

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

Intervention Type: BIOLOGICAL

Trimix

on demand ICI of Trimix

Intervention Type: DRUG

Other Intervention Names

Grroup 1; Group 2

Eligibility Criteria

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.

• Minimum Eligible Age: 40 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Benha University

OTHER

Sponsor Role: lead

Responsible Party

Waleed El-Shaer, MD

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Waleed El-Shaer, MD

Role: PRINCIPAL_INVESTIGATOR

Banha Univesity hosptals

Locations

Banha University Hospitals

Banhā, Kalubiaya, Egypt

Site Status: RECRUITING

Countries

Egypt

Central Contacts

Waleed El-Shaer, MD

Role: CONTACT

waleed_elshaer@hotmail.com

01015767331

Facility Contacts

Waleed El-Shaer

Role: primary

Other Identifiers

IDIRB2017122601-34

Identifier Type: -

Identifier Source: org_study_id