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Radiological Evaluation of the Penis Before and After a Botox Injection - Trial NCT06044883

Access comprehensive clinical trial information for NCT06044883 through Pure Global AI's free database. This Phase 1/2 trial is sponsored by Cairo University and is currently Recruiting. The study focuses on Erectile Dysfunction. Target enrollment is 32 participants.

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NCT06044883
Phase 1/2
Recruiting
procedure
Trial Details
ClinicalTrials.gov โ€ข NCT06044883
View on ClinicalTrials.gov
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Radiological Evaluation of the Penis Before and After a Botox Injection
Role of Shear Wave Elastography in Assessment of Penile Cavernosal Elasticity and Response to Treatment by Botox Injection in Patients With Erectile Dysfunction.

Study Focus

Erectile Dysfunction

Injection of Botulinum neurotoxin (BoNT)

Interventional

procedure

Sponsor & Location

Cairo University

Cairo, Egypt

Timeline & Enrollment

Phase 1/2

Jun 01, 2023

Jan 01, 2024

32 participants

Primary Outcome

The International Index of Erectile Function Questionnaire (IIEF-5) score in patients with erectile dysfunction correlated with penile elasticity.,Change from baseline in penile hardness using Shear wave elastosonography (SWE) after Intracavernosal injection by Botox at 6 weeks.,Change from baseline in the IIEF-5 score after Intracavernosal injection by Botox at 6 weeks.

Summary

The goal of this clinical trial is to find out if injecting Botox into men with erectile
 dysfunction makes their penis less stiff and gives them better erections. This will be done
 using a new ultrasound method. The main questions it tries to answer are: Is Botox injection
 safe and effective for men suffering from erectile dysfunction who failed other treatment
 methods? Does this new method have any radiological criteria for penile tissues? โ€ข If Botox
 is injected into the penis, is there a cut-off number for this technique that shows how much
 better things are before and after? Before and after treatment, participants will rate how
 much their erections have improved, and investigators will connect their answers to the
 findings

ICD-10 Classifications

Orgasmic dysfunction
Other disorders of penis
Other specified disorders of penis
Sexual dysfunction, not caused by organic disorder or disease
Testicular dysfunction

Data Source

ClinicalTrials.gov

NCT06044883

Non-Device Trial