Radiological Evaluation of the Penis Before and After a Botox Injection

Phase 1

Recruiting

• Conditions: Erectile Dysfunction
• Interventions: Procedure: Injection of Botulinum neurotoxin (BoNT); Diagnostic Test: Penile duplex and shear wave elastosonography (SWE).

• Registration Number: NCT06044883
• Lead Sponsor: Cairo University

Brief 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? • 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

Detailed Description

Not available

Study Timeline

• Study Start: 2023-06-01
• Status Verified: 2023-09
• Study First Submitted: 2023-09-12
• Study First Submitted QC: 2023-09-19
• Last Update Submitted: 2023-09-19
• Study First Posted: 2023-09-21
• Last Update Posted: 2023-09-21
• Primary Completion: 2023-11-01
• Study Completion: 2024-01-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Male
• Target Recruitment: 32

Inclusion Criteria

• Men with ED not responding to oral PDE5Is.

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Exclusion Criteria

• Patients with penile prostheses.
• Patients diagnosed with Peyronie's disease.
• Non-vascular erectile dysfunction.
• Medical comorbidities that would limit the benefit of ICI such as uncontrolled diabetes mellitus, significant cardiovascular disease interfering with sexual activity, unstable psychiatric conditions, and the presence of anatomical, hormonal, or neurological abnormalities that would significantly impair erectile function.
• Patients with a history of radical pelvic surgery.
• Pelvic or spinal trauma

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Men suffering from erectile dysfunction not responsive to phosphodiesterase-5 inhibitors (PDEI5Is)	Penile duplex and shear wave elastosonography (SWE).	Our study involves male participants aged 18-70 years old suffering from erectile dysfunction and not responding to oral PDE5Is All patients are sexually active. They had no history of pelvic or spinal surgeries or trauma. Patients will be recruited from the Andrology department and outpatient clinics - Kasr Alainy- Cairo University hospitals. The study will be conducted in the ultrasound unit in the Radiology department- Kasr Alainy- Cairo University hospitals.
Men suffering from erectile dysfunction not responsive to phosphodiesterase-5 inhibitors (PDEI5Is)	Injection of Botulinum neurotoxin (BoNT)	Our study involves male participants aged 18-70 years old suffering from erectile dysfunction and not responding to oral PDE5Is All patients are sexually active. They had no history of pelvic or spinal surgeries or trauma. Patients will be recruited from the Andrology department and outpatient clinics - Kasr Alainy- Cairo University hospitals. The study will be conducted in the ultrasound unit in the Radiology department- Kasr Alainy- Cairo University hospitals.

Primary Outcome Measures

Name	Time	Method
Change from baseline in the IIEF-5 score after Intracavernosal injection by Botox at 6 weeks.	6 weeks	The International Index of Erectile Function Questionnaire (IIEF-5) is a questionnaire used by patients suffering from Erectile dysfunction to subjectively grade their condition. The score range from 5-25. and the erection status is classified into five categories based on the score: severe (5-7), moderate (8-11), mild to moderate (12-16), mild (17-21), no erectile dysfunction (22-25).
The International Index of Erectile Function Questionnaire (IIEF-5) score in patients with erectile dysfunction correlated with penile elasticity.	1 months	The International Index of Erectile Function Questionnaire (IIEF-5) is a questionnaire used by patients suffering from Erectile dysfunction to subjectively grade their condition. The score range from 5-25. and the erection status is classified into five categories based on the score: severe (5-7), moderate (8-11), mild to moderate (12-16), mild (17-21), no erectile dysfunction (22-25). The higher the score, the better the erection state.
Change from baseline in penile hardness using Shear wave elastosonography (SWE) after Intracavernosal injection by Botox at 6 weeks.	6 weeks	An elastosonographic method was introduced as a new ultrasound technique that provides information regarding the rigidity of tissues rather than their morphology. There are two types of elastosonographic methods: strain elastosonography and shear wave elastosonography (SWE). The unit used is kilopascals. The lower the values, the better the outcome. Rigid penis has stiffer tissues which have lower SWE values.

Secondary Outcome Measures

Name	Time	Method
A cut-off SWE value for determining significant pathological degree of elasticity of the cavernous tissue that would possibly benefit from ICI treatment by Botox	1 month

Trial Locations

Locations (1)

Faculty of Medicine, Cairo University; 🇪🇬 Cairo, Egypt