Radiological Evaluation of the Penis Before and After a Botox Injection

September 19, 2023 updated by: Mohamed Wael Ragab, Cairo University

Role of Shear Wave Elastography in Assessment of Penile Cavernosal Elasticity and Response to Treatment by Botox Injection in Patients With Erectile Dysfunction.

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

32

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Cairo, Egypt
        • Recruiting
        • Faculty of Medicine, Cairo University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Men with ED not responding to oral PDE5Is.

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Men suffering from erectile dysfunction not responsive to phosphodiesterase-5 inhibitors (PDEI5Is)

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.
Procedure: Injection of Botulinum neurotoxin (BoNT)

Botulinum neurotoxin (BoNT) is produced by Clostridium botulinum, an anaerobic ,gram-positive bacterium. Poisoning with BoNT can cause botulism, resulting in generalized paralysis, respiratory failure, and death .There are seven serotypes of BoNT: A, B, C1, D, E, F, and G. BoNT-A is the most commonly used serotype for medical purposes.

Since its first use in 1977 for the treatment of strabismus in children, BoNT-A has since been used in aesthetic medicine and for the treatment of a number of disorders associated with overactive striated muscles, such as strabismus, esotropia, exotropia , focal dystonia, spasticity, and movement disorders.

BoNT-A has also been used in the management of some smooth-muscle disorders, such as achalasia, oesophageal spasm , ptyalism, hyperhidrosis, and intrinsic rhinitis, blepharospasm, muscle spasms and spasticity, axillary hyperhidrosis, and neurogenic detrusor muscle overactivity of the urinary bladder.

Diagnostic test: Penile duplex and shear wave elastosonography (SWE).
Penile duplex study using intracavernosal injection of prostaglandin E1 (PGE1) before and after Botox injection (in the follow-up visit in the 6th week after Botox injection). Penile cavernosal arteries diameters and colored waves will be assessed. Shear wave elastosonography will be conducted comparing the stiffness of penile tissues before and after Botox injection

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
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
Time Frame: 1 month
1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2023

Primary Completion (Estimated)

November 1, 2023

Study Completion (Estimated)

January 1, 2024

Study Registration Dates

First Submitted

September 12, 2023

First Submitted That Met QC Criteria

September 19, 2023

First Posted (Actual)

September 21, 2023

Study Record Updates

Last Update Posted (Actual)

September 21, 2023

Last Update Submitted That Met QC Criteria

September 19, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MS-191-2023

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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