Radiological Evaluation of the Penis Before and After a Botox Injection

NCT06044883 | Unknown Phase 1 DMC

• 1 other identifier: MS-191-2023
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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

Conditions

Erectile Dysfunction

Outcome Measures

Primary Outcomes (3)

• The International Index of Erectile Function Questionnaire (IIEF-5) score in patients with erectile dysfunction correlated with penile elasticity.

  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.

  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.

  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 Outcomes (1)

• 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

Study Arms (1)

Men suffering from erectile dysfunction not responsive to phosphodiesterase-5 inhibitors (PDEI5Is)

EXPERIMENTAL

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); Diagnostic Test: Penile duplex and shear wave elastosonography (SWE).

Interventions

Injection of Botulinum neurotoxin (BoNT) PROCEDURE

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.

Men suffering from erectile dysfunction not responsive to phosphodiesterase-5 inhibitors (PDEI5Is)

Penile duplex and shear wave elastosonography (SWE). DIAGNOSTIC_TEST

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

Men suffering from erectile dysfunction not responsive to phosphodiesterase-5 inhibitors (PDEI5Is)

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men with ED not responding to oral PDE5Is.

You may not qualify if:

• 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

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Faculty of Medicine, Cairo University

Cairo, Egypt

RECRUITING

MeSH Terms

Conditions

Erectile Dysfunction

Condition Hierarchy (Ancestors)

Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Sexual Dysfunction, Physiological; Male Urogenital Diseases; Sexual Dysfunctions, Psychological; Mental Disorders

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer

Study Record Dates

• First Submitted: September 12, 2023
• First Posted: September 21, 2023
• Study Start: June 1, 2023
• Primary Completion: November 1, 2023
• Study Completion: January 1, 2024
• Last Updated: September 21, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)