Intracavernosal Injection of Botulinum Toxin Type A in the Treatment of Vascular Erectile Dysfunction

NCT02584686 | Completed Phase 1 Results DMC

• 1 other identifier: 1121015
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

Evidence has been arising that Botulinum toxin injections can relax smooth muscles fibers in the treatment of obesity and hyperactive bladder. Would a similar effect on cavernosal smooth muscles help in the treatment of resistant erectile dysfunction not responding to medical and injection therapy, thus avoiding surgical treatment options. The treatment group will be injected intracavernously with 50 units of BTX-A. The control group, 12 patients, will be injected with a normal saline injection.

Conditions

Vasculogenic Erectile Dysfunction

Outcome Measures

Primary Outcomes (2)

• Cavernosal Artery Mean PSV Before Treatment

  Baseline mean Peak systolic velocity (PSV) in the Cavernosal arteries, on color Doppler examination, in the patient and control groups, before treatment.

  Baseline

• Cavernosal Artery Mean PSV After Treatment

  Cavernosal artery mean peak systolic velocity (PSV) after treatment, on color Doppler examination, in the patient and control groups.

  2 weeks

Secondary Outcomes (9)

• EHS Before Treatment

  Baseline

• EHS After Treatment

  2 weeks

• SHIM Score Before Treatment

  Baseline

• SHIM Score After Treatment

  1 month

• Global Assessment Question (GAQ)

  1 month

Study Arms (2)

(BTX) A Group

EXPERIMENTAL

The treatment group will be injected intracavernously with a trimix solution for colour Doppler assessment, followed, on a separate day by 50 units of Botulinum toxin (BTX) A.

Drug: Botulinum Toxin Type A

Saline Group

PLACEBO COMPARATOR

The control group, 12 patients, will be injected with a trimix solution (20 ug alprostadil + 1 mg phentolamine + 30 mg papaverine) during penile colour Doppler assessment followed on a separate day with a normal saline injection.

Drug: Normal Saline

Interventions

Botulinum Toxin Type A DRUG

The treatment group will be injected intracavernously with a trimix solution (20 ug alprostadil + 1 mg phentolamine + 30 mg papaverine) for colour Doppler assessment, followed next day by 50 units of BTX-A.

(BTX) A Group

Normal Saline DRUG

The control group, 12 patients, will be injected with a trimix solution during penile colour Doppler assessment followed next day with a normal saline injection.

Saline Group

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• males will be included in the study recruited from Andrology, Sexology \& STD's outpatient clinic, Kasr El Aini Hospitals, Cairo University, complaining of Vascular ED proved by penile duplex.
• Unable to develop erections sufficient for intercourse.
• Failing to respond to first line and second line treatments for Erectile Dysfunction with surgery as the only remaining treatment option.
• Age between 40 to 70 years.

You may not qualify if:

• Significant cardiovascular disease interfering with sexual activity

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Cairo University Hospitals

Cairo, Cairo Governorate, 11321, Egypt

Location

MeSH Terms

Interventions

Botulinum Toxins, Type A; Saline Solution

Intervention Hierarchy (Ancestors)

Botulinum Toxins; Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases; Bacterial Proteins; Proteins; Amino Acids, Peptides, and Proteins; Bacterial Toxins; Toxins, Biological; Biological Factors; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Limitations and Caveats

Small sample size (24 total). Several questions need answering: Would a higher BTX-A give a better result? Would the results be maintained for the expected duration of BTX-A effectiveness period of 3 to 6 months?

Results Point of Contact

• Title: Prof. Dr. Hussein Ghanem, Chairman of Andrology Department
• Organization: Department of Andrlolgy, Sexology & STDs, Cairo University

hmhghanem@gmail.com

00201001176111

Study Officials

• Hussein Ghanem, MD, FECSM

  Cairo University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Chairman, Department of Andrology

Study Record Dates

• First Submitted: October 20, 2015
• First Posted: October 23, 2015
• Study Start: October 1, 2015
• Primary Completion: May 1, 2016
• Study Completion: May 1, 2016
• Last Updated: January 16, 2017
• Results First Posted: October 31, 2016

Record last verified: 2016-11

Locations

EG (1)