Intracavernosal Injection of Botulinum Toxin Type A (50 and 100 Unit) in the Treatment of Erectile Dysfunction

November 24, 2019 updated by: Waleed El-Shaer, MD, Benha University

Comparative Study Between Intracavernosal Injection of Botulinum Toxin Type A (50 and 100 Unit) Efficacy and Durability in the Treatment of Vascular Erectile Dysfunction

purpose: The aim of this study is to compare the safety, efficacy and durability of different doses of BTX-A (50 and 100 unit) in the treatment of Vasculogenic Erectile Dysfunction after failure of other ICI therapy.

Patients and Methods: This study will be conducted on 200 patients diagnosed as vascular erectile dysfunction by penile color Doppler not responding to medical and injection therapy presenting to Urology department and outpatient clinic at Benha University Hospital, Andrology, Sexology & STD's outpatient clinic, Kasr El Aini Hospitals, Cairo University.(multicentric study).

A- Inclusion criteria:

  • Age between 40 to 70 years.
  • Vascular ED proved by penile duplex.
  • Unable to develop erections sufficient for intercourse.
  • A "No" response on Sexual encounter profile questions (SEP 2 & 3)
  • Failing to respond to first line and second line treatments for Erectile Dysfunction with surgery as the only remaining treatment option.

B-Exclusion criteria:

  • Significant cardiovascular disease interfering with sexual activity
  • Any history of an unstable medical or psychiatric condition
  • Any presence of penile anatomical abnormalities (e.g. penile fibrosis) that would significantly impair erectile function.

patients will be simply randomized into 3 equal groups, one control group and two treatment groups. Ethics committee approval and informed consent were obtained.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

introduction: Evidence has been arising suggesting that Botulinum toxin type A (BTX-A) injections can relax smooth muscles fibers in the treatment of obesity and Detrusor muscle over-activity, similar effect on cavernosal smooth muscles would help in the treatment of erectile dysfunction (ED) resistant to oral and intracavernous (IC) therapy, thus avoiding surgical treatment options.

patient and methods: All patients will perform penile color Doppler evaluation to confirm a vascular etiology, a trimix solution (PGE1 10 ug + Phentolamine 1 mg + Papaverine 30 mg) was injected IC during the penile Doppler study.

The control group: received an IC 1 ml saline injection one day after the penile Doppler/trimix test.

The treatment group B: received a single IC injection of BTX-A 50 units one day after the penile Doppler/trimix test.

The treatment group C: received a single IC injection of BTX-A 100 units one day after the penile Doppler/trimix test.

Assessment for all groups was done by penile color Doppler exam, Sexual Health Inventory for men (SHIM), Sexual Encounter Profile questions 2 and 3 (SEP 2 & SEP 3), and the global assessment question (GAQ) were completed pre-treatment and 2 weeks after treatment also, 3 and 6 months after treatment.

Procedure:

At least 1 day after the penile color Doppler test, the patient is placed in the supine position flaccid and stretched penile length and girth would be measured from tip of the penis to the pubic bone will be done. A rubber band will be applied to the base of the penis. The skin will be prepped with alcohol swabs followed by the IC injection of 50 units of BTX-A for patients in treatment group B and 100 units of BTX-A for patients in treatment group C with direct pressure will be applied for 2 minutes. The rubber band will be removed after 15 minutes.

Patients and controls will fill the Sexual Health Inventory for men (SHIM) questionnaire and answer the ,Sexual Encounter Profile questions 2 and 3 (SEP 2 & SEP 3), and the global assessment question (GAQ) before and 2 weeks, 3 months and 6 months after treatment .

The rational for selecting the minimum 2-weeks waiting period is to give a chance for the BTX-A to reach its maximum effect. Possible Risks include pain and prolonged erections, also 3 months and 6 months after treatment do detect safety, efficacy and durability.

Study Type

Interventional

Enrollment (Actual)

200

Phase

  • Phase 2

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

40 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Age between 40 to 70 years. Vascular ED proved by penile duplex. Unable to develop erections sufficient for intercourse. A "No" response on Sexual encounter profile questions (SEP 2 & 3) Failing to respond to first line and second line treatments for Erectile Dysfunction with surgery as the only remaining treatment option.

Exclusion Criteria:

  • Significant cardiovascular disease interfering with sexual activity Any history of an unstable medical or psychiatric condition Any presence of penile anatomical abnormalities (e.g. penile fibrosis) that would significantly impair erectile function.

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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Group A
The control group: received an IC 1 ml saline injection one day after the penile Doppler/trimix test.
Other: saline injection
The control group: received an IC 1 ml saline injection one day after the penile Doppler/trimix test.
Other Names:
  • group A (control group)
Active Comparator: Group B
The treatment group B: received a single IC injection of BTX-A 50 units one day after the penile Doppler/trimix test.
Biological: Botulinum toxin type A 50 units
The treatment group B: received a single IC injection of BTX-A 50 units one day after the penile Doppler/trimix test.
Other Names:
  • group B
Active Comparator: Group C

The treatment group C:

intervention: received a single IC injection of BTX-A 100 units one day after the penile Doppler/trimix test.
Biological: Botulinum toxin type A 100 units
The treatment group C: received a single IC injection of BTX-A 100 units one day after the penile Doppler/trimix test.
Other Names:
  • group C

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Erectile Function (EF) domain score of the International Index of Erectile Function (IIEF)
Time Frame: pre-treatment and 2 weeks after treatment also, 3 and 6 months after treatment

Changes in the Erectile Function (EF) domain score of the International Index of Erectile Function (IIEF) between treatment periods and baseline in different study arms. the score as follow:

> 7 severe dysfunction 7-12 Moderate dysfunction

13-18 Mild to moderate dysfunction

19-24 Mild dysfunction

25-30 No dysfunction
pre-treatment and 2 weeks after treatment also, 3 and 6 months after treatment
the Sexual Event Profile (SEP) scores
Time Frame: baseline, 2 weeks post treatment , 3, and 6 months post treatment
Changes in the Sexual Event Profile (SEP) scores between treatment periods and baseline in different study arms by a <yes or no> response .
baseline, 2 weeks post treatment , 3, and 6 months post treatment
Global Assessment Questionnaire (GAQ) scores
Time Frame: baseline, 2 weeks post treatment , 3, and 6 months post treatment
Changes in the Global Assessment Questionnaire (GAQ) scores between treatment periods in different study arms by a <yes or no> response
baseline, 2 weeks post treatment , 3, and 6 months post treatment
Cavernosal artery peak systolic and end diastolic velocities
Time Frame: baseline, 2 weeks post treatment , 3, and 6 months post treatment
Change in Peak systolic velocity in the Cavernosal arteries, on color Doppler examination, in the patient and control groups.
baseline, 2 weeks post treatment , 3, and 6 months post treatment

Collaborators and Investigators

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

Sponsor

Benha University

Collaborators

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)

July 12, 2016

Primary Completion (Actual)

January 25, 2019

Study Completion (Actual)

February 20, 2019

Study Registration Dates

First Submitted

November 13, 2017

First Submitted That Met QC Criteria

November 28, 2017

First Posted (Actual)

November 29, 2017

Study Record Updates

Last Update Posted (Actual)

November 26, 2019

Last Update Submitted That Met QC Criteria

November 24, 2019

Last Verified

November 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 19-09-2016

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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