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

NCT03355963 | Completed Phase 2

• 1 other identifier: 19-09-2016
• Study Type: interventional
• Target: 200
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Erectile Dysfunction; Botulinum Toxin

Outcome Measures

Primary Outcomes (4)

• Erectile Function (EF) domain score of the International Index of Erectile Function (IIEF)

  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

  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

  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

  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

Study Arms (3)

Group A

PLACEBO COMPARATOR

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

Other: saline injection

Group B

ACTIVE COMPARATOR

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

Group C

ACTIVE COMPARATOR

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

Interventions

saline injection OTHER

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

Also known as: group A (control group)

Group A

Botulinum toxin type A 50 units BIOLOGICAL

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

Also known as: group B

Group B

Botulinum toxin type A 100 units BIOLOGICAL

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

Also known as: group C

Group C

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Benha University: lead
• Cairo University: collaborator

MeSH Terms

Conditions

Erectile Dysfunction

Interventions

Sodium Chloride; Control Groups

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds; Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 13, 2017
• First Posted: November 29, 2017
• Study Start: July 12, 2016
• Primary Completion: January 25, 2019
• Study Completion: February 20, 2019
• Last Updated: November 26, 2019

Record last verified: 2019-11