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NCT Number: NCT03102762

Botulinum Toxin for Erectile Dysfunction

To evaluate the safety and efficacy of intra-cavernosal Botulinum toxin injection as an alternative line of treatment in patients with erectile dysfunction - not responding to oral PDE5i - through cavernosal smooth muscle relaxation.

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Key information

Conditions

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

Age range

18 year–80 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Department of Andrology, Cairo University

Cairo, 11231, Egypt

About this study

The initial Phase 1 study demonstrated safety and efficacy of Botulinum toxin type A in the treatment of Erectile dysfunction in a small randomized controlled trial of 24 men.

The investigators conduct a phase 2 trial to confirm the initial results in a larger group of men.70 males will be included in the study. The participants will be subjected for full history taking, general and genital examination. Penile duplex will be performed to assess a vascular etiology before the treatment and 2 weeks later. The patients will be randomized into a treatment group (35 patients) and a control group (35 patients).

All patients will sign an informed consent. The treatment group will be injected IC with a trimix solution (20 ug alprostadil + 1 mg phentolamine + 30 mg papaverine) for color Doppler assessment, followed, next day by 50 units of BTX-A. The control group will be injected with the trimix solution during penile color Doppler assessment followed next day with a normal saline injection. The erection hardness score (EHS) will be assessed during the Doppler exam.

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 100 units of BTX-A. 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 the Sexual Encounter Profile questions 1 and 2 (SEP 2 & SEP 3), and the global assessment question (GAQ) before and 4 weeks after treatment.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 70 males will be included in the study recruited from Andrology, Sexology & STD's outpatient clinic, Kasr El Aini Hospitals, Cairo University, complaining of ED.
  • 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 18 to 80 years.

Exclusion criteria

  • Significant cardiovascular disease interfering with sexual activity

Treatment and study plan

Botulinum Toxin Type A

Drug

Drug: Botulinum Toxin Type A The treatment group will be injected with 100 units BTX-A one day following penile colour doppler assessment.

normal saline

Drug

The treatment group will be injected with 1 ml normal saline one day following penile colour doppler assessment.

Primary outcomes

  1. Right (PSV R) and Left (PSV L) Cavernosal Artery Mean PSV Before Treatment

    Time frame: Baseline

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

  2. Right (PSV R) and Left (PSV L) Cavernosal Artery Mean PSV After Treatment

    Time frame: 2 weeks

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

Secondary outcomes

  1. SHIM Score Before Treatment

    Time frame: Baseline

    Assessment of the Sexual Health Inventory for men (SHIM) questionnaire before treatment for both groups. It is a questionnaire that helps asses if the patient has erectile dysfunction (ED) and assesses its degree. Results range from 1 to 25. A score of 1-7 denotes Severe ED, 8-11 Moderate ED, 12-16, Mild to Moderate ED, 17-21 Mild ED, 22-25 No ED.

  2. SHIM Score After Treatment

    Time frame: 2 weeks after injection.

    Assessment of the Sexual Health Inventory for men (SHIM) questionnaire after treatment for both groups. It is a questionnaire that helps to asses if the patient has erectile dysfunction (ED) and to assess its degree. Results range from 1 to 25. A score of 1-7 denotes Severe ED, 8-11 Moderate ED, 12-16, Mild to Moderate ED, 17-21 Mild ED, 22-25 No ED.

    Minimum value is 1, Maximum value is 25, the higher the score the better is the outcome.

  3. SHIM Score After Treatment

    Time frame: 6 and 12 weeks after injection.

    Assessment of the Sexual Health Inventory for men (SHIM) questionnaire after 6 and 12 weeks of both groups. It is a questionnaire that helps to asses if the patient has erectile dysfunction (ED) and to assess its degree. Results range from 1 to 25. A score of 1-7 denotes Severe ED, 8-11 Moderate ED, 12-16, Mild to Moderate ED, 17-21 Mild ED, 22-25 No ED.

    Minimum value is 1, Maximum value is 25, the higher the score the better is the outcome.

  4. Penile Size Before Treatment

    Time frame: Baseline

    Measurement of penile length before treatment:

    Flaccid, stretched and erect penile length.

  5. Penile Size After Treatment

    Time frame: 2 weeks after injection.

    Measurement of penile length after treatment.

  6. Penile Size After Treatment

    Time frame: 6 and 12 weeks after injection.

    Measurement of penile length after treatment.

  7. Intra-vaginal Latency Time Before Treatment

    Time frame: Baseline

    Measurement of the duration of intercourse from intromission to ejaculation before treatment.

  8. Intra-vaginal Latency Time After Treatment

    Time frame: 2 weeks after injection.

    Measurement of the duration of intercourse from intromission to ejaculation after treatment.

  9. Intra-vaginal Latency Time After Treatment

    Time frame: 6 and 12 weeks after injection.

    Measurement of the duration of intercourse from intromission to ejaculation after treatment.

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

Intracavernosal Injection of Botulinum Toxin Type A in the Treatment of Erectile Dysfunction (Phase 2 Study)

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Apr 6, 2017
Registry last updated
Jan 7, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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