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

NCT03355963 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2019-11-26

No results posted yet for this study

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

Interventions

OTHER

saline injection

The control group: received an IC 1 ml saline injection 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.

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.

Sponsors & Collaborators

  • Cairo University

    collaborator OTHER

  • Benha University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
70 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-07-12
Primary Completion
2019-01-25
Completion
2019-02-20

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03355963 on ClinicalTrials.gov