NCT03355963

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

Completed Phase 2 Last updated 26 November 2019

What this trial tests

Phase 2 trial testing saline injection in Erectile Dysfunction in 200 participants. Completed in 20 February 2019.

Timeline

12 July 2016

Primary endpoint
25 January 2019

20 February 2019

Quick facts

Lead sponsor	Benha University
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	200
Start date	12 July 2016
Primary completion	25 January 2019
Estimated completion	20 February 2019

Drugs / interventions tested

• saline injection
• Botulinum toxin type A 50 units — full drug profile →
• Botulinum toxin type A 100 units — full drug profile →

Conditions studied

• Erectile Dysfunction — all drugs for Erectile Dysfunction →
• Botulinum Toxin — all drugs for Botulinum Toxin →

Sponsor

Benha University

Who can join

Adults 40 to 70, male only, with Erectile Dysfunction or Botulinum Toxin. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Safety and Efficacy of Intracavernosal Injections of AbobotulinumtoxinA (Dysport^®) as Add on Therapy to Phosphosdiesterase Type 5 Inhibitors or Prostaglandin E1 for Erectile Dysfunction-Case Studies.
   Giuliano F, Joussain C, Denys P. · · 2019 · cited 16× · PMID 31117236 · DOI 10.3390/toxins11050283