drugset / Trial / NCT03355963

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

NCT03355963

Phase 2 Completed 200 enrolled Benha University Cairo University · collab
RandomizedParallel-groupDouble-blindTreatment

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.

Timeline

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

Drugs

EvaluationDrugModalityDoseRoute
Comparator Botulinum toxin type A Protein / enzyme biologic 50 iu Other
Comparator Botulinum toxin type A Protein / enzyme biologic 100 iu Other