Phase 1
Completed N=24
Intracavernosal Injection of Botulinum Toxin Type A in the Treatment of Vascular Erectile Dysfunction
Vasculogenic Erectile Dysfunction
Source: ClinicalTrials.gov NCT02584686 ↗
Enrolled (actual)
24
Serious AEs
0.0%
Results posted
Oct 2016
Primary outcomePrimary: Cavernosal Artery Mean PSV Before Treatment — 24.5; 28.2 cm/s
Summary
Evidence has been arising that Botulinum toxin injections can relax smooth muscles fibers in the treatment of obesity and hyperactive bladder. Would a similar effect on cavernosal smooth muscles help in the treatment of resistant erectile dysfunction not responding to medical and injection therapy, thus avoiding surgical treatment options.
The treatment group will be injected intracavernously with 50 units of BTX-A. The control group, 12 patients, will be injected with a normal saline injection.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Cavernosal Artery Mean PSV Before Treatment |
24.5; 28.2 | — |
| PRIMARY Cavernosal Artery Mean PSV After Treatment |
34.0; 30.5 | 0.0049 sig |
| SECONDARY EHS Before Treatment |
2.08; 2.17 | — |
| SECONDARY EHS After Treatment |
2.75; 2.17 | 0.01086956 sig |
| SECONDARY SHIM Score Before Treatment |
5.58; 5.75 | — |
| SECONDARY SHIM Score After Treatment |
10.3; 6.67 | 0.00751288 sig |
| SECONDARY Global Assessment Question (GAQ) |
7; 1 | 0.027191 sig |
| SECONDARY SEP-Q2 Question Before Treatment |
0; 2 | — |
| SECONDARY SEP-Q2 Question After Treatment |
7; 2 | 0.109091 |
| SECONDARY SEP-Q3 Question Before Treatment |
0; 0 | — |
| SECONDARY SEP-Q3 Question After Treatment |
3; 1 | 1 |
Eligibility Criteria
Inclusion Criteria
- 24 males will be included in the study recruited from Andrology, Sexology & STD's outpatient clinic, Kasr El Aini Hospitals, Cairo University, complaining of Vascular ED proved by penile duplex.
- 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 40 to 70 years.
Exclusion Criteria
- Significant cardiovascular disease interfering with sexual activity
Data sourced from ClinicalTrials.gov (NCT02584686). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.