Phase 3
N=70
Botulinum Toxin for Erectile Dysfunction
Sexual Dysfunction · Erectile Dysfunction
Bottom Line
View on ClinicalTrials.gov: NCT03102762 ↗Enrolled (actual)
70
Serious AEs
0.0%
Results posted
Dec 2019
Primary outcome: Primary: Right (PSV R) and Left (PSV L) Cavernosal Artery Mean PSV Before Treatment — 34.52; 30.85; 34.33; 31.73 cm/sec
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Botulinum Toxin Type A (Drug); Normal saline (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Male
- Sponsor
- Cairo University
- Primary completion
- Jan 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Right (PSV R) and Left (PSV L) Cavernosal Artery Mean PSV Before Treatment |
34.52; 30.85; 34.33; 31.73 | — |
| PRIMARY Right (PSV R) and Left (PSV L) Cavernosal Artery Mean PSV After Treatment |
45.68; 31.67; 46.015; 32.09 | — |
| SECONDARY SHIM Score Before Treatment |
5.4; 5.69 | — |
| SECONDARY SHIM Score After Treatment |
9.97; 5.77; 8.26; 5.57 | — |
| SECONDARY SHIM Score After Treatment |
9.97; 5.77; 8.26; 5.57 | — |
| SECONDARY Penile Size Before Treatment |
10.17; 10.99; 13.36; 13.4; 14.17; 14.01 | — |
| SECONDARY Penile Size After Treatment |
10.54; 10.99; 13.46; 13.4; 10.46; 10.99 | — |
| SECONDARY Penile Size After Treatment |
10.54; 10.99; 13.46; 13.4; 10.46; 10.99 | — |
| SECONDARY Intra-vaginal Latency Time Before Treatment |
12; 9; 13; 18; 10; 8 | — |
| SECONDARY Intra-vaginal Latency Time After Treatment |
9; 8; 15; 19; 10; 8 | — |
| SECONDARY Intra-vaginal Latency Time After Treatment |
9; 8; 15; 19; 10; 8 | — |
Summary
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT03102762). 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.