Phase 2
N=380
Safety and Efficacy Study of Botulinum Toxin Type A to Treat Lower Urinary Symptoms Due to Benign Prostatic Hyperplasia
Benign Prostatic Hyperplasia
Bottom Line
View on ClinicalTrials.gov: NCT00284518 ↗Enrolled (actual)
380
Serious AEs
12.3%
Results posted
Dec 2012
Primary outcome: Primary: Change From Baseline in International Prostate Symptom Score (IPSS) at Week 12 — 21.3; 20.2; 21.5; 20.7 Score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- botulinum toxin Type A (Biological); normal saline (Drug)
- Age
- Adult, Older Adult · 50+ yrs
- Sex
- Male
- Sponsor
- Allergan
- Primary completion
- May 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in International Prostate Symptom Score (IPSS) at Week 12 |
21.3; 20.2; 21.5; 20.7; -5.6; -6.3 | — |
| SECONDARY Change From Baseline in International Prostate Symptom Score (IPSS) at Week 72 |
21.3; 20.2; 21.5; 20.7; -5.0; -4.1 | — |
| SECONDARY Change From Baseline in Peak Urine Flow Rate |
10.4; 10.6; 9.6; 10.1; 1.8; 2.0 | — |
| SECONDARY Change From Baseline in Total Prostate Volume |
48.78; 48.40; 47.54; 47.23; -3.40; -3.65 | — |
| SECONDARY Change From Baseline in Transitional Zone Prostate Volume |
20.78; 21.75; 21.00; 20.73; -0.23; -0.76 | — |
| SECONDARY Change From Baseline in Post-Void Residual |
73.0; 69.7; 66.1; 64.3; 5.4; 10.9 | — |
Summary
The purpose of this study was to determine the safety and effectiveness of different doses of botulinum toxin Type A in treating lower urinary tract symptoms due to benign prostatic hyperplasia.
Eligibility Criteria
Inclusion Criteria
- Lower urinary tract symptoms due to benign prostatic hyperplasia
- Enlarged prostate volume by rectal ultrasound
Exclusion Criteria
- Previous prostate surgery
- Previous or current diagnosis of prostate cancer
- Use of other medications for the treatment of prostatic hyperplasia
- Urinary tract infection
Data sourced from ClinicalTrials.gov (NCT00284518). 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.