At a glance
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Effectiveness of OnabotulinumtoxinA (onaBoNT-A) vs Oral Tamsulosin in Men With Benign Prostatic Hyperplasia & Lower Urinary Track Symptoms (#02-10-10-05)
In Brief
A Phase 2 clinical trial evaluating onaBoNT-A + placebo and Tamsulosin + placebo for Benign Prostatic Hyperplasia and Lower Urinary Track Symptoms. Completed, enrolled 63 participants across 1 site.
Detailed Summary
Benign prostatic hyperplasia (BPH) and its related symptoms are a common condition that affects nearly half of men over age 50 and 90% of men over 80. Lower urinary tract symptoms (LUTS) caused by BPH can be very troublesome, affect an individual's quality of life significantly, and are costly. his Phase 2 clinical research trial is a double-blind, randomized, placebo-controlled, parallel-group study to compare the treatment effects of onaBoNT-A 200 U versus 0.4 mg per day of oral tamsulosin in male Veterans diagnosed with moderate to severe LUTS \[American Urologic Association Symptom Score (AUASS) equal to or greater than 8\] associated with BPH. A total of 74 volunteers will be recruited to participate in this clinical trial. Volunteers will include only males who are greater than 50 years of age and diagnosed with LUTS associated with BPH. They are Veterans who visit the Michael E. DeBakey Veterans Affairs Medical Center - Houston (MEDVAMC). There are no eligibility restrictions as to race or ethnicity.
Study Details
Timeline
Interventions
200 U prostate injection once Arms: ARM 1: onaBoNT-A + placebo
0.4 mg capsule daily for 3 months Arms: ARM 2: Saline + Tamsulosin