Effectiveness of onaBoNT-A vs Oral Tamsulosin in Men With BPH and LUTS
Status:
Completed
Trial end date:
2019-09-30
Target enrollment:
Participant gender:
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.