BOTOX versus Flomax for BPH and LUTS (H-27457)
OnabotulinumtoxinA (onaBoNT-A) vs Oral Tamsulosin for BPH & LUTS (#02-10-10-05)
Benign prostatic hyperplasia (BPH) with its related symptoms is a common condition that affects nearly half of men over age 50 and 90 percent of men over 80. Lower urinary tract symptoms (LUTS) caused by BPH, which include nocturia (excessive urinating at night), frequency, urgency, hesitancy, intermittency and incomplete emptying, can be very bothersome, affect an individual’s lifestyle significantly, and are costly. This study is a clinical research study that is conducted under the FDA (Food and Drug Administration). The onaBoNT-A has been approved for use in humans for other problems but not for prostate problems. The main purpose of the study is to compare the effectiveness of 200 U onaBoNT-A injected into the prostate versus oral tamsulosin for the treatment of lower urinary tract symptoms caused by BPH. Changes in the prostate tissue that is removed during the prostate biopsies will also be compared.
The study medications for this study are onaBoNT-A injection, placebo injection, oral (by mouth) tamsulosin (Flomax) and placebo oral drug. For this study, the placebo injection is saline (salt water) and the oral drug is a look-alike pill that contains no medicine. You will be in ARM 1 (onaBoNT-A injection and placebo capsule that is taken every day by mouth) or ARM 2 (placebo (salt water) injection and a tamsulosin 0.4 mg capsule taken every day by mouth).
You will have five clinic visits and two telephone visits during this study. Your participation in the study will be about four to five months. During your participation in the study, you will have physical exams including a digital rectal examination (DRE), urine flow tests, blood and urine tests, and prostate biopsies.
You must be a male veteran seen at the VA-Houston Urology clinic who is at least 50 years of age. Your urine flow test results that need to be within approved ranges. You must not have had any prior surgical or medical treatment for BPH. You may not have acute or chronic prostate disease. Uncontrolled diabetes. There are other reasons you may not be able to participate.