Effectiveness of onaBoNT-A vs Oral Tamsulosin in Men With Benign Prostatic Hyperplasia and Lower Urinary Track Symptoms (BPH)
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.
Benign Prostatic Hyperplasia
Lower Urinary Track Symptoms
Drug: onaBoNT-A + placebo
Drug: Tamsulosin + placebo
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
|Official Title:||OnabotulinumtoxinA (onaBoNT-A) vs Oral Tamsulosin for BPH & LUTS (#02-10-10-05)|
- American Urologic Association Symptom Score (AUASS) [ Time Frame: 3 months ] [ Designated as safety issue: No ]Analysis will begin with descriptive statistics. Implausible and missing values will be identified and double-checked for accuracy. Parametric methodology will be used unless measurements have tested positive for violation of normality assumption. The differences between the study subjects groups will be evaluated using the paired-samples t-tests. The clinical outcomes will be compared using Fisher's test. The criterion for significance (alpha) has been set at 0.05. All tests are 2-tailed, which means that an effect in either direction will be interpreted.
|Study Start Date:||June 2012|
|Estimated Study Completion Date:||June 2016|
|Estimated Primary Completion Date:||January 2016 (Final data collection date for primary outcome measure)|
Active Comparator: ARM 1: onaBoNT-A + placebo
onaBoNT-A 200 U prostate injection and placebo oral capsule daily
Drug: onaBoNT-A + placebo
200 U prostate injection once
Arms: ARM 1: onaBoNT-A + placebo
Other Name: Botox
Active Comparator: ARM 2: Saline + Tamsulosn
Placebo prostate injection (saline) and tamsulosin 0.4 mg capsule daily.
Drug: Tamsulosin + placebo
0.4 mg capsule daily for 3 months Arms: ARM 2: Saline + Tamsulosn
Other Name: Flomax
This proposed intervention is the first randomized clinical trial comparing the effects of onaBoNT-A prostate injection versus alpha adrenergic antagonist medication for LUTS associated with BPH. Up to this point, clinical studies using onaBoNT-A in the prostate has been limited to patient's refractory to -1 adrenoceptor blocker therapy. The study will directly compare onaBoNT-A against -1 adrenoceptor blockers as frontline therapy in a male veteran cohort suffering from moderate to severe LUTS. Besides its obvious efficacy in patients' refractory to -1 adrenoceptor blocker therapy, onaBoNTA injection has several potential advantages over oral agents. Focal prostate injection has been shown to be safe and obviates the systemic side effects observed with -1 adrenoceptor blockers (i.e. orthostatic hypotension, sexual dysfunction). In addition, most clinical studies demonstrate a durable response to onaBoNT-A treatment exceeding 12 months. Although this study is of modest length (i.e. total 4 years), significant results could drive paradigm shifts in how LUTS associated with BPH is treated, even with regards to frontline therapy.
Although sophisticated molecular techniques (i.e. LCM with Microarray Analysis) have been used by other investigators to characterize gene profile changes with BPH and LUTS, this will be the first study examining gene profile changes in drug na ve BPH View Protocol Record patients following treatment with the -1 adrenoceptor blocker Tamsulosin or onaBoNT-A. This study is important because scant knowledge exists on the true mechanisms by which -1 adrenoceptor blockers like Tamsulosin or onaBoNT-A improve patient urinary tract symptoms and quality of life. It is clear, however, that nerves not only regulate prostate growth and function but also account for LUTS that drive patients to seek therapy. This investigation will utilize onaBoNT-A as a biological tool to identify potential novel mechanistic pathways for future investigation that will push the development of targeted therapy to benefit those patients refractory to all pharmacologic treatment. Potential inflammatory pathways or neural sensory signaling alterations induced by BPH, which are modified by onaBoNT-A or Tamsulosin to improve symptoms via gene profile changes, can be explored by expert laboratories in the Texas Medical Center. This is a highly collaborative project utilizing expertise across departments that will foster translational work from the laboratory to the patient. Although not the primary goal of this study, the investigators will also search for possible biological markers with prognostic value that could be confirmed in a future multi-center trial.
The primary objective of this Phase 2 clinical research study is to compare the efficacy of 200 U onaBoNT-A injected into the prostate versus oral tamsulosin for the treatment of lower urinary tract symptoms caused by BPH in male veteran volunteers at the MEDVAMC. The secondary objective is to determine the impact of tamsulosin and onaBoNT-A on the pathologic parameters and RNA profiles of epithelium and stroma in BPH tissues.
Volunteers will be randomized into two groups with one receiving ona-BoNT-A injection into the prostate and an oral placebo pill taken once daily and the other group will receive a placebo injection and an oral tamsulosin pill once daily.
Volunteers will make five clinic visits and be contacted by telephone twice
Please refer to this study by its ClinicalTrials.gov identifier: NCT01589263
|Contact: Sebrina A Tello||(713) 791-1414 ext 5326||Sebrina.Tello@va.gov|
|Contact: Christopher P Smith, MD||(713) 791-1414||ChristopherP.Smith@va.gov|
|United States, Texas|
|Michael E. DeBakey VA Medical Center, Houston, TX||Recruiting|
|Houston, Texas, United States, 77030|
|Contact: Christopher P Smith, MD 713-791-1414 ChristopherP.Smith@va.gov|
|Principal Investigator: Christopher P. Smith, MD|
|Principal Investigator:||Christopher P. Smith, MD||Michael E. DeBakey VA Medical Center, Houston, TX|