Effectiveness of onaBoNT-A vs Oral Tamsulosin in Men With BPH and LUTS
Condition: Benign Prostatic Hyperplasia; Lower Urinary Track Symptoms
MeSH terms: Prostatic Hyperplasia; Hyperplasia
Intervention: onaBoNT-A + placebo; Tamsulosin + placebo
Intervention description: 200 U prostate injection once
Arms: ARM 1: onaBoNT-A + placebo; 0.4 mg capsule daily for 3 months Arms: ARM 2: Saline + Tamsulosin
Intervention MeSH terms: Tamsulosin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 63.0
Sex: Male
Minimum age: 50 Years
Healthy volunteers: No
Keywords: Benign Prostatic Hyperplasia; Lower Urinary Track Symptoms; BPH; LUTS

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.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Males at least 50 years of age

          -  American Urological Association Symptom Score greater than 8

          -  Voided volume greater than 125 ml

          -  Maximum urinary flowrate less than 15 ml/sec.

          -  Must agree to all procedures and willfully consented

        Exclusion Criteria:

          -  Any prior surgical intervention or use of 5-alpha-reductase medical intervention for
             BPH

          -  Current diagnosis of acute or chronic prostatitis (which may cause LUTS that mimic
             BPH)

          -  Previous exposure to onabotulinumtoxinA

          -  Overactive bladder without obstructive symptoms (i.e. decrease in force of stream,
             hesitancy, intermittency, post-void dribbling)

          -  Active urinary tract disease or biopsy of the prostate within the past 6 weeks;

          -  Two documented urinary tract infections of any type in the past year (UTI defined as
             greater than 100,000 colonies per ml urine from midstream clean catch or catheterized
             specimen)

          -  Uncontrolled diabetes

          -  History of bladder calculi (stones)

          -  Penile prosthesis or artificial urinary sphincter [placement]

          -  Documented bacterial or acute prostatitis within the past year

          -  Episode of unstable angina pectoris, myocardial infarction, transient ischemic attack,
             or cerebrovascular accident (stroke) within the past 6 months

          -  Known primary neurologic conditions such as multiple sclerosis, myasthenia gravis or
             Parkinson's disease, or other neurological diseases known to affect bladder function

          -  History or current evidence of carcinoma of the prostate or bladder, pelvic radiation
             or surgery, urethral stricture, or bladder neck obstruction

          -  Cancer that is not considered cured, except basal cell or squamous cell carcinoma of
             the skin (cured defined as no evidence of cancer within the past 5 years)

          -  Any serious medical condition that is likely to impede successful completion of the
             study, such as certain mental disorders, hypersensitivity to onabotulinumtoxinA or
             anesthetics used in the study, syncope

          -  Daily use of a pad or device for incontinence required

          -  Interested in future fertility

          -  Postvoid Residual (PVR) greater than 350 ml

          -  Serum prostate specific antigen (PSA) level greater than 8 ng/ml (Hybritech). For
             those with a PSA between 4-8 ng/ml, the PSA elevation must be considered to be from a
             benign cause in the opinion of the PI. This decision can be based on PSA velocity,
             previous TRUS (transrectal ultrasound) biopsy, percent free PSA, or other clinical
             estimations in keeping with sound urologic care

          -  Has taken phenylephrine, pseudoephedrine, imipramine, an anticholinergic, or
             cholinergic medication within the past 2 weeks

          -  Has taken estrogen, androgen, any drug producing androgen suppression, or anabolic
             steroids within the past 4 months

          -  Taking aminoglycosides or any drug that interfere with neuromuscular transmission.
             Eaton-Lambert syndrome, hemophilia, hereditary clotting factors deficiency, or
             bleeding diathesis

          -  Must be off aspirin, NSAIDS, and Coumadin for 7 or more days prior to
             onabotulinumtoxinA injection

          -  Enrolled in another treatment trial for any disease within the past 30 days