Gusatavo E. Ayala, MD, University of Texas Houston Health Science Center
BOTOX in Men With Prostate Cancer With Lower Urinary Tract Symptoms(LUTS)/Benign Prostatic Hyperplasia (BPH)
Benign Prostatic Hyperplasia
Enlarged Prostate With Lower Urinary Tract Symptoms (LUTS)
This is a pilot study examining biological endpoints in men with localized prostate cancer
who are scheduled to have radical prostatectomies and men with Benign Prostatic
Hyperplasia/Lower Urinary Tract Symptoms (BPH/LUTS) following botulinum toxin type A
(BoNT-A) injection. Patients will serve as their own controls by receiving BoNT-A injections
into the right peripheral and transition zones and sham saline injections into the left
peripheral and transition zones.
Ages Eligible: 50 Years
Accepts Healthy Volunteers:
Biopsy proven, clinically localized prostate cancer
Low risk for recurrence defined as a Kattan nomogram score of less than 115, or a
serum PSA < 10ng/ml, or an individual Gleason grade of 3 or lower, or clinical stage
T2b or below.
Candidates diagnosed with localized prostate cancer must have agreed to radical
Voided volume greater than or equal to 125 ml.
Maximum urinary flow less than 15 ml/sec.
American Urological Association (AUA) symptom severity score greater than or equal to
Patient signed informed consent prior to the performance of any study procedures.
Patient able to complete the study protocol in the opinion of the investigator.
Any prior surgical intervention for BPH.
Current diagnosis of acute or chronic prostatitis (which may cause LUTS that mimic
History of bladder stones.
Overactive bladder without bladder outlet obstruction.
Enrolled in another treatment trial for any disease within the past 30 days.
Previous exposure to botulinum toxin.
Post void residual greater than 350 ml.
Clinically significant renal or hepatic impairment as determined by abnormal
creatinine or AST levels (based on local institutional values).
Daily use of a pad or device for incontinence required.
Episode of unstable angina pectoris, myocardial infarction, transient ischemic
attack, or cerebrovascular accident (stroke) within the past 6 months.
On aminoglycosides or any drug that interfere with neuromuscular transmission.
Eaton-Lambert syndrome, hemophilia, hereditary clotting factors deficiency, or
Penile prosthesis or artificial urinary sphincter.
History or current evidence of carcinoma of the bladder; pelvic radiation, hormonal
treatment or surgery; urethral stricture; or bladder neck obstruction.
Known primary neurologic conditions such as multiple sclerosis, myasthenia gravis or
Parkinson's disease, or other neurological diseases known to affect bladder function.
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
Patients must be off aspirin, non-steroidal anti-inflammatory drugs (NSAIDS), and
Coumadin for 7 or more days prior to botulinum toxin injection.
Any serious medical condition likely to impede successful completion of the study,
such as certain mental disorders, hypersensitivity to botulinum toxin or anesthetics
used in the study, syncope, uncontrolled diabetes.
Patients will be excluded if they have depressed hematopoietic functions (platelet
count <100,000/cm3, hemoglobin <8,5 mg/dl; absolute neutrophil count <1000/cm3).
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Information obtained from ClinicalTrials.gov, on
7/30/2015. For additional information about
this and other clinical trials,
Please refer to this study by its ClinicalTrials.gov identifier: