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Botulinum Toxin Injection for the Management of BPH (MIST2)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
ClinicalTrials.gov Identifier:
NCT00451191
First received: March 21, 2007
Last updated: June 20, 2013
Last verified: June 2013
  Purpose

This is a double-blind randomized phase II trial to determine whether two different doses of BoNT/A injection into the prostate gland demonstrate sufficient improvement in the management of lower urinary symptoms due to BPH to warrant more extensive research. Subjects will receive either a 100U or 300U dose. Participation will last 1 year.


Condition Intervention Phase
Benign Prostatic Hyperplasia
Drug: botulinum toxin type A (BoNT/A)
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Intraprostatic Injection of Botulinum Toxin for the Management of Benign Prostatic Hyperplasia: A Randomized Phase II Trial

Resource links provided by NLM:


Further study details as provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK):

Primary Outcome Measures:
  • Improvement in the AUA Symptom Score Index by 30% From Baseline Within the First 12 Weeks After Injection. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    The primary outcome was treatment success at 3 months post-treatment, defined as (1) improvement in the AUASI by at least 30% and/or (2) Qmax improvement of more than 30%, each determined from baseline to 3 months after injection. In addition, two safety criteria also had to be met; a dose failed if (1) any reported event was determined to be related to the onabotulinum toxin A injection and was considered life threatening, disabling, or fatal or (2) >=40% of the participants reported a moderate or severe side effect related to the botulinum toxin injection.


Enrollment: 134
Study Start Date: October 2006
Study Completion Date: December 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
100 units botulinum toxin type A (BoNT/A)
Drug: botulinum toxin type A (BoNT/A)
100 unit and 300 unit dosages: Dilute each 100 U vial with 1.3 ml of normal saline. Each reconstituted vial is then drawn up into a single syringe with a total of 4 ml = 300 U. The instrument used to inject the botulinum toxin is an ultrasound device with a transrectal ultrasound probe specially designed for prostate biopsies which has a special canal to introduce and direct a needle in to the selected prostatic area.
Other Name: marketed in the US as BOTOX by Allergan
Active Comparator: 2
300 units botulinum toxin type A (BoNT/A)
Drug: botulinum toxin type A (BoNT/A)
100 unit and 300 unit dosages: Dilute each 100 U vial with 1.3 ml of normal saline. Each reconstituted vial is then drawn up into a single syringe with a total of 4 ml = 300 U. The instrument used to inject the botulinum toxin is an ultrasound device with a transrectal ultrasound probe specially designed for prostate biopsies which has a special canal to introduce and direct a needle in to the selected prostatic area.
Other Name: marketed in the US as BOTOX by Allergan

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male at least 50 years of age.
  • Voided volume => 125 ml.
  • Maximum urinary flow < 15 ml/sec.
  • AUA symptom severity score => 8.
  • 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.

Exclusion Criteria:

  • Any prior surgical intervention for BPH.
  • Current diagnosis of acute or chronic prostatitis (which may cause LUTS that mimic BPH).
  • Overactive bladder without bladder outlet obstruction.
  • Enrolled in another treatment trial for any disease within the past 30 days.
  • Men interested in future fertility.
  • Previous exposure to botulinum toxin.
  • On alpha-blocker within the past 48 hours.
  • On any 5-alpha-reductase inhibitor within the past month.
  • Post void residual > 350 ml.
  • On phenylephrine, pseudoephedrine, imipramine, an anticholinergic, or cholinergic medication within the past 2 weeks.
  • On estrogen, androgen, any drug producing androgen suppression, or anabolic steroids within the past 4 months.
  • Clinically significant renal or hepatic impairment as determined by abnormal creatinine or AST levels (based on local institutional values).
  • Serum prostate specific antigen level > 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 biopsy, percent free PSA, or other clinical estimations in keeping with sound urologic care.
  • Active urinary tract disease or biopsy of the prostate within the past 6 weeks.
  • 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 bleeding diathesis.
  • Penile prosthesis or artificial urinary sphincter.
  • History or current evidence of carcinoma of the prostate or bladder, pelvic radiation 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.
  • Documented bacterial or acute prostatitis within the past year.
  • Two documented urinary tract infections of any type in the past year (UTI defined as > 100,000 colonies per ml urine from midstream clean catch or catheterized specimen).
  • History of bladder calculi.
  • Patients must be off aspirin, NSAIDS, and Coumadin for 7 or more days prior to botulinum toxin injection.
  • 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 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00451191

Locations
United States, Colorado
University of Colorado Health Sciences Center
Denver, Colorado, United States, 80010
United States, Illinois
Northwestern University
Chicago, Illinois, United States, 60611
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
United States, New York
Cornell University
New York, New York, United States, 10021
United States, Texas
University of Texas Southwestern Medical Center
Dallas, Texas, United States, 75390
Baylor College of Medicine
Houston, Texas, United States, 77030
United States, Wisconsin
Medical College of Wisconsin
Milwaukee, Wisconsin, United States, 53226
Sponsors and Collaborators
Investigators
Study Chair: Reginald Bruskewitz, MD University of Wisconsin, Madison
  More Information

No publications provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
ClinicalTrials.gov Identifier: NCT00451191     History of Changes
Obsolete Identifiers: NCT00395525
Other Study ID Numbers: MIST2, 5 U01 DK060817
Study First Received: March 21, 2007
Results First Received: June 20, 2013
Last Updated: June 20, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK):
benign prostatic hyperplasia
BPH
botulinum toxin
BoNT/A

Additional relevant MeSH terms:
Hyperplasia
Prostatic Hyperplasia
Genital Diseases, Male
Pathologic Processes
Prostatic Diseases
Botulinum Toxins
Botulinum Toxins, Type A
Anti-Dyskinesia Agents
Central Nervous System Agents
Neuromuscular Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014