Full Text View  
  Tabular View  
  Contacts and Locations  
  No Study Results Posted  
  Related Studies  
Botulinum Toxin Injection for the Management of BPH (MIST2)
This study is currently recruiting participants.
Verified by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), June 2008
Sponsored by: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
ClinicalTrials.gov Identifier: NCT00451191
  Purpose

This is a double-blind randomized 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 II

MedlinePlus related topics: Botox
Drug Information available for: Sodium chloride Clostridium botulinum toxin
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Dose Comparison, Parallel Assignment, Safety/Efficacy Study
Official Title: Intraprostatic Injection of Botulinum Toxin for the Management of Benign Prostatic Hyperplasia: A Randomized Phase II Trial

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 ]
  • Qmax improvement of more than 30% from baseline within the first 12 weeks after injection. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Evidence of toxicity and side effects [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  • Durability of effects [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Improvement in urinary frequency [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Prostate volume change from baseline [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Post-void residual urine [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 126
Study Start Date: October 2006
Estimated Study Completion Date: June 2008
Estimated Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Active Comparator
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.
2: Active Comparator
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.

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

Locations
United States, Colorado
University of Colorado Health Sciences Center Recruiting
Denver, Colorado, United States, 80010
Contact: Patti DeVore     720-848-1386     patricia.devore@uchsc.edu    
Principal Investigator: David Crawford, MD            
United States, Illinois
Northwestern University Recruiting
Chicago, Illinois, United States, 60611
Contact: Maria Velez     312-908-5396     m-manzera@northwestern.edu    
Principal Investigator: Kevin McVary, MD            
United States, Minnesota
Mayo Clinic Recruiting
Rochester, Minnesota, United States, 55905
Contact: Jane Smith     507-284-3369     smith.jane2@mayo.edu    
Contact: Carol Van Oort     507-284-3369     vanoort.carol@mayo.edu    
Principal Investigator: Michael Lieber, MD            
Sub-Investigator: Lance Mynderse, MD            
United States, New York
Cornell University Recruiting
New York, New York, United States, 10021
Contact: Celeste Egan     212-746-1626     cae2005@med.cornell.edu    
Principal Investigator: Steven Kaplan, MD            
Sub-Investigator: Alexis E Te, MD            
United States, Texas
Baylor College of Medicine Recruiting
Houston, Texas, United States, 77030
Contact: Sharon Harrison     713-798-8517     Sharriso@www.urol.bcm.tmc.edu    
Principal Investigator: Christopher Smith, MD            
University of Texas Southwestern Medical Center Recruiting
Dallas, Texas, United States, 75390
Contact: Allison Beaver, RN     214-645-8788     Allison.Beaver@UTSouthwestern.edu    
Principal Investigator: Claus Roehrborn, MD            
United States, Wisconsin
Medical College of Wisconsin Not yet recruiting
Milwaukee, Wisconsin, United States, 53226
Contact: Maria Pigsley     414-456-6978     mpigsley@mail.mcw.edu    
Principal Investigator: Robert Donnell, MD            
Sponsors and Collaborators
Investigators
Study Chair: Reginald Bruskewitz, MD University of Wisconsin, Madison
  More Information

Responsible Party: George Washington University Biostatistics Center ( Kathryn Hirst/Coordinating Center Principal Investigator )
Study ID Numbers: MIST2, 5 U01 DK060817
Study First Received: March 21, 2007
Last Updated: June 19, 2008
ClinicalTrials.gov Identifier: NCT00451191  
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

Study placed in the following topic categories:
Hyperplasia
Botulinum Toxins
Prostatic Diseases
Prostatic Hyperplasia
Botulinum Toxin Type A
Genital Diseases, Male

Additional relevant MeSH terms:
Pathologic Processes
Anti-Dyskinesia Agents
Therapeutic Uses
Physiological Effects of Drugs
Neuromuscular Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 14, 2009