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Sponsored by: |
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) |
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Information provided by: | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) |
ClinicalTrials.gov Identifier: | NCT00451191 |
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 |
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Benign Prostatic Hyperplasia |
Drug: botulinum toxin type A (BoNT/A) |
Phase II |
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 |
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 |
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1: Active Comparator
100 units botulinum toxin type A (BoNT/A)
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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.
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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.
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Ages Eligible for Study: | 50 Years and older |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
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 |
Study Chair: | Reginald Bruskewitz, MD | University of Wisconsin, Madison |
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 |
benign prostatic hyperplasia BPH botulinum toxin BoNT/A |
Hyperplasia Botulinum Toxins Prostatic Diseases |
Prostatic Hyperplasia Botulinum Toxin Type A Genital Diseases, Male |
Pathologic Processes Anti-Dyskinesia Agents Therapeutic Uses Physiological Effects of Drugs |
Neuromuscular Agents Peripheral Nervous System Agents Central Nervous System Agents Pharmacologic Actions |