Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials
Trial record 1 of 63 for:    MIST2
Previous Study | Return to List | Next Study

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
Results First Received: June 20, 2013  
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
Condition: Benign Prostatic Hyperplasia
Intervention: Drug: botulinum toxin type A (BoNT/A)

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Patients were recruited at the 7 clinical centers (Baylor College of Medicine, Houston TX; Cornell University, New York NY; Mayo Clinic, Rochester MN; Medical College of Wisconsin, Milwaukee WI; Northwestern University, Chicago IL; University of Colorado Denver, Aurora CO; University of Texas Southwestern Medical Center, Dallas TX).

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Screening for eligibility: male, 50+ years old, signed informed consent, no prior surgical treatment for BPH and no prior use of botulinum toxin, appropriate washout period for medical therapy, American Urological Association Symptom Index (AUASI) >=8, voided volume >=125 ml, maximum urinary flow rate <15 ml/sec.

Reporting Groups
  Description
100 Units Botulinum Toxin Type A 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.
300 Units Botulinum Toxin Type A 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.

Participant Flow:   Overall Study
    100 Units Botulinum Toxin Type A     300 Units Botulinum Toxin Type A  
STARTED     68     66  
COMPLETED     53     55  
NOT COMPLETED     15     11  
withdrawal or received alternate tx                 15                 11  



  Baseline Characteristics
  Hide Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
100 Units Botulinum Toxin Type A 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.
300 Units Botulinum Toxin Type A 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.
Total Total of all reporting groups

Baseline Measures
    100 Units Botulinum Toxin Type A     300 Units Botulinum Toxin Type A     Total  
Number of Participants  
[units: participants]
  68     66     134  
Age, Customized  
[units: participants]
     
<50 years     0     0     0  
>=50 years     68     66     134  
Gender  
[units: participants]
     
Female     0     0     0  
Male     68     66     134  
Region of Enrollment  
[units: participants]
     
United States     68     66     134  



  Outcome Measures

1.  Primary:   Improvement in the AUA Symptom Score Index by 30% From Baseline Within the First 12 Weeks After Injection.   [ Time Frame: 12 weeks ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
First, this study was not designed to compare the effect of onabotulinum toxin A to placebo. Second, we assessed our primary outcome, treatment efficacy, at 3 months post-injection. The long-term safety of this product should also be evaluated.


  More Information
  Hide More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Kathryn Hirst, PhD, Research Professor, PI of coordinating center
Organization: George Washington University Biostatistics Center
phone: 301-881-9260 ext 8025
e-mail: khirst@bsc.gwu.edu


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

Publications automatically indexed to this study:

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