Botulinum Toxin Injection for the Management of BPH (MIST2)

April 13, 2020 updated by: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Intraprostatic Injection of Botulinum Toxin for the Management of Benign Prostatic Hyperplasia: A Randomized Phase II Trial

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

134

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Colorado
      • Denver, Colorado, United States, 80010
        • University of Colorado Health Sciences Center
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Northwestern University
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic
    • New York
      • New York, New York, United States, 10021
        • Cornell University
    • Texas
      • Dallas, Texas, United States, 75390
        • University of Texas Southwestern Medical Center
      • Houston, Texas, United States, 77030
        • Baylor College of Medicine
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53226
        • Medical College of Wisconsin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • 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 Names:
  • marketed in the US as BOTOX by Allergan

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Improvement in the AUA Symptom Score Index by 30% From Baseline Within the First 12 Weeks After Injection.
Time Frame: 12 weeks
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.
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborators

George Washington University

Investigators

  • Study Chair: Reginald Bruskewitz, MD, University of Wisconsin, Madison

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2006

Primary Completion (Actual)

June 1, 2009

Study Completion (Actual)

December 1, 2009

Study Registration Dates

First Submitted

March 21, 2007

First Submitted That Met QC Criteria

March 22, 2007

First Posted (Estimate)

March 23, 2007

Study Record Updates

Last Update Posted (Actual)

April 21, 2020

Last Update Submitted That Met QC Criteria

April 13, 2020

Last Verified

April 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MIST2
  • U01DK060817 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

Data are available at the NIDDK Central Repository https://repository.niddk.nih.gov/studies/mist2/?query=mist

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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