Botulinum Toxin Injection for the Management of BPH

NCT ID: NCT00451191

Last Updated: 2020-04-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 134 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-10-31
• Study Completion Date: 2009-12-31

Brief Summary

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.

Conditions

Benign Prostatic Hyperplasia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

1

100 units botulinum toxin type A (BoNT/A)

Group Type: ACTIVE_COMPARATOR

botulinum toxin type A (BoNT/A)

Intervention Type: DRUG

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

300 units botulinum toxin type A (BoNT/A)

Group Type: ACTIVE_COMPARATOR

botulinum toxin type A (BoNT/A)

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

Other Intervention Names

marketed in the US as BOTOX by Allergan

Eligibility 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.

• Minimum Eligible Age: 50 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

George Washington University

OTHER

Sponsor Role: collaborator

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

NIH

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Reginald Bruskewitz, MD

Role: STUDY_CHAIR

University of Wisconsin, Madison

Locations

University of Colorado Health Sciences Center

Denver, Colorado, United States

Northwestern University

Chicago, Illinois, United States

Mayo Clinic

Rochester, Minnesota, United States

Cornell University

New York, New York, United States

University of Texas Southwestern Medical Center

Dallas, Texas, United States

Baylor College of Medicine

Houston, Texas, United States

Medical College of Wisconsin

Milwaukee, Wisconsin, United States

Countries

United States

References

Crawford ED, Hirst K, Kusek JW, Donnell RF, Kaplan SA, McVary KT, Mynderse LA, Roehrborn CG, Smith CP, Bruskewitz R. Effects of 100 and 300 units of onabotulinum toxin A on lower urinary tract symptoms of benign prostatic hyperplasia: a phase II randomized clinical trial. J Urol. 2011 Sep;186(3):965-70. doi: 10.1016/j.juro.2011.04.062. Epub 2011 Jul 24.

Reference Type: RESULT

PMID: 21791356 (View on PubMed)

Other Identifiers

U01DK060817

Identifier Type: NIH

Identifier Source: secondary_id

View Link

MIST2

Identifier Type: -

Identifier Source: org_study_id

NCT00395525

Identifier Type: -

Identifier Source: nct_alias