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Safety and Efficacy of Botulinum Toxin Type A to Treat Lower Urinary Tract Symptoms Due to Benign Prostatic Hyperplasia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01107392
Recruitment Status : Completed
First Posted : April 21, 2010
Results First Posted : April 4, 2014
Last Update Posted : May 3, 2019
Sponsor:
Information provided by (Responsible Party):
Allergan

Study Description
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Brief Summary:
This study will evaluate the safety and efficacy of intraprostatic administration of botulinum toxin Type A (BOTOX®) compared with placebo to treat urinary tract symptoms due to benign prostatic hyperplasia.

Condition or disease Intervention/treatment Phase
Benign Prostatic Hyperplasia Drug: botulinum toxin Type A Drug: Normal saline Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 315 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Actual Study Start Date : August 1, 2010
Actual Primary Completion Date : March 16, 2012
Actual Study Completion Date : June 8, 2012

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Arms and Interventions
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Arm Intervention/treatment
Experimental: botulinum toxin Type A
botulinum toxin Type A total dose of 200U equally divided and administered to each lateral prostatic lobe.
 Drug: botulinum toxin Type A
botulinum toxin Type A total dose of 200U equally divided and administered to each lateral prostatic lobe.
Other Names:
  • BOTOX®
  • onabotulinumtoxinA
Placebo Comparator: Placebo (Normal saline)
Placebo (Normal saline) equally divided and administered to each lateral prostatic lobe.
 Drug: Normal saline
Placebo (Normal saline) equally divided and administered to each lateral prostatic lobe.


Outcome Measures
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Primary Outcome Measures :
  1. Change From Baseline in the Total International Prostate Symptom Score (IPSS) at Week 12 [ Time Frame: Baseline, Week 12 ]
    IPSS is a disease-specific outcome measure based on the American Urological Association Symptom Index. The questionnaire consisted of seven items. The patient evaluated their urinary symptoms (incomplete emptying, frequency, hesitancy, urgency, weak stream, straining, and nocturia) during the previous 4 weeks. The total symptom score ranged from 0 (no symptoms) to 35 (most severe symptoms). A negative change from Baseline indicated improvement.


Secondary Outcome Measures :
  1. Change From Baseline in the Total International Prostate Symptom Score (IPSS) [ Time Frame: Baseline, Week 6, Week 24 ]
    IPSS is a disease-specific outcome measure based on the American Urological Association Symptom Index. The questionnaire consisted of seven items. The patient evaluated their urinary symptoms (incomplete emptying, frequency, hesitancy, urgency, weak stream, straining, and nocturia) during the previous 4 weeks. The total symptom score ranged from 0 (no symptoms) to 35 (most severe symptoms). A negative change from Baseline indicated improvement.

  2. Change From Baseline in Peak Urine Flow Rate [ Time Frame: Baseline, Weeks 6, 12 and 24 ]
    Urinary flow was determined by uroflowmetry measured in milliliters/second (mL/sec). An increase from Baseline indicated improvement.

  3. Duration of Effect [ Time Frame: 24 Weeks ]
    Duration of effect was calculated from the time of the first follow-up visit with a ≥ 4-point reduction from Baseline in IPSS to the next visit when the IPSS change from Baseline was < 4-points.


Eligibility Criteria
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Ages Eligible for Study:   45 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Clinical enlargement of the prostate gland
  • Body weight ≥ 50 kg or 110 lbs

Exclusion Criteria:

  • History of chronic prostatitis
  • History of two or more urinary tract infections in the past year or one in the last 6 months
  • History of bladder stones
  • History of previous prostate surgery
  • History of bladder cancer or prostate cancer
  • Any previous or current usage of botulinum toxin therapy of any serotype for any urological condition
  • Botulinum toxin therapy of any serotype for any non-urological condition or usage (e.g., cosmetic) during the previous 12 weeks prior to study entry
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01107392


Locations
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United States, California
Newport Beach, California, United States
Canada, British Columbia
Surrey, British Columbia, Canada
Czechia
Praha, Czechia
France
Paris, France
Germany
Munich, Germany
Korea, Republic of
Seoul, Korea, Republic of
Philippines
Manila, Philippines
Poland
Poznan, Poland
Sponsors and Collaborators
Allergan
Investigators
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Study Director: Medical Director Allergan
More Information
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Publications:

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Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT01107392    
Other Study ID Numbers: 191622-100
First Posted: April 21, 2010    Key Record Dates
Results First Posted: April 4, 2014
Last Update Posted: May 3, 2019
Last Verified: April 2019
Additional relevant MeSH terms:
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Prostatic Hyperplasia
Hyperplasia
Pathologic Processes
Prostatic Diseases
Botulinum Toxins
Botulinum Toxins, Type A
abobotulinumtoxinA
Acetylcholine Release Inhibitors
 Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Neuromuscular Agents
Peripheral Nervous System Agents