Back to resultsSafety and Efficacy of Botulinum Toxin Type A to Treat Lower Urinary Tract Symptoms Due to Benign Prostatic Hyperplasia
Primary Purpose
Benign Prostatic Hyperplasia
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
botulinum toxin Type A
Normal saline
Sponsored by
About this trial
This is an interventional treatment trial for Benign Prostatic Hyperplasia
Eligibility 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
botulinum toxin Type A
Placebo (Normal saline)
Arm Description
botulinum toxin Type A total dose of 200U equally divided and administered to each lateral prostatic lobe.
Placebo (Normal saline) equally divided and administered to each lateral prostatic lobe.
Outcomes
Primary Outcome Measures
Change From Baseline in the Total International Prostate Symptom Score (IPSS) at 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
Change From Baseline in the Total International Prostate Symptom Score (IPSS)
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.
Change From Baseline in Peak Urine Flow Rate
Urinary flow was determined by uroflowmetry measured in milliliters/second (mL/sec). An increase from Baseline indicated improvement.
Duration of Effect
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01107392
Brief Title
Safety and Efficacy of Botulinum Toxin Type A to Treat Lower Urinary Tract Symptoms Due to Benign Prostatic Hyperplasia
Study Type
Interventional
2. Study Status
Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
August 1, 2010 (Actual)
Primary Completion Date
March 16, 2012 (Actual)
Study Completion Date
June 8, 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Allergan
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Benign Prostatic Hyperplasia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
315 (Actual)
8. Arms, Groups, and Interventions
Arm Title
botulinum toxin Type A
Arm Type
Experimental
Arm Description
botulinum toxin Type A total dose of 200U equally divided and administered to each lateral prostatic lobe.
Arm Title
Placebo (Normal saline)
Arm Type
Placebo Comparator
Arm Description
Placebo (Normal saline) equally divided and administered to each lateral prostatic lobe.
Intervention Type
Drug
Intervention Name(s)
botulinum toxin Type A
Other Intervention Name(s)
BOTOX®, onabotulinumtoxinA
Intervention Description
botulinum toxin Type A total dose of 200U equally divided and administered to each lateral prostatic lobe.
Intervention Type
Drug
Intervention Name(s)
Normal saline
Intervention Description
Placebo (Normal saline) equally divided and administered to each lateral prostatic lobe.
Primary Outcome Measure Information:
Title
Change From Baseline in the Total International Prostate Symptom Score (IPSS) at Week 12
Description
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.
Time Frame
Baseline, Week 12
Secondary Outcome Measure Information:
Title
Change From Baseline in the Total International Prostate Symptom Score (IPSS)
Description
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.
Time Frame
Baseline, Week 6, Week 24
Title
Change From Baseline in Peak Urine Flow Rate
Description
Urinary flow was determined by uroflowmetry measured in milliliters/second (mL/sec). An increase from Baseline indicated improvement.
Time Frame
Baseline, Weeks 6, 12 and 24
Title
Duration of Effect
Description
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.
Time Frame
24 Weeks
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Director
Organizational Affiliation
Allergan
Official's Role
Study Director
Facility Information:
City
Newport Beach
State/Province
California
Country
United States
City
Surrey
State/Province
British Columbia
Country
Canada
City
Praha
Country
Czechia
City
Paris
Country
France
City
Munich
Country
Germany
City
Seoul
Country
Korea, Republic of
City
Manila
Country
Philippines
City
Poznan
Country
Poland
12. IPD Sharing Statement
Citations:
PubMed Identifier
24508634
Citation
McVary KT, Roehrborn CG, Chartier-Kastler E, Efros M, Bugarin D, Chen R, Patel A, Haag-Molkenteller C. A multicenter, randomized, double-blind, placebo controlled study of onabotulinumtoxinA 200 U to treat lower urinary tract symptoms in men with benign prostatic hyperplasia. J Urol. 2014 Jul;192(1):150-6. doi: 10.1016/j.juro.2014.02.004. Epub 2014 Feb 7. Erratum In: J Urol. 2015 Jan;193(1):374.
Results Reference
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Safety and Efficacy of Botulinum Toxin Type A to Treat Lower Urinary Tract Symptoms Due to Benign Prostatic Hyperplasia
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