Back to resultsSafety and Efficacy Study of Botulinum Toxin Type A to Treat Lower Urinary 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: Lower urinary tract symptoms due to benign prostatic hyperplasia Enlarged prostate volume by rectal ultrasound Exclusion Criteria: Previous prostate surgery Previous or current diagnosis of prostate cancer Use of other medications for the treatment of prostatic hyperplasia Urinary tract infection
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Placebo Comparator
Arm Label
botulinum toxin Type A 300 U
botulinum toxin Type A 200 U
botulinum toxin Type A 100 U
Placebo (Normal Saline)
Arm Description
Botulinum toxin Type A 300 U transperineal or transrectal injection on Day 1.
Botulinum toxin Type A 200 U transperineal or transrectal injection on Day 1.
Botulinum toxin Type A 100 U transperineal or transrectal injection on Day 1.
Placebo (Normal Saline) transperineal or transrectal injection on Day 1.
Outcomes
Primary Outcome Measures
Change From Baseline in International Prostate Symptom Score (IPSS) at Week 12
The International Prostate Symptom Score is a disease-specific outcome measure based on the American Urological Association Symptom Index. The questionnaire consists of seven items. The patient evaluates their urinary symptoms (incomplete emptying, frequency, hesitancy, urgency, weak stream, straining, and nocturia) during the previous 4 weeks. The total symptom score can range from 0 (no symptoms) to 35 (most severe symptoms). A negative change from baseline indicates improvement.
Secondary Outcome Measures
Change From Baseline in International Prostate Symptom Score (IPSS) at Week 72
The International Prostate Symptom Score is a disease-specific outcome measure based on the American Urological Association Symptom Index. The questionnaire consists of seven items. The patient evaluates their urinary symptoms (incomplete emptying, frequency, hesitancy, urgency, weak stream, straining, and nocturia) during the previous 4 weeks. The total symptom score can range from 0 (no symptoms) to 35 (most severe symptoms). A negative change from baseline indicates improvement.
Change From Baseline in Peak Urine Flow Rate
Urinary flow was determined by uroflowmetry at baseline and various time-points during the study. An increase from baseline indicates improvement.
Change From Baseline in Total Prostate Volume
Measurement of the prostate volume was performed via transrectal ultrasound at baseline and various time-points during the study. The prostate gland was scanned and the volume was calculated using the formula: Volume (mL) = length × width × height × 0.523. A negative change from baseline indicates improvement.
Change From Baseline in Transitional Zone Prostate Volume
Measurement of the transitional zone prostate volume was performed via transrectal ultrasound at baseline and various time-points during the study. The prostate gland was scanned and the volume was calculated using the formula: Volume (mL) = length × width × height × 0.523. A negative change from baseline indicates improvement.
Change From Baseline in Post-Void Residual
Post-void residual urine volume was assessed by bladder scan or ultrasound on all participants at baseline and various time-points during the study. After voiding, any residual urine volume in the bladder was measured. A negative change from baseline indicates improvement.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00284518
Brief Title
Safety and Efficacy Study of Botulinum Toxin Type A to Treat Lower Urinary Symptoms Due to Benign Prostatic Hyperplasia
Study Type
Interventional
2. Study Status
Record Verification Date
November 2012
Overall Recruitment Status
Completed
Study Start Date
December 2005 (undefined)
Primary Completion Date
May 2009 (Actual)
Study Completion Date
May 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Allergan
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study was to determine the safety and effectiveness of different doses of botulinum toxin Type A in treating lower 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
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
380 (Actual)
8. Arms, Groups, and Interventions
Arm Title
botulinum toxin Type A 300 U
Arm Type
Experimental
Arm Description
Botulinum toxin Type A 300 U transperineal or transrectal injection on Day 1.
Arm Title
botulinum toxin Type A 200 U
Arm Type
Experimental
Arm Description
Botulinum toxin Type A 200 U transperineal or transrectal injection on Day 1.
Arm Title
botulinum toxin Type A 100 U
Arm Type
Experimental
Arm Description
Botulinum toxin Type A 100 U transperineal or transrectal injection on Day 1.
Arm Title
Placebo (Normal Saline)
Arm Type
Placebo Comparator
Arm Description
Placebo (Normal Saline) transperineal or transrectal injection on Day 1.
Intervention Type
Biological
Intervention Name(s)
botulinum toxin Type A
Other Intervention Name(s)
BOTOX®
Intervention Description
Botulinum toxin Type A 300 U, 200 U or 100 U transperineal or transrectal injection on Day 1.
Intervention Type
Drug
Intervention Name(s)
normal saline
Intervention Description
Normal Saline (Placebo) transperineal or transrectal injection on Day 1.
Primary Outcome Measure Information:
Title
Change From Baseline in International Prostate Symptom Score (IPSS) at Week 12
Description
The International Prostate Symptom Score is a disease-specific outcome measure based on the American Urological Association Symptom Index. The questionnaire consists of seven items. The patient evaluates their urinary symptoms (incomplete emptying, frequency, hesitancy, urgency, weak stream, straining, and nocturia) during the previous 4 weeks. The total symptom score can range from 0 (no symptoms) to 35 (most severe symptoms). A negative change from baseline indicates improvement.
Time Frame
Baseline, Week 12
Secondary Outcome Measure Information:
Title
Change From Baseline in International Prostate Symptom Score (IPSS) at Week 72
Description
The International Prostate Symptom Score is a disease-specific outcome measure based on the American Urological Association Symptom Index. The questionnaire consists of seven items. The patient evaluates their urinary symptoms (incomplete emptying, frequency, hesitancy, urgency, weak stream, straining, and nocturia) during the previous 4 weeks. The total symptom score can range from 0 (no symptoms) to 35 (most severe symptoms). A negative change from baseline indicates improvement.
Time Frame
Baseline, Week 72
Title
Change From Baseline in Peak Urine Flow Rate
Description
Urinary flow was determined by uroflowmetry at baseline and various time-points during the study. An increase from baseline indicates improvement.
Time Frame
Baseline, Week 12, Week 72
Title
Change From Baseline in Total Prostate Volume
Description
Measurement of the prostate volume was performed via transrectal ultrasound at baseline and various time-points during the study. The prostate gland was scanned and the volume was calculated using the formula: Volume (mL) = length × width × height × 0.523. A negative change from baseline indicates improvement.
Time Frame
Baseline, Week 12, Week 72
Title
Change From Baseline in Transitional Zone Prostate Volume
Description
Measurement of the transitional zone prostate volume was performed via transrectal ultrasound at baseline and various time-points during the study. The prostate gland was scanned and the volume was calculated using the formula: Volume (mL) = length × width × height × 0.523. A negative change from baseline indicates improvement.
Time Frame
Baseline, Week 12, Week 72
Title
Change From Baseline in Post-Void Residual
Description
Post-void residual urine volume was assessed by bladder scan or ultrasound on all participants at baseline and various time-points during the study. After voiding, any residual urine volume in the bladder was measured. A negative change from baseline indicates improvement.
Time Frame
Baseline, Week 2, Week 12, Week 72
Other Pre-specified Outcome Measures:
Title
Change From Baseline in the International Index of Erectile Function (IIEF) Questionnaire Erectile Function Domain
Description
The IIEF is a 15-item questionnaire filled out by the patient to assess erectile function over the past 4 weeks that contains five domains. The score for the erectile function domain is the sum of scores for Questions 1, 2, 3, 4, 5 and 15 for a total possible score of 1 to 30. A higher score indicates a better outcome. A positive change from baseline indicates improvement.
Time Frame
Baseline, Week 12, Week 72
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Lower urinary tract symptoms due to benign prostatic hyperplasia
Enlarged prostate volume by rectal ultrasound
Exclusion Criteria:
Previous prostate surgery
Previous or current diagnosis of prostate cancer
Use of other medications for the treatment of prostatic hyperplasia
Urinary tract infection
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Director
Organizational Affiliation
Allergan
Official's Role
Study Director
Facility Information:
City
Murdoch
Country
Australia
City
Vienna
Country
Austria
City
Victoria
State/Province
British Columbia
Country
Canada
City
Olomouc
Country
Czech Republic
City
Paris Cedex 13
Country
France
City
Braunschweig
Country
Germany
City
Perugia
Country
Italy
City
Seoul
Country
Korea, Republic of
City
Martin
Country
Slovakia
City
Taipei
Country
Taiwan
City
London
Country
United Kingdom
12. IPD Sharing Statement
Citations:
PubMed Identifier
23098762
Citation
Marberger M, Chartier-Kastler E, Egerdie B, Lee KS, Grosse J, Bugarin D, Zhou J, Patel A, Haag-Molkenteller C. A randomized double-blind placebo-controlled phase 2 dose-ranging study of onabotulinumtoxinA in men with benign prostatic hyperplasia. Eur Urol. 2013 Mar;63(3):496-503. doi: 10.1016/j.eururo.2012.10.005. Epub 2012 Oct 12.
Results Reference
derived
Learn more about this trial
Safety and Efficacy Study of Botulinum Toxin Type A to Treat Lower Urinary Symptoms Due to Benign Prostatic Hyperplasia
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