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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT00284518
Registration number
NCT00284518
Ethics application status
Date submitted
31/01/2006
Date registered
1/02/2006
Date last updated
17/12/2012
Titles & IDs
Public title
Safety and Efficacy Study of Botulinum Toxin Type A to Treat Lower Urinary Symptoms Due to Benign Prostatic Hyperplasia
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Scientific title
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Secondary ID [1]
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191622-517
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Benign Prostatic Hyperplasia
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Condition category
Condition code
Renal and Urogenital
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Other renal and urogenital disorders
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Other - botulinum toxin Type A
Treatment: Drugs - normal saline
Experimental: botulinum toxin Type A 300 U - Botulinum toxin Type A 300 U transperineal or transrectal injection on Day 1.
Experimental: botulinum toxin Type A 200 U - Botulinum toxin Type A 200 U transperineal or transrectal injection on Day 1.
Experimental: botulinum toxin Type A 100 U - Botulinum toxin Type A 100 U transperineal or transrectal injection on Day 1.
Placebo comparator: Placebo (Normal Saline) - Placebo (Normal Saline) transperineal or transrectal injection on Day 1.
Treatment: Other: botulinum toxin Type A
Botulinum toxin Type A 300 U, 200 U or 100 U transperineal or transrectal injection on Day 1.
Treatment: Drugs: normal saline
Normal Saline (Placebo) transperineal or transrectal injection on Day 1.
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Intervention code [1]
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Treatment: Other
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Intervention code [2]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Change From Baseline in International Prostate Symptom Score (IPSS) at Week 12
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Assessment method [1]
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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.
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Timepoint [1]
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Baseline, Week 12
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Secondary outcome [1]
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Change From Baseline in International Prostate Symptom Score (IPSS) at Week 72
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Assessment method [1]
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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.
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Timepoint [1]
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Baseline, Week 72
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Secondary outcome [2]
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Change From Baseline in Peak Urine Flow Rate
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Assessment method [2]
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Urinary flow was determined by uroflowmetry at baseline and various time-points during the study. An increase from baseline indicates improvement.
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Timepoint [2]
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Baseline, Week 12, Week 72
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Secondary outcome [3]
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Change From Baseline in Total Prostate Volume
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Assessment method [3]
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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.
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Timepoint [3]
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Baseline, Week 12, Week 72
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Secondary outcome [4]
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Change From Baseline in Transitional Zone Prostate Volume
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Assessment method [4]
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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.
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Timepoint [4]
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Baseline, Week 12, Week 72
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Secondary outcome [5]
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Change From Baseline in Post-Void Residual
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Assessment method [5]
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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.
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Timepoint [5]
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Baseline, Week 2, Week 12, Week 72
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Eligibility
Key inclusion criteria
* Lower urinary tract symptoms due to benign prostatic hyperplasia
* Enlarged prostate volume by rectal ultrasound
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Minimum age
50
Years
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Maximum age
No limit
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Sex
Males
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Can healthy volunteers participate?
No
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Key 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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/12/2005
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/05/2010
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Sample size
Target
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Accrual to date
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Final
380
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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- Murdoch
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Recruitment postcode(s) [1]
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- Murdoch
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Recruitment outside Australia
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Austria
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State/province [1]
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Vienna
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Canada
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State/province [2]
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British Columbia
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Country [3]
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Czech Republic
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State/province [3]
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Olomouc
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Country [4]
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France
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State/province [4]
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Paris Cedex 13
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Country [5]
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Germany
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State/province [5]
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Braunschweig
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Country [6]
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Italy
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State/province [6]
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Perugia
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Country [7]
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Korea, Republic of
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State/province [7]
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Seoul
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Country [8]
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Slovakia
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State/province [8]
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Martin
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Country [9]
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Taiwan
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State/province [9]
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Taipei
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Country [10]
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United Kingdom
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State/province [10]
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London
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Allergan
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Address
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Country
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Ethics approval
Ethics application status
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Summary
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.
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Trial website
https://clinicaltrials.gov/study/NCT00284518
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Trial related presentations / publications
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.
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Public notes
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Contacts
Principal investigator
Name
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Medical Director
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Address
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Allergan
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results are available at
https://clinicaltrials.gov/study/NCT00284518
Download to PDF