Benign Prostatic HyperplasiaPhase 2NCT00284518
Safety and Efficacy Study of Botulinum Toxin Type A to Treat Lower Urinary Symptoms Due to Benign Prostatic Hyperplasia
A Phase 2 study testing botulinum toxin Type A and normal saline in people with Benign Prostatic Hyperplasia, run by Allergan at 11 sites in 11 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 years and older, men only
- Conditions the study is for
- Benign Prostatic Hyperplasia
- What is being tested?
- botulinum toxin Type A and normal saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 380 participants
- Where
- 11 sitesin 11 countries
- Study dates
- Dec 2005to May 2010
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Lower urinary tract symptoms due to benign prostatic hyperplasia
- Enlarged prostate volume by rectal ultrasound
Who cannot join
- Previous prostate surgery
- Previous or current diagnosis of prostate cancer
- Use of other medications for the treatment of prostatic hyperplasia
- Urinary tract infection
Trial locations and contacts
11 sites in 11 countries.
11 sites in 11 countries
About this study
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.
- Conditions
- Benign Prostatic Hyperplasia
- Being tested
- botulinum toxin Type A, normal saline
- Medical subject headings
- Prostatic Hyperplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
botulinum toxin Type ABiological
Also called BOTOX®
Botulinum toxin Type A 300 U, 200 U or 100 U transperineal or transrectal injection on Day 1.
normal salineDrug
Normal Saline (Placebo) transperineal or transrectal injection on Day 1.
| Study group | Role | What they receive |
|---|---|---|
| botulinum toxin Type A 300 U | Experimental | Botulinum toxin Type A 300 U transperineal or transrectal injection on Day 1. Receives: Biological: botulinum toxin Type A |
| botulinum toxin Type A 200 U | Experimental | Botulinum toxin Type A 200 U transperineal or transrectal injection on Day 1. Receives: Biological: botulinum toxin Type A |
| botulinum toxin Type A 100 U | Experimental | Botulinum toxin Type A 100 U transperineal or transrectal injection on Day 1. Receives: Biological: botulinum toxin Type A |
| Placebo (Normal Saline) | Placebo comparator | Placebo (Normal Saline) transperineal or transrectal injection on Day 1. Receives: Drug: normal saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, Week 12
Secondary outcomes (5)
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.
Measured: Baseline, Week 72
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.
Measured: Baseline, Week 12, Week 72
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.
Measured: Baseline, Week 12, Week 72
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.
Measured: Baseline, Week 12, Week 72
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.
Measured: Baseline, Week 2, Week 12, Week 72
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2006 (estimated)
- Study startDec 2005
- Primary completionMay 2009
- Study completionMay 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Benign Prostatic HyperplasiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 380 participants (actual)
Sponsor and investigators
- Lead sponsor
- Allergan
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Allergan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00284518
- Sponsor's protocol ID
- 191622-517
- Status last verified
- Nov 2012
- First submitted
- 31 Jan 2006
- Last updated
- 17 Dec 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
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.
PubMed 23098762
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy Study of Botulinum Toxin Type A to Treat Lower Urinary Symptoms Due to Benign Prostatic Hyperplasia
- ClinicalTrials.gov ID
- NCT00284518
- Acronym / sponsor ID
- 191622-517
- Conditions
- Benign Prostatic Hyperplasia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 380 participants (actual)
- Lead sponsor
- AllerganIndustry (pharma, biotech, devices)
- Study start
- Dec 2005
- Primary completion
- May 2009 (actual)
- Study completion
- May 2010 (actual)
- First posted
- 1 Feb 2006 (estimated)
- Results
- Posted 17 Dec 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| botulinum toxin Type A 300 U | Experimental | Biological: botulinum toxin Type ABotulinum toxin Type A 300 U transperineal or transrectal injection on Day 1. |
| botulinum toxin Type A 200 U | Experimental | Biological: botulinum toxin Type ABotulinum toxin Type A 200 U transperineal or transrectal injection on Day 1. |
| botulinum toxin Type A 100 U | Experimental | Biological: botulinum toxin Type ABotulinum toxin Type A 100 U transperineal or transrectal injection on Day 1. |
| Placebo (Normal Saline) | Placebo comparator | Drug: normal salinePlacebo (Normal Saline) transperineal or transrectal injection on Day 1. |
Who may qualify
- Ages
- 50 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Lower urinary tract symptoms due to benign prostatic hyperplasia
- Enlarged prostate volume by rectal ultrasound
Key exclusion criteria (4 listed)
- Previous prostate surgery
- Previous or current diagnosis of prostate cancer
- Use of other medications for the treatment of prostatic hyperplasia
- Urinary tract infection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| botulinum toxin Type AAlso: BOTOX®Botulinum toxin Type A 300 U, 200 U or 100 U transperineal or transrectal injection on Day 1. | Biological | botulinum toxin Type A 100 U, botulinum toxin Type A 200 U, botulinum toxin Type A 300 U |
| normal salineNormal Saline (Placebo) transperineal or transrectal injection on Day 1. | Drug | Placebo (Normal Saline) |
Primary outcome
Change From Baseline in International Prostate Symptom Score (IPSS) at Week 12
Time frame: Baseline, 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.
5 secondary outcomes
Change From Baseline in International Prostate Symptom Score (IPSS) at Week 72
Time frame: Baseline, Week 72
Change From Baseline in Peak Urine Flow Rate
Time frame: Baseline, Week 12, Week 72
Change From Baseline in Total Prostate Volume
Time frame: Baseline, Week 12, Week 72
Change From Baseline in Transitional Zone Prostate Volume
Time frame: Baseline, Week 12, Week 72
Change From Baseline in Post-Void Residual
Time frame: Baseline, Week 2, Week 12, Week 72
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 23098762Marberger 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medical Director study director
Allergan
11 sites in 11 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing botulinum toxin Type A and normal saline in people with Benign Prostatic Hyperplasia, run by Allergan at 11 sites in 11 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Dec 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in Australia, Austria, Canada, Czechia, France and 6 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 17 Dec 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline in International Prostate Symptom Score (IPSS) at Week 12 (time frame: Baseline, Week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00284518, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Dec 2012.