Benign Prostatic HyperplasiaPhase 2NCT01107392
Safety and Efficacy of Botulinum Toxin Type A to Treat Lower Urinary Tract 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 8 sites in 8 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 45 years and older, men only
- Conditions the study is for
- Benign Prostatic Hyperplasia
- What is being tested?
- botulinum toxin Type A and Normal saline
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 315 participants
- Where
- 8 sitesin 8 countries
- Study dates
- 1 Aug 2010to 8 Jun 2012
- 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 45 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical enlargement of the prostate gland
- Body weight ≥ 50 kg or 110 lbs
Who cannot join
- 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
Trial locations and contacts
8 sites in 8 countries.
8 sites in 8 countries
About this study
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.
- 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.
Also called BOTOX®, onabotulinumtoxinA
botulinum toxin Type A total dose of 200U equally divided and administered to each lateral prostatic lobe.
Normal salineDrug
Placebo (Normal saline) equally divided and administered to each lateral prostatic lobe.
| Study group | Role | What they receive |
|---|---|---|
| botulinum toxin Type A | Experimental | botulinum toxin Type A total dose of 200U equally divided and administered to each lateral prostatic lobe. Receives: Drug: botulinum toxin Type A |
| Placebo (Normal saline) | Placebo comparator | Placebo (Normal saline) equally divided and administered to each lateral prostatic lobe. 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 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.
Measured: Baseline, Week 12
Secondary outcomes (3)
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.
Measured: Baseline, Week 6, Week 24
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.
Measured: Baseline, Weeks 6, 12 and 24
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.
Measured: 24 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2010 (estimated)
- Study start1 Aug 2010
- Primary completion16 Mar 2012
- Study completion8 Jun 2012
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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 315 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
- NCT01107392
- Sponsor's protocol ID
- 191622-100
- Status last verified
- Apr 2019
- First submitted
- 16 Apr 2010
- Last updated
- 3 May 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
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.
PubMed 24508634
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Botulinum Toxin Type A to Treat Lower Urinary Tract Symptoms Due to Benign Prostatic Hyperplasia
- ClinicalTrials.gov ID
- NCT01107392
- Acronym / sponsor ID
- 191622-100
- Conditions
- Benign Prostatic Hyperplasia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 315 participants (actual)
- Lead sponsor
- AllerganIndustry (pharma, biotech, devices)
- Study start
- 1 Aug 2010 (actual)
- Primary completion
- 16 Mar 2012 (actual)
- Study completion
- 8 Jun 2012 (actual)
- First posted
- 21 Apr 2010 (estimated)
- Results
- Posted 4 Apr 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| botulinum toxin Type A | Experimental | Drug: botulinum toxin Type Abotulinum toxin Type A total dose of 200U equally divided and administered to each lateral prostatic lobe. |
| Placebo (Normal saline) | Placebo comparator | Drug: Normal salinePlacebo (Normal saline) equally divided and administered to each lateral prostatic lobe. |
Who may qualify
- Ages
- 45 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Clinical enlargement of the prostate gland
- Body weight ≥ 50 kg or 110 lbs
Key exclusion criteria (7 listed)
- 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
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®, onabotulinumtoxinAbotulinum toxin Type A total dose of 200U equally divided and administered to each lateral prostatic lobe. | Drug | botulinum toxin Type A |
| Normal salinePlacebo (Normal saline) equally divided and administered to each lateral prostatic lobe. | Drug | Placebo (Normal saline) |
Primary outcome
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.
3 secondary outcomes
Change From Baseline in the Total International Prostate Symptom Score (IPSS)
Time frame: Baseline, Week 6, Week 24
Change From Baseline in Peak Urine Flow Rate
Time frame: Baseline, Weeks 6, 12 and 24
Duration of Effect
Time frame: 24 Weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 24508634McVary 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.
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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
8 sites in 8 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 8 sites in 8 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 7 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 3 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United States, Canada, Czechia, France, Germany and 3 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 4 Apr 2014). 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 the Total 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 NCT01107392, 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 3 May 2019.