Urinary IncontinencePhase 4NCT02601287
A Safety and Efficacy Study of Botulinum Toxin Type A (BOTOX®) to Treat Urinary Incontinence Due to Neurogenic Detrusor Overactivity or Overactive Bladder in Korean Patients
A Phase 4 study testing Botulinum Toxin Type A in people with Urinary Incontinence and Overactive Bladder, run by Allergan at 5 sites in South Korea.
Trial summary
This is a safety and efficacy study of BOTOX® (Botulinum Toxin Type A) in the Treatment of Adult Korean Patients with Urinary Incontinence due to Neurogenic Detrusor Overactivity or Overactive Bladder. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Urinary Incontinence, Overactive Bladder
- What is being tested?
- Botulinum Toxin Type A
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 168 participants
- Where
- 5 sitesSouth Korea
- Study dates
- Nov 2015to Jul 2016
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Urinary incontinence as a result of neurogenic overactive bladder due to spinal cord injury or multiple sclerosis
- Symptoms of urge urinary incontinence, urgency, and frequency due to overactive bladder
Who cannot join
- Myasthenia gravis, Eaton-Lambert syndrome, or amyotrophic lateral sclerosis
- Use of botulinum toxin therapy of any serotype in the 3 months prior to screening
- Has acute urinary retention who do not routinely perform clean intermittent self-catheterization (CIC)
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
South Korea5 sites
Pusan National University Hospital
Busan, Korea, 49241
The Catholic University of Korea Bucheion St. Mary Hospital
Gyeonggi-do, Korea, 14647
Seoul National University Hospital
Seoul, Korea, 03080
Asan Medical Center
Seoul, Korea, 05505
Samsung Medical Center
Seoul, Korea, 06351
About this study
This is a safety and efficacy study of BOTOX® (Botulinum Toxin Type A) in the Treatment of Adult Korean Patients with Urinary Incontinence due to Neurogenic Detrusor Overactivity or Overactive Bladder.
- Conditions
- Urinary Incontinence, Overactive Bladder
- Being tested
- Botulinum Toxin Type A
- Medical subject headings
- Urinary Incontinence, Urinary Bladder, Overactive
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®, onabotulinumtoxinA
Botulinum Toxin Type A into detrusor muscle on Day 1
| Study group | Role | What they receive |
|---|---|---|
| BOTOX® 100U | Experimental | Botulinum Toxin Type A 100U into the detrusor muscle on Day 1 in patients with Overactive Bladder Receives: Biological: Botulinum Toxin Type A |
| BOTOX® 200U | Experimental | Botulinum Toxin Type A 200U into the detrusor muscle on Day 1 in patients with Neurogenic Detrusor Overactivity Receives: Biological: Botulinum Toxin Type A |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from the baseline in the International Consultation on Incontinence Questionnaire Short Form (ICIQ-SF) total score
Measured: Baseline, Day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2015 (estimated)
- Study startNov 2015
- Primary completionJul 2016
- Study completionJul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urinary IncontinenceStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 168 participants (actual)
Sponsor and investigators
- Lead sponsor
- Allergan
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Contact, Study director, Allergan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02601287
- Sponsor's protocol ID
- 191622-151
- Status last verified
- Jul 2016
- First submitted
- 6 Nov 2015
- Last updated
- 21 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Safety and Efficacy Study of Botulinum Toxin Type A (BOTOX®) to Treat Urinary Incontinence Due to Neurogenic Detrusor Overactivity or Overactive Bladder in Korean Patients
- ClinicalTrials.gov ID
- NCT02601287
- Acronym / sponsor ID
- 191622-151
- Conditions
- Urinary Incontinence, Overactive Bladder
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 168 participants (actual)
- Lead sponsor
- AllerganIndustry (pharma, biotech, devices)
- Study start
- Nov 2015
- Primary completion
- Jul 2016 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 10 Nov 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a safety and efficacy study of BOTOX® (Botulinum Toxin Type A) in the Treatment of Adult Korean Patients with Urinary Incontinence due to Neurogenic Detrusor Overactivity or Overactive Bladder.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BOTOX® 100U | Experimental | Biological: Botulinum Toxin Type ABotulinum Toxin Type A 100U into the detrusor muscle on Day 1 in patients with Overactive Bladder |
| BOTOX® 200U | Experimental | Biological: Botulinum Toxin Type ABotulinum Toxin Type A 200U into the detrusor muscle on Day 1 in patients with Neurogenic Detrusor Overactivity |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Urinary incontinence as a result of neurogenic overactive bladder due to spinal cord injury or multiple sclerosis
- Symptoms of urge urinary incontinence, urgency, and frequency due to overactive bladder
Key exclusion criteria (3 listed)
- Myasthenia gravis, Eaton-Lambert syndrome, or amyotrophic lateral sclerosis
- Use of botulinum toxin therapy of any serotype in the 3 months prior to screening
- Has acute urinary retention who do not routinely perform clean intermittent self-catheterization (CIC)
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 into detrusor muscle on Day 1 | Biological | BOTOX® 100U, BOTOX® 200U |
Primary outcome
Change from the baseline in the International Consultation on Incontinence Questionnaire Short Form (ICIQ-SF) total score
Time frame: Baseline, Day 28
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2016.
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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 Contact study director
Allergan
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Botulinum Toxin Type A in people with Urinary Incontinence and Overactive Bladder, run by Allergan at 5 sites in South Korea.
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 3 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 21 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in South Korea. 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. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 the baseline in the International Consultation on Incontinence Questionnaire Short Form (ICIQ-SF) total score (time frame: Baseline, Day 28). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Jul 2016.