Urinary Bladder, OveractiveNCT02557971
Urinary Retention Rates in Clinical Practice After Treatment With OnabotulinumtoxinA for Idiopathic Overactive Bladder
An observational study of Urinary Bladder, Overactive, run by Allergan at 7 sites in United States.
Trial summary
This study is a retrospective chart review of patients treated with BOTOX® for idiopathic Overactive Bladder (OAB) as standard of care in clinical practice. The study will determine the rate of post procedural urinary retention requiring catheterization and identify factors that may predict urinary retention. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Urinary Bladder, Overactive
- What is being tested?
- onabotulinumtoxinA
- Type of treatment
- Injection or infusion
- How many people
- 315 participants
- Where
- 7 sitesUnited States
- Study dates
- Aug 2015to Jul 2016
- Phase
- Observational
- 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
Study population: Patients prescribed BOTOX® for the treatment of idiopathic OAB in clinical practice.
Who may be able to join
- -Patients treated with BOTOX® for Overactive Bladder.
Who cannot join
- Received botulinum toxin formulations other than BOTOX® in the bladder.
- Had symptoms of OAB associated with a neurological condition.
- Had a history of chronic urinary retention treated with Clean Intermittent Catheterization (CIC) or indwelling catheter.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
The Charlotte-Mecklenburg Hospital Authority DBA Carolinas Healthcare System
Charlotte, North Carolina, 28203
MetroHealth Medical Center
Cleveland, Ohio, 44109
University of California, Davis
Davis, California, 95616
Alliance Urology Specialists, PA
Greensboro, North Carolina, 27403
Capital Region Urology
Irvine, California, 92612
Virginia Women's Center Inc.
Richmond, Virginia, 23233
Forsyth Memorial Hospital Inc. dba Novant Health Urology Partners
Winston-Salem, North Carolina, 27103
About this study
This study is a retrospective chart review of patients treated with BOTOX® for idiopathic Overactive Bladder (OAB) as standard of care in clinical practice. The study will determine the rate of post procedural urinary retention requiring catheterization and identify factors that may predict urinary retention.
- Conditions
- Urinary Bladder, Overactive
- Being tested
- onabotulinumtoxinA
- Medical subject headings
- Urinary Bladder, Overactive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
onabotulinumtoxinADrug
Also called BOTOX®, botulinum toxin Type A
OnabotulinumtoxinA (BOTOX®) as prescribed in clinical practice.
| Study group | Role | What they receive |
|---|---|---|
| BOTOX® | Patients with idiopathic overactive bladder (OAB) treated with onabotulinumtoxinA (BOTOX®) injections into the bladder as standard of care in clinical practice. No intervention was administered in this study. Receives: Drug: onabotulinumtoxinA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants with Post-Procedure Urinary Retention requiring Catheterization
Measured: 12 Weeks
Length of Time of Clean Intermittent Catheterization (CIC) Use
Measured: 12 Weeks
Secondary outcomes (1)
Percentage of Participants with Urinary Tract Infection (UTI)
Measured: 12 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2015 (estimated)
- Study startAug 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 Bladder, OveractiveStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- 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
- NCT02557971
- Sponsor's protocol ID
- GMA-US-OAB-0403
- Status last verified
- Aug 2016
- First submitted
- 22 Sep 2015
- Last updated
- 2 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Urinary Retention Rates in Clinical Practice After Treatment With OnabotulinumtoxinA for Idiopathic Overactive Bladder
- ClinicalTrials.gov ID
- NCT02557971
- Acronym / sponsor ID
- GMA-US-OAB-0403
- Conditions
- Urinary Bladder, Overactive
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 315 participants (actual)
- Lead sponsor
- AllerganIndustry (pharma, biotech, devices)
- Study start
- Aug 2015
- Primary completion
- Jul 2016 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 23 Sep 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 study is a retrospective chart review of patients treated with BOTOX® for idiopathic Overactive Bladder (OAB) as standard of care in clinical practice. The study will determine the rate of post procedural urinary retention requiring catheterization and identify factors that may predict urinary retention.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| BOTOX® | – | Drug: onabotulinumtoxinAPatients with idiopathic overactive bladder (OAB) treated with onabotulinumtoxinA (BOTOX®) injections into the bladder as standard of care in clinical practice. No intervention was administered in this study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients prescribed BOTOX® for the treatment of idiopathic OAB in clinical practice.
Key inclusion criteria (1 listed)
- -Patients treated with BOTOX® for Overactive Bladder.
Key exclusion criteria (3 listed)
- Received botulinum toxin formulations other than BOTOX® in the bladder.
- Had symptoms of OAB associated with a neurological condition.
- Had a history of chronic urinary retention treated with Clean Intermittent Catheterization (CIC) or indwelling catheter.
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 |
|---|---|---|
| onabotulinumtoxinAAlso: BOTOX®, botulinum toxin Type AOnabotulinumtoxinA (BOTOX®) as prescribed in clinical practice. | Drug | BOTOX® |
Primary outcome
Percentage of Participants with Post-Procedure Urinary Retention requiring Catheterization
Time frame: 12 Weeks
Length of Time of Clean Intermittent Catheterization (CIC) Use
Time frame: 12 Weeks
1 secondary outcome
Percentage of Participants with Urinary Tract Infection (UTI)
Time frame: 12 Weeks
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 2 Sep 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 Director study director
Allergan
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Urinary Bladder, Overactive, run by Allergan at 7 sites in United States.
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 1 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 2 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States. 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.
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?
Percentage of Participants with Post-Procedure Urinary Retention requiring Catheterization (time frame: 12 Weeks). The study lists 2 primary outcomes in all. 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 2 Sep 2016.