Urinary Bladder, OveractiveNCT03043287
Voiding Efficiency, a Predictor of Clean Intermittent Catheterization (CIC)
An observational study of Urinary Bladder, Overactive, run by Allergan at 3 sites in United States.
Trial summary
This study is a retrospective chart review of patients treated with onabotulinumtoxinA (BOTOX®) for idiopathic overactive bladder (OAB) and will determine voiding efficiency (VE) cutoff ratios that predict post-procedure urinary retention requiring catheterization. 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
- How many people
- 420 participants
- Where
- 3 sitesUnited States
- Study dates
- 12 May 2017to 30 Sep 2019
- 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 treated with BOTOX® for Idiopathic OAB in clinical practice.
Who may be able to join
- Patient with documented idiopathic OAB diagnosis
- Patient was treated with 100-200U of BOTOX® for OAB
- Urodynamics assessment within prior to first BOTOX® injection.
Who cannot join
- Patient had received botulinum toxin formulations other than BOTOX® in the bladder
- Patient had symptoms of OAB associated with a neurological condition (eg, spinal cord injury, multiple sclerosis, cerebrovascular accident, Alzheimer's disease, Parkinson's disease, etc).
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Chesapeake Urology Associates, LLC
Baltimore, Maryland, 21208
Virginia Urology
Richmond, Virginia, 23235
Regional Urology
Shreveport, Louisiana, 71106
About this study
Official title: Voiding Efficiency, a Predictor of CIC
This study is a retrospective chart review of patients treated with onabotulinumtoxinA (BOTOX®) for idiopathic overactive bladder (OAB) and will determine voiding efficiency (VE) cutoff ratios that predict post-procedure urinary retention requiring catheterization.
- 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.
onabotulinumtoxinABiological
Also called Botulinum Toxin Type A, BOTOX®
onabotulinumtoxinA (BOTOX®)100 to 200 U
| Study group | Role | What they receive |
|---|---|---|
| BOTOX® | Participants who received 100 to 200 units (U) onabotulinumtoxinA (BOTOX®) as treatment for OAB. No study drug is administered in this study. Receives: Biological: onabotulinumtoxinA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pre-BOTOX® Injection VE Cutoff-Ratios that Predict the Risk of CIC following Treatment with 100-200U of BOTOX®
VE was calculated as the ratio of voided volume to the total bladder capacity.
Measured: Pre-BOTOX® Injection (Baseline)
Length of Time of CIC Use in Clinical Practice after Treatment with 100-200U BOTOX®
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 posted6 Feb 2017 (estimated)
- Study start12 May 2017
- Primary completion9 Sep 2019
- Study completion30 Sep 2019
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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 420 participants (actual)
Sponsor and investigators
- Lead sponsor
- Allergan
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Dana Fetterolf, Study director, Allergan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03043287
- Sponsor's protocol ID
- CMO-US-URO-0506
- Status last verified
- Feb 2020
- First submitted
- 2 Feb 2017
- Last updated
- 5 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Voiding Efficiency, a Predictor of CIC
- ClinicalTrials.gov ID
- NCT03043287
- Acronym / sponsor ID
- CMO-US-URO-0506
- Conditions
- Urinary Bladder, Overactive
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 420 participants (actual)
- Lead sponsor
- AllerganIndustry (pharma, biotech, devices)
- Study start
- 12 May 2017 (actual)
- Primary completion
- 9 Sep 2019 (actual)
- Study completion
- 30 Sep 2019 (actual)
- First posted
- 6 Feb 2017 (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 onabotulinumtoxinA (BOTOX®) for idiopathic overactive bladder (OAB) and will determine voiding efficiency (VE) cutoff ratios that predict post-procedure urinary retention requiring catheterization.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| BOTOX® | – | Biological: onabotulinumtoxinAParticipants who received 100 to 200 units (U) onabotulinumtoxinA (BOTOX®) as treatment for OAB. No study drug is 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 treated with BOTOX® for Idiopathic OAB in clinical practice.
Key inclusion criteria (3 listed)
- Patient with documented idiopathic OAB diagnosis
- Patient was treated with 100-200U of BOTOX® for OAB
- Urodynamics assessment within prior to first BOTOX® injection.
Key exclusion criteria (2 listed)
- Patient had received botulinum toxin formulations other than BOTOX® in the bladder
- Patient had symptoms of OAB associated with a neurological condition (eg, spinal cord injury, multiple sclerosis, cerebrovascular accident, Alzheimer's disease, Parkinson's disease, etc).
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: Botulinum Toxin Type A, BOTOX®onabotulinumtoxinA (BOTOX®)100 to 200 U | Biological | BOTOX® |
Primary outcome
Pre-BOTOX® Injection VE Cutoff-Ratios that Predict the Risk of CIC following Treatment with 100-200U of BOTOX®
Time frame: Pre-BOTOX® Injection (Baseline)
VE was calculated as the ratio of voided volume to the total bladder capacity.
Length of Time of CIC Use in Clinical Practice after Treatment with 100-200U BOTOX®
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 5 Feb 2020.
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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.
Dana Fetterolf study director
Allergan
3 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 3 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 3 inclusion and 2 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 5 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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?
Pre-BOTOX® Injection VE Cutoff-Ratios that Predict the Risk of CIC following Treatment with 100-200U of BOTOX® (time frame: Pre-BOTOX® Injection (Baseline)). 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 5 Feb 2020; AzTrials last refreshed its copy on 30 Oct 2026.