Urgency Urinary IncontinencePhase 4BESTNCT05806164
Beta-Agonist Versus OnabotulinumtoxinA Trial for Urgency Urinary Incontinence
A Phase 4 study testing Beta3-Agonists, Adrenergic [Mirabegron/Vibegron] and OnabotulinumtoxinA 100 UNT [Botox] in people with Urgency Urinary Incontinence, run by Women and Infants Hospital of Rhode Island at 5 sites in United States.
Trial summary
The goal of this clinical trial is to compare treatment outcomes between an oral medication (beta agonist) versus onabotulinumtoxinA injections in women with urgency urinary incontinence (UUI). Participants will be randomly selected to receive one of the two treatments. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Urgency Urinary Incontinence
- What is being tested?
- Beta3-Agonists, Adrenergic [Mirabegron/Vibegron] and OnabotulinumtoxinA 100 UNT [Botox]
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 432 participants
- Where
- 5 sitesUnited States
- Study dates
- 6 Jun 2023to 1 Aug 2030
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18 years or older
- report at least "quite a bit bothered" or worse by their UUI defined by response to OAB-q-SS item #8 "How bothered are you by urine loss associated with a strong desire to urinate?"
- are not and do not plan to become pregnant
- have persistent UUI defined as previous unsuccessful results after conservative and anticholinergic treatment, or are unable to tolerate or have contraindications to anticholinergics
- are currently not taking anticholinergics or are willing to stop medication for 3 weeks prior to enrollment.
- for participants reporting mixed urinary incontinence symptoms, participant must (a) have less bother from SUI than from UUI, defined as a response of "Not at all bothered" or only "a little bit bothered" by SUI on the Urogenital Distress Inventory item "Do you experience urine leakage related to physical activity? (walking, running, laughing, sneezing, coughing), and (b) SUI symptoms be stable (> 3 months), and (c)participant does not desire additional treatment for SUI in the upcoming 3 months.
- Participants after unsuccessful neuromodulation trial can be eligible after a 4-week washout period.
Who cannot join
- clinical contraindication to beta-3 agonist or onabotulinumtoxinA
- prior therapeutic trial of either study treatment
- unevaluated hematuria, current or prior bladder malignancy
- surgically altered detrusor muscle
- prior pelvic radiation
- post-void residual >150 mL in past 3 months
Show all 9Show fewer
- neurogenic bladder
- pelvic floor surgery within the past 3 months
- anticipating pelvic surgery within primary outcome follow up period (3 months)
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
University of New Mexico
Albuquerque, New Mexico, 87131
University of Alabama at Birmingham
Birmingham, Alabama, 35233
Women & Infants Hospital of Rhode Island
Providence, Rhode Island, 02905
University of California, San Diego
San Diego, California, 92093
Howard University
Washington D.C., District of Columbia, 20059
About this study
The goal of this clinical trial is to compare treatment outcomes between an oral medication (beta agonist) versus onabotulinumtoxinA injections in women with urgency urinary incontinence (UUI).
Participants will be randomly selected to receive one of the two treatments. The primary outcome measure will be at 3 months, and women will be followed for a total of 12 months.
Read more
Based on patient expert input, there are 2 primary outcomes: Treatment satisfaction and urinary symptom severity.
The study will also have a long-term follow-up component (prospective cohort) including 346 participants from the parent trial to describe treatment continuation, treatment efficacy, patient direct costs and other secondary outcomes up to 5 years after treatment.
Read the detailed description
The purpose of this study is to directly compare 2 primary outcomes (Treatment satisfaction and urinary symptom severity) between beta agonist oral medication versus onabotulinumtoxinA intradetrusor bladder injection for the treatment of UUI.
The study will also compare secondary outcomes identified as important by patients. At the end of the study, the investigators will have patient and stakeholder-derived comparative outcomes between these 2 commonly available treatment categories. A stakeholder and community engagement (CE) plan will be developed and implemented. The investigators will also develop a model to help guide patients and providers through this decision process.
SPECIFIC AIMS Specific Aim 1: Compare the efficacy of beta agonist versus onabotulinumtoxinA on patient-important treatment outcomes at 3 months in women with UUI.
This multi-center, randomized clinical trial (RCT) includes 5 sites across the U.S. Two co-primary outcomes will be measured using validated patient-reported outcomes (PROs), selected by patients: Co-primary outcome 1: Symptom severity, measured by change in Overactive Bladder Questionnaire-Symptom Bother Scale (OAB-q-SS) score.
Co-primary outcome 2: Treatment satisfaction, measured by the Functional Assessment of Chronic Illness Therapy-Treatment Satisfaction-General (FACIT-TS-G), powered based on a single item.
Specific Aim 2: Compare secondary patient-important outcomes. Direct comparisons between intervention effects on secondary outcomes chosen by patients and stakeholders, including adverse events, UUI quality of life, global improvement, and sexual function.
Specific Aim 3: Use predictive modeling to help stakeholders better determine expected outcomes after treatment with beta agonist versus onabotulinumtoxinA.
Comparators: Beta agonist oral medication (mirabegron or vibegron) versus intradetrusor onabotulinumtoxinA.
Both beta-agonists and onabotulinumtoxinA are US Food and Drug Administration (FDA) approved for the treatment of UUI, and widely available options with established efficacy.
432 women will be randomly assigned to each treatment option: 216 to beta agonist oral medication and 216 to intradetrusor onabotulintoxinA. Women will be undergo outcomes assessments at 3, 6, 9, and 12 months. The primary outcome measure will be at 3 months.
For the long-term follow up study, a prospective cohort of 346 study participants of the parent trial who agree will be followed with additional outcome assessments for 3-5 years. Outcomes for the long-term follow up study will include: continuation/discontinuation of treatment, treatment satisfaction and symptom control, treatment crossover, additional treatments, patient-important complications, costs, and understanding barriers to continued long-term UUI care and possible solutions. Qualitative methods will be expanded to further explore barriers to continuing long-term UUI care.
- Conditions
- Urgency Urinary Incontinence
- Being tested
- Beta3-Agonists, Adrenergic [Mirabegron/Vibegron], OnabotulinumtoxinA 100 UNT [Botox]
- Keywords
- UUI, Urgency Incontinence, Beta Agonist, onabotulintoxinA, Botox, Community Engagement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Beta3-Agonists, Adrenergic [Mirabegron/Vibegron]Drug
The beta-agonist oral medication will be prescribed and dose adjusted per usual care.
OnabotulinumtoxinA 100 UNT [Botox]Drug
Also called Botox
OnabotulinumtoxinA will be prepared by dissolving 100 units into 10 ml of injectable saline. The injection will be an office based procedure, performed per usual care.
| Study group | Role | What they receive |
|---|---|---|
| Beta-3 receptor agonist oral medication | Active comparator | Selective beta-3 receptor agonist oral medication approved for the treatment of urgency urinary incontinence including mirabegron or vibegron. Usual clinical care standards will be used for prescribing and dosing changes. For mirabegron, dosages are 25 mg and 50 mg as clinically indicated. For vibegron, dosage is 75 mg daily by mouth as clinically indicated. Receives: Drug: Beta3-Agonists, Adrenergic [Mirabegron/Vibegron] |
| Intradetrusor onabotulinumtoxinA | Active comparator | OnabotulinumtoxinA at a dose of 100 units will be injected into the bladder per usual care pathways. Receives: Drug: OnabotulinumtoxinA 100 UNT [Botox] |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in score Overactive Bladder Questionnaire-Symptom Bother Scale (OAB-q-SS) at 3 months
8-item questionnaire measuring symptom bother of overactive bladder symptoms, higher scores indicate more bothersome symptoms
Measured: Baseline until 3 months
Functional Assessment of Chronic Illness Therapy-Treatment Satisfaction-General Questionnaire (FACIT-TS-G) at 3 months
Single item "How do you rate this treatment overall" on a 5-point likert scale
Measured: 3 months
Secondary outcomes (5)
Change in Overactive Bladder Questionnaire-Symptom Bother Scale (OAB-q-SS)
8-item questionnaire measuring symptom bother of overactive bladder symptoms
Measured: Baseline until 6, 9, 12 months
Functional Assessment of Chronic Illness Therapy-Treatment Satisfaction-General Questionnaire (FACIT-TS-G) at 3 months
8-item questionnaire assessing treatment satisfaction of adults undergoing treatment for chronic conditions
Measured: 6, 9, 12 months
Change in Overactive Bladder Questionnaire-Health Related Quality of Life (OAB-q-HRQL)
Overactive bladder disease specific questionnaire measuring quality of life, higher scores indicate better HRQL
Measured: Baseline to 3, 6, 9, 12 months
Change in Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-IR)
Validated tool assessing female sexual function in women with pelvic floor disorders; higher scores reflect better sexual functioning
Measured: Baseline to 3, 6, 9, 12 months
Patient global impression of improvement (PGI-I)
Global measure of patient impression of improvement, likert scale
Measured: 3, 6, 9, 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2023
- Study start6 Jun 2023
- Primary completion30 Aug 2026 (estimated)
- Study completion1 Aug 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urgency 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- At 3 months, the effect of treatment with beta agonist oral medication or onabotulinumtoxinA will be evaluated within a classic RCT model. The analysis will determine the effect of treatment on the co-primary outcomes: Treatment satisfaction and urinary symptom severity.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 432 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Women and Infants Hospital of Rhode Island
- Sponsor type
- University, hospital or other
- Collaborators
- University of New Mexico, University of Alabama at Birmingham, University of California, San Diego, Howard University, Brown University, Patient-Centered Outcomes Research Institute
- Responsible party
- Principal investigator, Vivian Sung, Women and Infants Hospital of Rhode Island
- Investigators
- Vivian Sung, MD, MPH, Principal investigator, Women and Infants Hospital of Rhode IslandPeter Jeppson, MD, Principal investigator, University of New Mexico
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05806164
- Sponsor's protocol ID
- 1895985
- Acronym
- BEST
- Status last verified
- Jun 2026
- First submitted
- 15 Nov 2022
- Last updated
- 29 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: The de-identified database once cleaned will be available to the team, collaborators, and broader scientific community once the primary paper is published per PCORI recommendations.
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Beta-Agonist Versus OnabotulinumtoxinA Trial for Urgency Urinary Incontinence
- ClinicalTrials.gov ID
- NCT05806164
- Acronym / sponsor ID
- BEST / 1895985
- Conditions
- Urgency Urinary Incontinence
- Keywords
- UUI, Urgency Incontinence, Beta Agonist, onabotulintoxinA, Botox, Community Engagement
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 432 participants (estimated)
- Lead sponsor
- Women and Infants Hospital of Rhode IslandUniversity, hospital or other
- Collaborators
- University of New Mexico, University of Alabama at Birmingham, University of California, San Diego, Howard University, Brown University, Patient-Centered Outcomes Research Institute
- Study start
- 6 Jun 2023 (actual)
- Primary completion
- 30 Aug 2026 (estimated)
- Study completion
- 1 Aug 2030 (estimated)
- First posted
- 10 Apr 2023 (actual)
- 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.
The goal of this clinical trial is to compare treatment outcomes between an oral medication (beta agonist) versus onabotulinumtoxinA injections in women with urgency urinary incontinence (UUI).
Participants will be randomly selected to receive one of the two treatments. The primary outcome measure will be at 3 months, and women will be followed for a total of 12 months.
Based on patient expert input, there are 2 primary outcomes: Treatment satisfaction and urinary symptom severity.
The study will also have a long-term follow-up component (prospective cohort) including 346 participants from the parent trial to describe treatment continuation, treatment efficacy, patient direct costs and other secondary outcomes up to 5 years after treatment.
Detailed description
The purpose of this study is to directly compare 2 primary outcomes (Treatment satisfaction and urinary symptom severity) between beta agonist oral medication versus onabotulinumtoxinA intradetrusor bladder injection for the treatment of UUI.
The study will also compare secondary outcomes identified as important by patients. At the end of the study, the investigators will have patient and stakeholder-derived comparative outcomes between these 2 commonly available treatment categories. A stakeholder and community engagement (CE) plan will be developed and implemented. The investigators will also develop a model to help guide patients and providers through this decision process.
SPECIFIC AIMS Specific Aim 1: Compare the efficacy of beta agonist versus onabotulinumtoxinA on patient-important treatment outcomes at 3 months in women with UUI.
This multi-center, randomized clinical trial (RCT) includes 5 sites across the U.S. Two co-primary outcomes will be measured using validated patient-reported outcomes (PROs), selected by patients: Co-primary outcome 1: Symptom severity, measured by change in Overactive Bladder Questionnaire-Symptom Bother Scale (OAB-q-SS) score.
Co-primary outcome 2: Treatment satisfaction, measured by the Functional Assessment of Chronic Illness Therapy-Treatment Satisfaction-General (FACIT-TS-G), powered based on a single item.
Specific Aim 2: Compare secondary patient-important outcomes. Direct comparisons between intervention effects on secondary outcomes chosen by patients and stakeholders, including adverse events, UUI quality of life, global improvement, and sexual function.
Specific Aim 3: Use predictive modeling to help stakeholders better determine expected outcomes after treatment with beta agonist versus onabotulinumtoxinA.
Comparators: Beta agonist oral medication (mirabegron or vibegron) versus intradetrusor onabotulinumtoxinA.
Both beta-agonists and onabotulinumtoxinA are US Food and Drug Administration (FDA) approved for the treatment of UUI, and widely available options with established efficacy.
432 women will be randomly assigned to each treatment option: 216 to beta agonist oral medication and 216 to intradetrusor onabotulintoxinA. Women will be undergo outcomes assessments at 3, 6, 9, and 12 months. The primary outcome measure will be at 3 months.
For the long-term follow up study, a prospective cohort of 346 study participants of the parent trial who agree will be followed with additional outcome assessments for 3-5 years. Outcomes for the long-term follow up study will include: continuation/discontinuation of treatment, treatment satisfaction and symptom control, treatment crossover, additional treatments, patient-important complications, costs, and understanding barriers to continued long-term UUI care and possible solutions. Qualitative methods will be expanded to further explore barriers to continuing long-term UUI care.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- At 3 months, the effect of treatment with beta agonist oral medication or onabotulinumtoxinA will be evaluated within a classic RCT model. The analysis will determine the effect of treatment on the co-primary outcomes: Treatment satisfaction and urinary symptom severity.
| Arm | Type | Receives |
|---|---|---|
| Beta-3 receptor agonist oral medication | Active comparator | Drug: Beta3-Agonists, Adrenergic [Mirabegron/Vibegron]Selective beta-3 receptor agonist oral medication approved for the treatment of urgency urinary incontinence including mirabegron or vibegron. Usual clinical care standards will be used for prescribing and dosing changes. For mirabegron, dosages are 25 mg and 50 mg as clinically indicated. For vibegron, dosage is 75 mg daily by mouth as clinically indicated. |
| Intradetrusor onabotulinumtoxinA | Active comparator | Drug: OnabotulinumtoxinA 100 UNT [Botox]OnabotulinumtoxinA at a dose of 100 units will be injected into the bladder per usual care pathways. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 18 years or older
- report at least "quite a bit bothered" or worse by their UUI defined by response to OAB-q-SS item #8 "How bothered are you by urine loss associated with a strong desire to urinate?"
- are not and do not plan to become pregnant
- have persistent UUI defined as previous unsuccessful results after conservative and anticholinergic treatment, or are unable to tolerate or have contraindications to anticholinergics
- are currently not taking anticholinergics or are willing to stop medication for 3 weeks prior to enrollment.
Key exclusion criteria (9 listed)
- clinical contraindication to beta-3 agonist or onabotulinumtoxinA
- prior therapeutic trial of either study treatment
- unevaluated hematuria, current or prior bladder malignancy
- surgically altered detrusor muscle
- prior pelvic radiation
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 |
|---|---|---|
| Beta3-Agonists, Adrenergic [Mirabegron/Vibegron]The beta-agonist oral medication will be prescribed and dose adjusted per usual care. | Drug | Beta-3 receptor agonist oral medication |
| OnabotulinumtoxinA 100 UNT [Botox]Also: BotoxOnabotulinumtoxinA will be prepared by dissolving 100 units into 10 ml of injectable saline. The injection will be an office based procedure, performed per usual care. | Drug | Intradetrusor onabotulinumtoxinA |
Primary outcome
Change in score Overactive Bladder Questionnaire-Symptom Bother Scale (OAB-q-SS) at 3 months
Time frame: Baseline until 3 months
8-item questionnaire measuring symptom bother of overactive bladder symptoms, higher scores indicate more bothersome symptoms
Functional Assessment of Chronic Illness Therapy-Treatment Satisfaction-General Questionnaire (FACIT-TS-G) at 3 months
Time frame: 3 months
Single item "How do you rate this treatment overall" on a 5-point likert scale
5 secondary outcomes
Change in Overactive Bladder Questionnaire-Symptom Bother Scale (OAB-q-SS)
Time frame: Baseline until 6, 9, 12 months
Functional Assessment of Chronic Illness Therapy-Treatment Satisfaction-General Questionnaire (FACIT-TS-G) at 3 months
Time frame: 6, 9, 12 months
Change in Overactive Bladder Questionnaire-Health Related Quality of Life (OAB-q-HRQL)
Time frame: Baseline to 3, 6, 9, 12 months
Change in Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-IR)
Time frame: Baseline to 3, 6, 9, 12 months
Patient global impression of improvement (PGI-I)
Time frame: 3, 6, 9, 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2026.
- Individual participant dataSharing planned: Yes. The de-identified database once cleaned will be available to the team, collaborators, and broader scientific community once the primary paper is published per PCORI recommendations.
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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.
Vivian Sung, MD, MPH principal investigator
Women and Infants Hospital of Rhode Island
Peter Jeppson, MD principal investigator
University of New Mexico
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 Beta3-Agonists, Adrenergic [Mirabegron/Vibegron] and OnabotulinumtoxinA 100 UNT [Botox] in people with Urgency Urinary Incontinence, run by Women and Infants Hospital of Rhode Island at 5 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 7 inclusion and 9 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: under way, not looking for participants, as of the sponsor's last update on 29 Jun 2026. 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 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.
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?
This study is still under way. Results are not available in the source record yet.
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 in score Overactive Bladder Questionnaire-Symptom Bother Scale (OAB-q-SS) at 3 months (time frame: Baseline until 3 months). 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 29 Jun 2026.