Beta-Agonist Versus OnabotulinumtoxinA Trial for Urgency Urinary Incontinence

Urgency Urinary Incontinence Clinical Trial

— BEST  

Official title:

Beta-Agonist Versus OnabotulinumtoxinA Trial for Urgency Urinary Incontinence

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05806164
• Other study ID #: 1895985
• Status: Recruiting
• Phase: Phase 4
• Start date: June 6, 2023
• Est. completion date: July 15, 2027

Study information

• Verified date: August 2023
• Source: Women and Infants Hospital of Rhode Island
• Contact: Ann Meers, BS, RN
• Phone: 401-274-1100
• Email: ameers[@]wihri.org
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 432
• Est. completion date: July 15, 2027
• Est. primary completion date: July 15, 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion criteria*:

1. 18 years or older

2. 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?"

3. are not and do not plan to become pregnant

4. have persistent UUI defined as previous unsuccessful results after conservative and anticholinergic treatment, or are unable to tolerate or have contraindications to anticholinergics

5. are currently not taking anticholinergics or are willing to stop medication for 3 weeks prior to enrollment.

6. 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.

7. Participants after unsuccessful neuromodulation trial can be eligible after a 4-week washout period.

Exclusion criteria:

1. clinical contraindication to beta-3 agonist or onabotulinumtoxinA

2. prior therapeutic trial of either study treatment

3. unevaluated hematuria, current or prior bladder malignancy

4. surgically altered detrusor muscle

5. prior pelvic radiation

6. post-void residual >150 mL in past 3 months

7. neurogenic bladder

8. pelvic floor surgery within the past 3 months

9. anticipating pelvic surgery within primary outcome follow up period (3 months)

Related Conditions & MeSH terms

• Enuresis
• Urgency Urinary Incontinence
• Urinary Incontinence

Intervention

Drug:
• Beta3-Agonists, Adrenergic [Mirabegron/Vibegron]
The beta-agonist oral medication will be prescribed and dose adjusted per usual care.
• OnabotulinumtoxinA 100 UNT [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.

Locations

Country	Name	City	State
United States	University of New Mexico	Albuquerque	New Mexico
United States	University of Alabama at Birmingham	Birmingham	Alabama
United States	Women & Infants Hospital of Rhode Island	Providence	Rhode Island
United States	University of California, San Diego	San Diego	California
United States	Howard University	Washington	District of Columbia

Sponsors (7)

Lead Sponsor	Collaborator
Women and Infants Hospital of Rhode Island	Brown University, Howard University, Patient-Centered Outcomes Research Institute, University of Alabama at Birmingham, University of California, San Diego, University of New Mexico

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	PROMIS Cognitive Function-Short Form	Generic cognitive function measure (8 items), higher scores indicate better function	Baseline to 3, 6, 9, 12 months
Primary	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	Baseline until 3 months
Primary	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	3 months
Secondary	Change in Overactive Bladder Questionnaire-Symptom Bother Scale (OAB-q-SS)	8-item questionnaire measuring symptom bother of overactive bladder symptoms	Baseline until 6, 9, 12 months
Secondary	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	6, 9, 12 months
Secondary	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	Baseline to 3, 6, 9, 12 months
Secondary	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	Baseline to 3, 6, 9, 12 months
Secondary	Patient global impression of improvement (PGI-I)	Global measure of patient impression of improvement, likert scale	3, 6, 9, 12 months