Beta-Agonist Versus OnabotulinumtoxinA Trial for Urgency Urinary Incontinence

NCT05806164 | Recruiting Phase 4 FDA Drug

• 1 other identifier: 1895985
• Study Type: interventional
• Target: 432
• Locations: 1 country
• Sites: 5

Brief 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. 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.

Conditions

Urgency Urinary Incontinence

Keywords

UUI; Urgency Incontinence; Beta Agonist; onabotulintoxinA; Botox; Community Engagement

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (5)

• Change in Overactive Bladder Questionnaire-Symptom Bother Scale (OAB-q-SS)

  Baseline until 6, 9, 12 months

• Functional Assessment of Chronic Illness Therapy-Treatment Satisfaction-General Questionnaire (FACIT-TS-G) at 3 months

  6, 9, 12 months

• Change in Overactive Bladder Questionnaire-Health Related Quality of Life (OAB-q-HRQL)

  Baseline to 3, 6, 9, 12 months

• Change in Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-IR)

  Baseline to 3, 6, 9, 12 months

• Patient global impression of improvement (PGI-I)

  3, 6, 9, 12 months

Other Outcomes (3)

• PROMIS Cognitive Function-Short Form

  Baseline to 3, 6, 9, 12 months

• Continuation/discontinuation rate

  From enrollment to end of long-term follow up 3-5 years for LTF cohort study n=346

• Cost

  From end of parent trial (12 months) to completion of long-term follow up study (3-5 years) for n=346

Study Arms (2)

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.

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.

Drug: OnabotulinumtoxinA 100 UNT [Botox]

Interventions

Beta3-Agonists, Adrenergic [Mirabegron/Vibegron] DRUG

The beta-agonist oral medication will be prescribed and dose adjusted per usual care.

Beta-3 receptor agonist oral medication

OnabotulinumtoxinA 100 UNT [Botox] DRUG

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.

Also known as: Botox

Intradetrusor onabotulinumtoxinA

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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
• neurogenic bladder
• pelvic floor surgery within the past 3 months
• anticipating pelvic surgery within primary outcome follow up period (3 months)

Sponsors & Collaborators

• Women and Infants Hospital of Rhode Island: lead
• University of New Mexico: collaborator
• University of Alabama at Birmingham: collaborator
• University of California, San Diego: collaborator
• Howard University: collaborator
• Brown University: collaborator
• Patient-Centered Outcomes Research Institute: collaborator

Study Sites (5)

University of Alabama at Birmingham

Birmingham, Alabama, 35233, United States

RECRUITING

University of California, San Diego

San Diego, California, 92093, United States

RECRUITING

Howard University

Washington D.C., District of Columbia, 20059, United States

RECRUITING

University of New Mexico

Albuquerque, New Mexico, 87131, United States

RECRUITING

Women & Infants Hospital of Rhode Island

Providence, Rhode Island, 02905, United States

RECRUITING

MeSH Terms

Interventions

Adrenergic Agents; mirabegron; N-(4-((5-(hydroxy(phenyl)methyl)pyrrolidin-2-yl)methyl)phenyl)-4-oxo-4,6,7,8-tetrahydropyrrolo(1,2-a)pyrimidine-6-carboxamide; Botulinum Toxins, Type A

Intervention Hierarchy (Ancestors)

Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Physiological Effects of Drugs; Botulinum Toxins; Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases; Bacterial Proteins; Proteins; Amino Acids, Peptides, and Proteins; Bacterial Toxins; Toxins, Biological; Biological Factors

Study Officials

• Vivian Sung, MD, MPH

  Women and Infants Hospital of Rhode Island

  PRINCIPAL INVESTIGATOR

• Peter Jeppson, MD

  University of New Mexico

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ann Meers, BS, RN

CONTACT

401-274-1100; ameers@wihri.org

Sara Veera, BS

CONTACT

401-274-1100; sveera@wihri.org

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Due to the nature of the interventions, masking of patients will not be possible; however, outcome assessors will be masked. Masked staff will not be able to see certain forms that may result in unmasking. All PROs will be administered prior to any clinical assessments to minimize bias that may occur due to clinical evaluation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, MPH, Professor of Obstetrics & Gynecology, The Warren Alpert Medical School of Brown University; Director of Research, Division of Urogynecology, Women & Infants Hospital of Rhode Island

Model Details: 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.

Study Record Dates

• First Submitted: November 15, 2022
• First Posted: April 10, 2023
• Study Start: June 6, 2023
• Primary Completion (Estimated): July 15, 2026
• Study Completion (Estimated): August 1, 2030
• Last Updated: September 25, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE
• Time Frame: Once aims of original protocol are completed

Locations

US (5)