Beta-Agonist Versus OnabotulinumtoxinA Trial for Urgency Urinary Incontinence

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
Women and Infants Hospital of Rhode Island
Study ID
NCT05806164
Phase
PHASE4
Status
Recruiting
Apply to this trial

Conditions

  • Urgency Urinary Incontinence

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • 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
    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 Details

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.

Key Dates

Start date
Jun 6, 2023
Status verified
Sep 2025
Primary completion
Jul 15, 2026
Completion
Aug 1, 2030

Study Design

Enrollment
432 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Beta-3 receptor agonist oral medication
    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.
  • Active Comparator: Intradetrusor onabotulinumtoxinA
    OnabotulinumtoxinA at a dose of 100 units will be injected into the bladder per usual care pathways.

Primary Outcome Measure

Change in score Overactive Bladder Questionnaire-Symptom Bother Scale (OAB-q-SS) at 3 months [ Time Frame: Baseline until 3 months ]

Central Contacts

Locations (5)

FacilityCityStateZIPSite coordinators
University of Alabama at BirminghamBirminghamAlabama35233
Sunita Patel
[email protected]
205-996-0241
Gabriella Halder, MD
Holly Richter, PhD, MD (PRINCIPAL_INVESTIGATOR)
University of California, San DiegoSan DiegoCalifornia92093
Kyle Herrala
[email protected]
858-657-6827
Emily Lukacz, MD (PRINCIPAL_INVESTIGATOR)
Howard UniversityWashington D.C.District of Columbia20059
Angela Silva
[email protected]
Tatiana Sanses, MD (PRINCIPAL_INVESTIGATOR)
University of New MexicoAlbuquerqueNew Mexico87131
Karen Taylor
[email protected]
505-205-4118
Cassandra Darley
[email protected]
Peter Jeppson, MD (PRINCIPAL_INVESTIGATOR)
Women & Infants Hospital of Rhode IslandProvidenceRhode Island02905
Madeline Malloy, BS, RN
[email protected]
401-274-1100
Sara Veera, BS
[email protected]
401-274-1100

Find similar trials in Birmingham, AL

By research site
University of Alabama at Birmingham· Birmingham, ALUniversity of California, San Diego· San Diego, CAHoward University· Washington D.C., DCUniversity of New Mexico· Albuquerque, NMWomen & Infants Hospital of Rhode Island· Providence, RI

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