๐Ÿ›๏ธ Verified NIH Record โ€ข Updated 2026-06-24

Beta-Agonist Versus OnabotulinumtoxinA Trial for Urgency Urinary Incontinence (NCT05806164)

๐Ÿ”ต Active, Not Recruiting Phase4 ๐Ÿ’Š Investigational Drug / Biologic Sponsor: Women and Infants Hospital of Rhode Island

๐Ÿฉบ Plain-English Summary (8th-Grade Level)

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.

Who can join: Review the eligibility criteria below.

Location: University of Alabama at Birmingham โ€” Birmingham, Alabama

Age range: 18 Years

๐Ÿ“‹ "Do I Qualify?" โ€” 1-Minute Self Screener

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Full eligibility criteria are available on the official NIH protocol. View the criteria โ†—

๐Ÿ“ All Participating Trial Locations (5 Sites)

  • University of Alabama at Birmingham โ€” Birmingham, Alabama
  • University of California, San Diego โ€” San Diego, California
  • Howard University โ€” Washington D.C., District of Columbia
  • University of New Mexico โ€” Albuquerque, New Mexico
  • Women & Infants Hospital of Rhode Island โ€” Providence, Rhode Island

๐Ÿ’ฐ Cost, Insurance & Patient Rights

  • 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
  • Routine Patient Care: Under federal law (ACA ยง 2709) and many state statutes, routine care costs are covered during participation.
  • Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

๐Ÿ’ก How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Review the official NIH record below to find the coordinating site.
  3. Ask about the visit schedule, what is covered at no cost, and any travel support.
  4. Confirm with your own doctor before making a decision.
๐Ÿ›๏ธ View Official NIH Record โ†—