Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

RECRUITING Phase 4

Beta-Agonist Versus OnabotulinumtoxinA Trial for Urgency Urinary Incontinence

NCT05806164 · View on ClinicalTrials.gov ↗

Study 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.

Interventions

  • DRUG OnabotulinumtoxinA 100 UNT [Botox]
  • DRUG Beta3-Agonists, Adrenergic [Mirabegron/Vibegron]

Study Locations (5)

Alabama

  • University of Alabama at Birmingham — Birmingham

California

  • University of California, San Diego — San Diego

District of Columbia

  • Howard University — Washington D.C.

New Mexico

  • University of New Mexico — Albuquerque

Rhode Island

  • Women & Infants Hospital of Rhode Island — Providence

Trial Details

FieldValue
Enrollment Target 432 participants
Start Date 2023-06-06
Est. Completion 2030-08-01
Phase Phase 4

Interested in This Trial?

Always speak with your doctor before enrolling in a clinical trial.

Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT05806164

The ClinicalTrials.gov registry entry for NCT05806164 describes a study currently listed as recruiting. It is categorized as Phase 4, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 432 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Women and Infants Hospital of Rhode Island, which has 25 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Urgency Urinary Incontinence appearing as the primary indexed condition, and to 2 interventions — of which OnabotulinumtoxinA 100 UNT [Botox] is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT05806164 reports 5 study locations spanning 5 distinct geographic areas — top geographies include Alabama, California, District of Columbia. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT05806164 about?

NCT05806164 is a clinical study titled "Beta-Agonist Versus OnabotulinumtoxinA Trial for Urgency Urinary Incontinence". 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 ...

What is the current status of trial NCT05806164?

This trial is currently recruiting. It is a Phase 4 study. The enrollment target is 432 participants. The study started on 2023-06-06. Estimated completion is 2030-08-01.

What conditions does trial NCT05806164 study?

This clinical trial studies the following conditions: Urgency Urinary Incontinence. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT05806164?

The interventions under investigation include: OnabotulinumtoxinA 100 UNT [Botox] (DRUG), Beta3-Agonists, Adrenergic [Mirabegron/Vibegron] (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT05806164?

This trial is sponsored by Women and Infants Hospital of Rhode Island, which has 25 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT05806164 being conducted?

This trial has 5 study locations across Alabama, California, District of Columbia, New Mexico, Rhode Island. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial