Beta-Agonist Versus OnabotulinumtoxinA Trial for Urgency Urinary Incontinence
Women and Infants Hospital of Rhode Island
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.
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 al…
Eligibility
- Age range
- 18+ years
- Sex
- Female
- Healthy volunteers
- Yes
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 reporti…
Interventions
- DrugBeta3-Agonists, Adrenergic [Mirabegron/Vibegron]
The beta-agonist oral medication will be prescribed and dose adjusted per usual care.
- DrugOnabotulinumtoxinA 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 (5)
- University of Alabama at BirminghamBirmingham, Alabama
- University of California, San DiegoSan Diego, California
- Howard UniversityWashington D.C., District of Columbia
- University of New MexicoAlbuquerque, New Mexico
- Women & Infants Hospital of Rhode IslandProvidence, Rhode Island