Beta-Agonist Versus OnabotulinumtoxinA Trial for Urgency Urinary Incontinence
Trial Parameters
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.
Eligibility Criteria
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 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)parti