Beta-Agonist Versus OnabotulinumtoxinA Trial for Urgency Urinary Incontinence

1895985

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.

2023-06-06

2026-07-15

2027-07-15

Recruiting

Early phase I

432

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)participant does not desire additional treatment for SUI in the upcoming 3 months. 7. Participants after unsuccessful neuromodulation trial can be eligible after a 4-week washout period. Exclusion criteria: 1. clinical contraindication to beta-3 agonist or onabotulinumtoxinA 2. prior therapeutic trial of either study treatment 3. unevaluated hematuria, current or prior bladder malignancy 4. surgically altered detrusor muscle 5. prior pelvic radiation 6. post-void residual \>150 mL in past 3 months 7. neurogenic bladder 8. pelvic floor surgery within the past 3 months 9. anticipating pelvic surgery within primary outcome follow up period (3 months)

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'At 3 months, the effect of treatment with beta agonist oral medication or onabotulinumtoxinA will be evaluated within a classic RCT model. The analysis will determine the effect of treatment on the co-primary outcomes: Treatment satisfaction and urinary symptom severity.', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'SINGLE', 'maskingDescription': 'Due to the nature of the interventions, masking of patients will not be possible; however, outcome assessors will be masked. Masked staff will not be able to see certain forms that may result in unmasking. All PROs will be administered prior to any clinical assessments to minimize bias that may occur due to clinical evaluation.', 'whoMasked': ['OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 432, 'type': 'ESTIMATED'}}

2023-08-03