Comparing oral medication and Botox for treating urgency urinary incontinence
Beta-Agonist Versus OnabotulinumtoxinA Trial for Urgency Urinary Incontinence
This study is testing whether an oral medication or Botox injections work better for women with urgency urinary incontinence to see which treatment helps them feel more satisfied and manage their symptoms.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 432 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Women and Infants Hospital of Rhode Island Academic / other |
| Drugs / interventions | radiation |
| Locations | 5 sites (Birmingham, Alabama and 4 other locations) |
| Trial ID | NCT05806164 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to compare the effectiveness of an oral medication (beta agonist) against onabotulinumtoxinA injections in women suffering from urgency urinary incontinence (UUI). Participants will be randomly assigned to receive one of the two treatments, with outcomes assessed at 3 months and followed for a total of 12 months. The primary outcomes focus on treatment satisfaction and urinary symptom severity, both of which are important to patients. The study also includes a stakeholder engagement plan to guide decision-making for patients and providers.
Who should consider this trial
Good fit: Ideal candidates are women aged 18 and older who experience significant bother from urgency urinary incontinence and have not found relief from previous treatments.
Not a fit: Patients who are currently pregnant or planning to become pregnant will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide women with more effective treatment options for urgency urinary incontinence.
How similar studies have performed: Other studies have shown success with similar treatment comparisons, but this trial aims to provide more patient-centered outcomes.
Eligibility criteria
Show full inclusion / exclusion 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)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)
Where this trial is running
Birmingham, Alabama and 4 other locations
- University of Alabama at Birmingham — Birmingham, Alabama, United States (Recruiting)
- University of California, San Diego — San Diego, California, United States (Recruiting)
- Howard University — Washington D.C., District of Columbia, United States (Recruiting)
- University of New Mexico — Albuquerque, New Mexico, United States (Recruiting)
- Women & Infants Hospital of Rhode Island — Providence, Rhode Island, United States (Recruiting)
Study contacts
- Principal investigator: Vivian Sung, MD, MPH — Women and Infants Hospital of Rhode Island
- Study coordinator: Ann Meers, BS, RN
- Email: ameers@wihri.org
- Phone: 401-274-1100
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.