Urgency Urinary Incontinence Clinical Trial
— BESTOfficial title:
Beta-Agonist Versus OnabotulinumtoxinA Trial for Urgency Urinary Incontinence
NCT number | NCT05806164 |
Other study ID # | 1895985 |
Secondary ID | |
Status | Recruiting |
Phase | Phase 4 |
First received | |
Last updated | |
Start date | June 6, 2023 |
Est. completion date | July 15, 2027 |
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.
Status | Recruiting |
Enrollment | 432 |
Est. completion date | July 15, 2027 |
Est. primary completion date | July 15, 2026 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years and older |
Eligibility | 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) |
Country | Name | City | State |
---|---|---|---|
United States | University of New Mexico | Albuquerque | New Mexico |
United States | University of Alabama at Birmingham | Birmingham | Alabama |
United States | Women & Infants Hospital of Rhode Island | Providence | Rhode Island |
United States | University of California, San Diego | San Diego | California |
United States | Howard University | Washington | District of Columbia |
Lead Sponsor | Collaborator |
---|---|
Women and Infants Hospital of Rhode Island | Brown University, Howard University, Patient-Centered Outcomes Research Institute, University of Alabama at Birmingham, University of California, San Diego, University of New Mexico |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | PROMIS Cognitive Function-Short Form | Generic cognitive function measure (8 items), higher scores indicate better function | Baseline to 3, 6, 9, 12 months | |
Primary | Change in score Overactive Bladder Questionnaire-Symptom Bother Scale (OAB-q-SS) at 3 months | 8-item questionnaire measuring symptom bother of overactive bladder symptoms, higher scores indicate more bothersome symptoms | Baseline until 3 months | |
Primary | Functional Assessment of Chronic Illness Therapy-Treatment Satisfaction-General Questionnaire (FACIT-TS-G) at 3 months | Single item "How do you rate this treatment overall" on a 5-point likert scale | 3 months | |
Secondary | Change in Overactive Bladder Questionnaire-Symptom Bother Scale (OAB-q-SS) | 8-item questionnaire measuring symptom bother of overactive bladder symptoms | Baseline until 6, 9, 12 months | |
Secondary | Functional Assessment of Chronic Illness Therapy-Treatment Satisfaction-General Questionnaire (FACIT-TS-G) at 3 months | 8-item questionnaire assessing treatment satisfaction of adults undergoing treatment for chronic conditions | 6, 9, 12 months | |
Secondary | Change in Overactive Bladder Questionnaire-Health Related Quality of Life (OAB-q-HRQL) | Overactive bladder disease specific questionnaire measuring quality of life, higher scores indicate better HRQL | Baseline to 3, 6, 9, 12 months | |
Secondary | Change in Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-IR) | Validated tool assessing female sexual function in women with pelvic floor disorders; higher scores reflect better sexual functioning | Baseline to 3, 6, 9, 12 months | |
Secondary | Patient global impression of improvement (PGI-I) | Global measure of patient impression of improvement, likert scale | 3, 6, 9, 12 months |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT05557175 -
Repetitive Transcranial Magnetic Stimulation (rTMS) on Neurogenic Overactive Bladder in Stroke
|
N/A | |
Recruiting |
NCT05512039 -
Reduced-dose Botox for Urgency Incontinence Among Elder Females
|
Phase 1/Phase 2 | |
Recruiting |
NCT05604222 -
Effect of Behavioral Sleep Intervention on Lower Urinary Tract Symptoms in Older Women
|
Phase 4 | |
Completed |
NCT01505439 -
A Study to Estimate the Efficacy and Safety of Solifenacin in Female With Stress Urinary Incontinence and Urgency Urinary Incontinence
|
Phase 4 | |
Recruiting |
NCT04731961 -
Reduction in Number of Botox Injections for Urgency Urinary Incontinence
|
N/A | |
Recruiting |
NCT04227184 -
Investigation of Brain Mechanisms Involved in Urgency Urinary Incontinence
|
Phase 4 | |
Completed |
NCT02833402 -
Sacral Neuromodulation and the Microbiome
|
||
Recruiting |
NCT04599088 -
Investigation of Brain Mechanisms Involved in the Urinary Continence Mechanism Associated With Aging
|
N/A | |
Completed |
NCT03029624 -
eCoin Tibial Nerve Stimulation for OAB
|
N/A |