Beta-Agonist Versus OnabotulinumtoxinA Trial for Urgency Urinary Incontinence
试验速览
- 阶段
- 4 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 432
- 试验地点
- 7
- 主要终点
- Functional Assessment of Chronic Illness Therapy-Treatment Satisfaction-General Questionnaire (FACIT-TS-G) at 3 months
研究概览
简要总结
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.
详细描述
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 also develop a model to help guide patients and providers through this decision process.
SPECIFIC AIMS Specific Aim 1: Compare the efficacy of beta agonist versus onabotulinumtoxinA on patient-important treatment outcomes at 3 months in women with UUI.
This multi-center, randomized clinical trial (RCT) includes 5 sites across the U.S. Two co-primary outcomes will be measured using validated patient-reported outcomes (PROs), selected by patients: Co-primary outcome 1: Symptom severity, measured by change in Overactive Bladder Questionnaire-Symptom Bother Scale (OAB-q-SS) score.
Co-primary outcome 2: Treatment satisfaction, measured by the Functional Assessment of Chronic Illness Therapy-Treatment Satisfaction-General (FACIT-TS-G), powered based on a single item.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •18 years or older
- •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?"
- •are not and do not plan to become pregnant
- •have persistent UUI defined as previous unsuccessful results after conservative and anticholinergic treatment, or are unable to tolerate or have contraindications to anticholinergics
- •are currently not taking anticholinergics or are willing to stop medication for 3 weeks prior to enrollment.
- •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.
- •Participants after unsuccessful neuromodulation trial can be eligible after a 4-week washout period.
排除标准
- •clinical contraindication to beta-3 agonist or onabotulinumtoxinA
- •prior therapeutic trial of either study treatment
- •unevaluated hematuria, current or prior bladder malignancy
- •surgically altered detrusor muscle
- •prior pelvic radiation
- •post-void residual >150 mL in past 3 months
- •neurogenic bladder
- •pelvic floor surgery within the past 3 months
- •anticipating pelvic surgery within primary outcome follow up period (3 months)
研究组 & 干预措施
Beta-3 receptor agonist oral medication
Selective beta-3 receptor agonist oral medication approved for the treatment of urgency urinary incontinence including mirabegron or vibegron. Usual clinical care standards will be used for prescribing and dosing changes. For mirabegron, dosages are 25 mg and 50 mg as clinically indicated. For vibegron, dosage is 75 mg daily by mouth as clinically indicated.
干预措施: Beta3-Agonists, Adrenergic [Mirabegron/Vibegron] (Drug)
Intradetrusor onabotulinumtoxinA
OnabotulinumtoxinA at a dose of 100 units will be injected into the bladder per usual care pathways.
干预措施: OnabotulinumtoxinA 100 UNT [Botox] (Drug)
结局指标
主要结局
Functional Assessment of Chronic Illness Therapy-Treatment Satisfaction-General Questionnaire (FACIT-TS-G) at 3 months
时间窗: 3 months
Single item "How do you rate this treatment overall" on a 5-point likert scale
Change in score Overactive Bladder Questionnaire-Symptom Bother Scale (OAB-q-SS) at 3 months
时间窗: Baseline until 3 months
8-item questionnaire measuring symptom bother of overactive bladder symptoms, higher scores indicate more bothersome symptoms
次要结局
- Change in Overactive Bladder Questionnaire-Symptom Bother Scale (OAB-q-SS)(Baseline until 6, 9, 12 months)
- Functional Assessment of Chronic Illness Therapy-Treatment Satisfaction-General Questionnaire (FACIT-TS-G) at 3 months(6, 9, 12 months)
- Change in Overactive Bladder Questionnaire-Health Related Quality of Life (OAB-q-HRQL)(Baseline to 3, 6, 9, 12 months)
- Change in Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-IR)(Baseline to 3, 6, 9, 12 months)
- Patient global impression of improvement (PGI-I)(3, 6, 9, 12 months)
研究者
Vivian Sung
MD, MPH, Professor of Obstetrics & Gynecology, The Warren Alpert Medical School of Brown University; Director of Research, Division of Urogynecology, Women & Infants Hospital of Rhode Island
Women and Infants Hospital of Rhode Island