Mirabegron and Urinary Urgency Incontinence: The Clinical Response and the Female Urinary Microbiome
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 84
- 试验地点
- 1
- 主要终点
- Response to Therapy
研究概览
简要总结
This study is for women diagnosed with urinary urgency incontinence (UUI) or overactive bladder (OAB). Some patients continue to have symptoms even while taking medication for OAB. The purpose of this study is to estimate the number of women who respond to a medication called mirabegron and estimate change in symptom severity over 12 weeks of therapy. A secondary goal is to correlate the female urinary microbiome (FUM) with response to treatment and change in symptom severity over 12 weeks of therapy.
详细描述
Mirabegron is an FDA-approved medication for urgency incontinence. Evaluation of mirabegron's influence on clinical symptoms may need to take into account the effect of the female urinary microbiome (FUM) on a patient's response to treatment. Compared to asymptomatic patients, several bacterial species are more common in patients with overactive bladder.
Currently, physicians have limited ability to personalize a patient's urinary urgency incontinence treatment and, consequently, the prescribed medication may provide minimal symptom relief. Since the FUM can be assessed prior to treatment, this study proposes to determine if baseline FUM assessment can provide insight into future symptom relief with mirabegron treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
盲法说明
There is no masking scheme
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Bothersome idiopathic (non-neurologic) urgency urinary incontinence (UUI) who recall ≥ 5 urgency predominant urinary incontinence episodes in the prior week (urgency urinary incontinence or mixed urinary incontinence-urgency predominant)
- •No contraindications to taking mirabegron
- •Patients on current OAB therapy will undergo a two-week drug washout period prior to baseline assessment
排除标准
- •Neurologic disease known to affect the lower urinary tract
- •Systemic immunologic deficiency
- •Current urinary tract infection (UTI) (based on dipstick assessment) or recurrent culture-proven UTIs
- •History or current pelvic malignancy or radiation
- •Untreated symptomatic pelvic organ prolapse (POP) > POP-Q Stage II
- •A contraindication to receiving mirabegron
- •Women of childbearing potential who are pregnant or nursing or intend to become pregnant during the study, or who are not practicing a reliable method of contraception
- •Must not have taken any antibiotics in the 4 weeks prior to enrollment
研究组 & 干预措施
Mirabegron
Participants received mirabegron (Myrbetriq) daily for 12 weeks
干预措施: Mirabegron (Drug)
结局指标
主要结局
Response to Therapy
时间窗: 12 weeks
Response to therapy was measured using the Patient Perception of Bladder Control (PPBC) questionnaire which measures patients' perceived bladder condition on a 6-point ordinal scale ranging from 1 (no problems at all) to 6 (many severe problems). Women reporting a PPBC score of 4 or 5 by week 12 responded to therapy. Women reporting a PPBC score of 1, 2, or 3 by week 12 did not respond to therapy.
次要结局
- Change in Overactive Bladder Questionnaire (OAB-q) Health Related Quality of Life (HRQL)(12 weeks)
- Change in Urinary Distress Inventory (UDI)(12 weeks)
- Change in Pelvic Organ Prolapse Distress Inventory (POPDI) Score(12 weeks)
- Change in Colo-Rectal-Anal Distress Inventory (CRADI)(12 weeks)
研究者
Alan J. Wolfe
Professor
Loyola University