Vaginal Estradiol vs Oral Beta-3 Agonist for Treatment of Overactive Bladder Syndrome: A Single-Therapy, Double-Blind, Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 152
- 试验地点
- 1
- 主要终点
- OAB-q short form (SF) symptom bother scores
研究概览
简要总结
A single site, double-blinded, randomized controlled trial for postmenopausal women with urinary frequency, urgency, nocturia with or without urgency urinary incontinence symptoms. Patient's will be randomized between 0.01% vaginal estradiol cream with placebo oral pill or daily 50 milligrams oral Mirabegron with a placebo vaginal cream for 12 weeks.
详细描述
Background/significance: Overactive Bladder Syndrome (OAB) is defined as urinary urgency, with or without urgency incontinence, and usually accompanied by frequency and nocturia. OAB remains an increasingly more prevalent disease, affecting over 45% of postmenopausal women over the age 65 within the United States. Epidemiological research continues to consistently highlight OAB's impact on patience's mental health, sleep quality, physical activity, occupational productivity and overall quality of life. OAB's economic burden cannot be overstated as well as a US cost-of-illness study reported a total cost of $66 billion in 2007 and estimated cost of over $82 billion in 2021.
Mainstay first-line forms of management for OAB include behavioral modifications such as bladder training (timed voiding, urge suppression techniques), pelvic floor physical therapy, fluid management and bladder irritant restrictions. Second-line forms of management consistent of pharmacotherapy including oral anticholinergics or beta-3 adrenoreceptor agonists. Multiple studies have shown that vaginal estrogen improves symptoms of urinary urgency and frequency in postmenopausal women. Limited data currently exist comparing beta-3 antagonists to vaginal estrogen use for overactive bladder syndrome as well as the combination of both.
Purpose: This study aims to compare the efficacy of vaginal estradiol with that of oral mirabegron in the treatment of overactive bladder in postmenopausal women and characterize outcomes in women undergoing combined therapy.
Study design: This is a single site, double-blinded, randomized controlled trial for 152 postmenopausal women with urinary frequency, urgency, nocturia with or without urgency urinary incontinence symptoms. Patient's will be randomized between 0.01% vaginal estradiol cream 1/2 gram once nightly for two weeks then three times per week or 50 milligrams oral Mirabegron once a night.
Procedures: Postmenopausal women with bothersome OAB symptoms will be eligible for the study. OAB symptoms will be based on the OAB-q (SF) symptom bother questionnaire with an initial score greater than 20. Other inclusion criteria include ability to speak English. Exclusion criteria include: Post void residual >200mL or >1/3 patient's total bladder volume, currently on or previously taking anticholinergic or beta- 3 antagonists within the past 1 month, untreated, symptomatic pelvic organ prolapse greater than Stage 2, contraindication to vaginal estrogen therapy, contraindication to Mirabegron, undiagnosed postmenopausal vaginal bleeding within the past 12 months, current diagnosis of a condition which explains their overactive bladder or incontinence symptoms.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Investigational Pharmacy will randomize all participants via random allocation rule fixed blocking in a 1:1 ratio into either vaginal estrogen treatment group or oral Mirabegron treatment group. Medication doses will be 0.01% estradiol cream 1/2 gram applied vaginally once nightly for two weeks then three times per week or 50 milligrams oral Mirabegron once daily for twelve weeks which are standard doses. The investigators, patients and clinical staff will be blinded to patient allocation. The patients will receive either a placebo vaginal cream or placebo oral medication depending on their treatment allocation. Medications will be dispensed once for their 12 weeks of therapy. The oral placebo and active medication will be encapsulated in gel capsules with filler to give identical weight and appearance. The vaginal cream placebo (Medisca's VersaPro Cream Base) and active medication will be placed in jars and have similar color, smell, and consistency.
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
- •Raw score of 14 or more on OAB-q SF (adjusted score of 20)
- •Postmenopausal defined by not having a period for 12 months or bilateral oophorectomy a least 12 months status post procedure, or women with prior hysterectomy and preserved ovaries over age 55 years old or having a documented follicle stimulating hormone level greater than 40mIU/mL.
- •Ability to speak and read English
排除标准
- •Contraindications to Vaginal Estrogen or Mirabegron
- •Post void residual >200mL or >1/3 patient's total bladder volume
- •Currently on or previously taking anticholinergic or beta- 3 agonists within the past 1 month
- •Symptomatic pelvic organ prolapse greater than Stage 2, contraindication to vaginal estrogen therapy
- •Undiagnosed postmenopausal vaginal bleeding within the past 12 months
- •Current diagnosis of Multiple sclerosis, Parkinson's Disease, prior spinal cord injury, Spina Bifida, prior pelvic irradiation, Interstitial Cystitis, recurrent urinary tract infection.
研究组 & 干预措施
Vaginal Estradiol with placebo oral pill
Patient will receive 0.01% estradiol cream 1/2 gram applied vaginally once nightly for two weeks then three times per week with once daily placebo oral pill
干预措施: Vaginal estrogen (Drug)
Oral Mirabegron with placebo vaginal cream
Patient will receive 50 milligrams oral Mirabegron once daily and placebo vaginal cream (Medisca's VersaPro Cream Base) once nightly for two weeks then three times per week
干预措施: Mirabegron 50 MG [Myrbetriq] (Drug)
结局指标
主要结局
OAB-q short form (SF) symptom bother scores
时间窗: 12 weeks
Primary Aim: Compare changes in the six-item OAB-q short form (SF) symptom bother scores from baseline to 12 weeks post treatment in postmenopausal women who receive either vaginal estradiol or Mirabegron. We will also compare 12-weeks post treatment OAB-q SF symptom bother scores after single therapy trials with patients who desire combined therapy for another 12 weeks. The OAB-q SF symptom bother questionnaire is based on six individual questions a 6-point scale ranging from 1 or "not at all" to 6 or "a very great deal." Per the guidance of the scoring manual, the raw scores are converted into scores ranging from 0 to 100 (0 being the minimum score and 100 being the maximum score.) The higher the score signifies that the patient has worse bothersome overactive bladder symptoms. The conversion to a 100 point scale is based on the equation as follows: ((Raw score - 6) / 36) x 100.
次要结局
- health-related quality of life (HRQL) of the OAB-q SF scores(12 weeks)
- Patient Global Impression of Severity (PGI-S) scores(12 weeks)
- Patient Global Impression of Improvement (PGI-I) scores(12 weeks)
- Number of voids(12 weeks)
- Number of urge incontinence episodes(12 weeks)
研究者
Christopher W. Heuer, DO
Principal Investigator
Walter Reed National Military Medical Center