Higher Neural and Cognitive Changes Following Anticholinergic Versus Beta 3 Agonist Versus Placebo Treatments in Female Patients With Overactive Bladder: a Multicenter Randomized Controlled Pilot Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- Functional connectivity on MRI
研究概览
简要总结
Women presenting with overactive bladder symptoms will be randomized to one of 3 arms (anticholinergic, beta-3 agonist, placebo). They will undergo baseline cognitive testing, functional MRI of the brain. Cognitive testing and functional MRI will be repeated after taking their double blinded intervention for 30 days.
详细描述
Women presenting to the urology clinic with complaints of urinary urgency, frequency in the absence of urinary tract infection or other obvious pathology will be screened for inclusion/exclusion criteria. Qualifying subjects will be consented.
Baseline health information, bladder symptom questionnaires (Overactive Bladder-questionnaire(OABq), Patient Perception of Bladder Condition (PPBC)), Personal Health Questionnaire-9 (PHQ-9),Hamilton Anxiety Rating Scale (HAM-A), Montreal cognitive assessment (MoCA) will be given. If baseline depression (PHQ-9 score 15 or greater),dementia (MoCA score 25 or less), anxiety (HAM-A score 25-30) are noted the subject is excluded. 15 patients will be recruited from Baylor Scott & White Health Urology clinic, and 15 patients will be recruited from Houston Methodist Urology clinic.
They will schedule a date within 1 month for the Rey Auditory Verbal Learning Test (RAVLT) and brain functional MRI (fMRI). RAVLT test is performed, followed by resting state fMRI and memory task during fMRI. Vials of medication will be distributed. Vials will be labeled 1-30 and will contain 30 tablets each. The anticholinergic and beta-3 agonist tablets will be encapsulated to look identical to the placebo tablet. Subjects will be reimbursed at this visit. fMRI images at baseline and post-intervention will be analyzed by a radiologist for incidental findings.
One week and two weeks after initiating their tablets, phone interviews will inquire about pill count, side effects, and any new medications. Follow up testing date will be scheduled during the call. The same questions will be repeated at completion of the tablets (30 days after initiation).
At completion of the tablets, subjects return to Houston Methodist for repeat RAVLT and fMRI. Subjects will be reimbursed the other half of their compensation at this visit.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Randomization using a random number system will be performed by the compounding pharmacy. Records linking subject number to their allocation will be kept by the pharmacy, inaccessible to the investigator, patient, care providers.
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Female patients of age 50 to 90 years old with OAB as defined by the International Continence Society (Urgency with or without urge incontinence, usually with frequency and nocturia in the absence of urinary tract infection or other obvious pathology) who report that symptoms cause moderate problems using the PPBC.
- •English-speaking and able to consent
排除标准
- •Males are excluded to eliminate prostate pathology and urethral strictures, as well as possible bias of gender differences on fMRI.
- •Subjects with moderately severe or severe depression (screening score of 15 or more) on the Personal Health Questionnaire-9 (PHQ-9)
- •Subjects with moderate to severe anxiety (screening score 25-30) on the Hamilton Anxiety Rating Scale (HAM-A)
- •A screening score indicating below normal cognitive function at baseline (score of 25 or less) on the montreal cognitive assessment.
- •Subjects with neurologic disorders, dementia, prior cerebrovascular accident, neurogenic bladder or post-void residual greater than 250 mL
- •Anticholinergics for OAB or beta 3 agonists use for treatment of OAB in the preceding six months prior to enrollment
- •Pregnant or planning to become pregnant in the next six months, or current breastfeeding
- •The inability to undergo MRI
研究组 & 干预措施
Placebo
Placebo pill identical will be identical to tablets in the other 2 arms.
干预措施: Functional magnetic resonance imaging (fMRI) (Diagnostic Test)
Placebo
Placebo pill identical will be identical to tablets in the other 2 arms.
干预措施: Rey Auditory Verbal Learning Test (RAVLT) (Diagnostic Test)
Anticholinergic
Solifenacin 5 mg tablet orally once daily for 30 days
干预措施: Anticholinergic (Drug)
Anticholinergic
Solifenacin 5 mg tablet orally once daily for 30 days
干预措施: Functional magnetic resonance imaging (fMRI) (Diagnostic Test)
Anticholinergic
Solifenacin 5 mg tablet orally once daily for 30 days
干预措施: Rey Auditory Verbal Learning Test (RAVLT) (Diagnostic Test)
Beta-3 agonists, adrenergic
Mirabegron 25 mg tablet orally once daily for 30 days
干预措施: Beta-3 Agonists, Adrenergic (Drug)
Beta-3 agonists, adrenergic
Mirabegron 25 mg tablet orally once daily for 30 days
干预措施: Functional magnetic resonance imaging (fMRI) (Diagnostic Test)
Beta-3 agonists, adrenergic
Mirabegron 25 mg tablet orally once daily for 30 days
干预措施: Rey Auditory Verbal Learning Test (RAVLT) (Diagnostic Test)
结局指标
主要结局
Functional connectivity on MRI
时间窗: 29 +/-1 days
Functional connectivity during a word recognition task will be compared within subjects from baseline and after 29+/- 1 day of intervention medication.
Diffusion tensor imaging
时间窗: 29 +/-1 days
Fractional anisotropy and mean diffusivity from diffusion tensor images will be compared within subjects from baseline and after 29+/- 1 day of intervention medication.
Resting state blood oxygenation level dependent (BOLD)changes
时间窗: 29 +/-1 days
During resting state, BOLD changes will be compared within subjects from baseline and after 29+/- 1 day of intervention medication.
次要结局
- Score on Rey Auditory Verbal Learning Test (RAVLT)(30 days)
- Patient Perception of Bladder Condition (PPBC)(30 days)
- Overactive bladder questionnaire (OAB-q)(30 days)