Randomized Double Blinded Placebo-controlled Trial of the Once Daily 5mg Dose of Solifenacin Succinate vs. Placebo in Inner City Women Ages 20-45 With Overactive Bladder
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- 15% reduction in the amount of voids in a 24 hour period
研究概览
简要总结
In this study we hope to establish the prevalence of urinary urge symptoms (with or without incontinence) in a multicultural, underserved, hospital clinic population in women between the ages of 20 and 45. Quality of life (QOL) in these individuals will be examined. The goal is to show a 15% reduction in number of voids in a 24 hour period in our study population after 12 weeks of treatment with solifenacin succinate.
Hypothesis: We believe that urinary urge symptoms are under-reported in young women and believe they pose a significant strain on quality of life on otherwise young, healthy individuals. Treatment with solifenacin succinate will improve symptoms, in turn improving QOL for these individuals.
详细描述
- Study type: 1) Prospective, questionnaire based study 2) Randomized, double blinded, placebo-controlled trial
- Setting: OB-GYN, general medicine, and family medicine clinics at the Stamford Optimus Health Clinic in association with The Stamford Hospital Department of OB-GYN.
- Study population: Pre-menopausal women, ages 20-45
- Number of patients: 40 in each treatment arm (n=80)
- Recruitment: Questionnaire based, handed out by our research assistant to any women visiting Optimus Health Clinics (general medicine, family medicine, and OB-GYN) regardless of reason for visit. Follow up visits for qualifying individuals will be held in the department of OB-GYN at The Stamford Hospital.
Subject Compensation: Subjects will receive $10 for filling out the initial questionnaires. If the subject proceeds to the treatment arm of the study, they will be given $50 a month (total of $150) during the 90 day treatment period.
- Study Treatment: Placebo-controlled medical treatment with solifenacin succinate, 5mg PO Qday x 90 days.
- Randomization/blinding method/drug administration: The Stamford Hospital pharmacy will be in charge of blinding treatment to both researchers and study population. The drug and placebo will both be stored and administered by the pharmacy. A computer randomization software will be used by the pharmacy to randomize patients. The subjects will be dispensed a one month supply of drug/placebo at a time. The subsequent months refill will be administered only if the patient brings the original container back to the pharmacy so that compliance can be tracked. Both placebo and solifenacin succinate will be supplied by Astellas Pharmaceuticals and will look identical.
- Primary endpoint: subjects will remain in study up to 120 days (90 days of treatment, and up to 30 days allotted for scheduling initial visit, history and physical, obtaining consent, etc).
- Primary Goal: 15% reduction in the number of voids in a 24 hour period after 12 weeks of treatment with Solifenacin succinate.
- Secondary Goals:
- Determining prevalence of urinary urge symptoms in pre-menopausal women ages 20-45.
- Assessing quality of life prior to treatment with respect to urge symptoms, then monitoring for improvement after treatment.
- Decreases in the relative number of episodes of: urgency, nocturia (defined as waking 1 or more times to urinate per night14), and incontinence.
- Reported (using 3-day diary) medical side effects including: complaints of dry mouth, constipation, and blurred vision.
Statistical Considerations:
With the above stated worldwide urinary urge symptom prevalence found to be 16-17%, we are attempting to show a reduction of 15% in urinary urge symptoms, using an alpha of 0.05 with a power of 80%. Calculated sample size was determined to be 68, 34 in the medical arm and 34 in the placebo arm. The overall goal for enrollment will be increased to 80 to account for possible study drop outs.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Score of 8 or greater on the OAB-V8 questionnaire
- •Women between the ages of 20 and 45 years.
- •Pre-menopausal
- •Not Pregnant or plan on becoming during the length of the study
排除标准
- •menopause
- •pregnancy (including women breastfeeding, or women planning on becoming pregnant during the study); a pregnancy test will be performed prior to starting treatment.
- •previous diagnosis of stress urinary incontinence or mixed urinary incontinence
- •previous diagnosis of diabetes mellitus/diabetes insipidus
- •use of diuretics
- •neurological cause for detrusor instability
- •medical condition contraindicating antimuscarinic use (i.e.: narrow angle glaucoma)
- •urinary tract infection/cystitis/bladder stones (at time of questionnaire).
- •taking any of the following contraindicated drugs:
- •phenothiazines: fluphenazine or fluphenazine decanoate, prochlorperazine maleate, promethazine, chlorpromazine, perphenazine, thioridazine, trifluoperazine, prochlorperazine edisylate,
- •potassium salts: potassium acid phosphate, potassium citrate, potassium chloride, potassium iodide, potassium phosphate/sodium potassium.
研究组 & 干预措施
solifenacin succinate
Group randomized into solifenacin succinate treatment
干预措施: solifenacin succinate (Drug)
placebo
Group randomized into placebo
干预措施: placebo (Drug)
结局指标
主要结局
15% reduction in the amount of voids in a 24 hour period
时间窗: 90 days
次要结局
- Assessing quality of life prior to treatment with respect to urge symptoms, then monitoring for improvement after treatment.(90 days)