A Multi-center, Open-label, Dose-titration Pilot Study Evaluating the Efficacy and Safety of Oxybutynin Transdermal Systems in Patients With Neurogenic Bladder Resulting From Spinal Cord Injury
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 24
- 主要终点
- Average Number of Catheterizations Without Leaking Per Day
研究概览
简要总结
This study will evaluate the efficacy and safety of an anticholinergic drug treatment administered by transdermal patch to treat overactive bladder in adults who have spinal cord injury.
详细描述
The Dose Titration Period began with a 3.9 mg/day or 7.8 mg/day as a starting dose after the completion of a 3-day diary for baseline evaluations, including urodynamic testing. The clean intermittent catheterization (CIC) frequency remained constant throughout the Dose Titration Period. The dose was adjusted every two weeks during the Dose Titration Period by increasing one dose level, at the investigator's discretion, based on the patient's symptoms. If a patient achieved complete continence and reported tolerable or absence of side effects, the patient was continued at that dose for the duration of the 8-week Titration Period. If a patient reported unacceptable side effects, the dose was reduced by one level. This reduced dose was considered the maximum tolerable dose for the patient and the patient continued at that dose for the duration of the 8-week Titration Period. The dose levels evaluated were 3.9 mg/day, 7.8 mg/day, 9.1 mg/day, and 11.7 mg/day. Of the 22 subjects in the modified intent-to-treat population evaluated for efficacy, 0 were in the 3.9 mg/day dose group, 3 were in the 7.8 mg/day dose group, 8 were in the 9.1 mg/day dose group, and 11 were in the 11.7 mg/day dose group.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •At least 18 years of age at day of consent;
- •Is a male, or is a non-pregnant non-lactating female who is either of non-child-bearing potential, or is using adequate means of birth control;
- •Has a h/o of urinary incontinence from neurogenic bladder of spinal cord injury etiology;
- •Has impairment based on the American Spinal Injury Association (ASIA);
- •Use clean intermittent catheterization;
- •Has urinary incontinence between scheduled catheterization;
- •Capable of understanding and complying with the protocol.
排除标准
- •Have one or more treatable conditions, other than neurogenic bladder dysfunction, that may cause urinary incontinence or urgency;
- •Have any medical condition that precludes their participation in the study, or may confound the outcome of the study;
- •History of major lower urinary tract surgery, procedures;
- •Has an active skin disorder, affecting TDS application site areas;
- •Hypersensitivity to the investigational drug;
- •Has participated in any study involving administration of an investigational compound within 30 days before this study.
研究组 & 干预措施
Oxybutynin transdermal system
Oxybutynin transdermal system 3.9 mg/day, 7.8 mg/day, 9.1 mg/day or 11.7 mg/day dosing
干预措施: Oxybutynin transdermal system (Drug)
结局指标
主要结局
Average Number of Catheterizations Without Leaking Per Day
时间窗: 8 weeks
Baseline in number of daily catheterizations without leaking per day as recorded in a 3-day urinary diary.
次要结局
- Patch Adhesion(8 weeks)
- Urodynamic Measurements(8 weeks)
- Urinary Leakage and Catheterization Data(8 weeks)