Extended-Release Oxybutynin in the Treatment of Neurogenic Detrusor Overactivity (RONDO)
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 发起方
- 入组人数
- 17
- 主要终点
- Maximal Detrusor Pressure
研究概览
简要总结
The purpose of this study is to evaluate the effects and tolerability (how well a participant can stand a particular medicine or treatment) of flexible dose Oxybutynin Extended-Release (OXY-ER, Lyrinel) including safety and quality of life assessment in participants with neurogenic detrusor overactivity (NDO - the nerves mediating the detrusor muscle do not work properly leading to frequent feeling of need to urinate during the day, night, or both).
详细描述
This is an open-label (all people know the identity of the intervention), single arm, prospective (study following participants forward in time), multi-center study of participants with NDO. The initial dose of Oxybutynin ER will be 10 milligram (mg) and will be titrated to a maximum of 30 mg. Dosage will be adjusted in 5-mg increments at approximately 14-day intervals until continence is achieved or the participant cannot tolerate side effects. The duration of participation in the study will be 12 weeks. The study will consist of 6 visits: baseline, Weeks 2, 4, 6, 8 and 12. Week 4 and Week 8 will be telephone visits. Overall safety and efficacy of Oxybutinin ER will be assessed as well as safety and efficacy during the titration and maintenance phases. The efficacy of treatment will be assessed using urodynamic parameters (the force and flow of urine) and clinical parameters (voiding diary and catheterization [use or insertion of a tubular device to drain the bladder] schedules). The quality of life will also be monitored in the study.
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
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
- •Diagnosis of overactive bladder as a result of neurogenic condition, for example following spinal cord injury, multiple sclerosis (slowly worsening disorder of the central nervous system that causes symptoms such as weakness, incoordination, numbness, problems talking and problems seeing), Parkinson's disease (a progressive disorder of the central nervous system, seen usually in older persons, in which there is slow movement [due to muscle weakness], trembling and sweating), or cerebrovascular accidents (CVAs - stroke-sudden loss of blood supply to brain)
- •Women must not be pregnant and be of either non-childbearing potential or is using adequate means of birth control
- •Overactive bladder symptoms and/or has urge incontinence episodes
- •Must have normal results on urine culture tests and on urinalysis
- •ECOG (Eastern Cooperative Oncology Group) performance status score of less than or equal to 3
排除标准
- •Participants with 1 or more treatable or conditions, other than neurogenic bladder dysfunction, that may cause urinary incontinence or urgency
- •Any medical or unstable condition that precludes their participation in the study or may confound the outcome of the study (participants with or at risk for urinary retention, gastric retention or uncontrolled narrow angle; heart failure or kidney failure; diabetes mellitus; abnormal muscle weakness [myasthenia gravis]; paralysis or inactivity in the intestines that prevents material moving through the gut [intestinal atony or paralytic ileus]; severe inflammation of the bowel [ulcerative colitis] sudden expansion of the large intestine seen in advanced ulcerative colitis or Crohn's disease [toxic megacolon]; history of major lower urinary tract surgery [transurethral resection will be excluded])
- •Hypersensitivity to the investigational drug or any of its ingredients (eg, lactose)
- •Pregnant or breast feeding female
- •Significant bacteriuria (presence of bacteria in the urine) or pyuria (presence of white blood cells) in the urine
研究组 & 干预措施
Oxybutynin Extended-Release
Oxybutynin chloride 5, 10, 15 milligram (mg) per tablet 10-30 mg per day orally
干预措施: Oxybutinin Extended-Release (Drug)
结局指标
主要结局
Maximal Detrusor Pressure
时间窗: Week 12
Maximal detrusor pressure represents the maximum pressure (peak amplitude) in the bladder during the first involuntary contraction of the bladder muscle. Detrusor pressure is the component of intravesical (in the bladder) pressure that is created by forces in the bladder wall (passive and active). It was estimated by subtracting abdominal pressure from intravesical pressure.
次要结局
- Maximal Cystometric Capacity (MCC)(Baseline and Week 12)
- Detrusor Leakpoint Pressure(Baseline and Week 12)
- Post-Void Residual Urine Volume(Baseline and Week 12)
- Reflex Volume(Baseline and Week 12)
- Urge Incontinence Episodes(Baseline, Week 4 and Week 12)
- Total Incontinence Episodes(Baseline, Week 4 and Week 12)
- Percentage of Participants With no Episodes of Urge-Urinary Incontinence(Baseline, Week 4 and Week 12)
- King Health Questionnaire Score(Baseline and Week 12)