Comparative Urine Proteomic Studies of Overactive Bladder in Humans
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 21
- 试验地点
- 1
- 主要终点
- Bladder Diary to Assess Urinary Frequency at Baseline and at End of 6-week Treatment
研究概览
简要总结
This study is being done to evaluate the use of a new technology (urine proteomics) - the study of proteins in the urine to identify urine markers of overactive bladder (OAB) from a simple voided urine specimen.
详细描述
The objectives of the study are:
- to improve the diagnosis of overactive bladder using a non-invasive technology (urine proteomics) and
- to study how potential urine biomarkers changes with overactive bladder symptoms after patients have been treated with fesoterodine, an FDA approved drug for the treatment of overactive bladder.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 盲法
- None
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
- •For healthy volunteers the inclusion criteria are:
- •Females ≥ 18 years old
- •Not experiencing overactive bladder symptoms
- •Not experiencing frequency or urgency
- •For overactive bladder patients the inclusion criteria are
- •Females ≥ 18 years old
- •Overactive bladder symptoms for ≥ 3 months before screening ) Recurrent urinary tract infections (UTIS) > 3/year
排除标准
- •For healthy volunteers the exclusion criteria are:
- •Overactive bladder symptoms, such as frequency and urgency
- •Intermittent/unstable use of bladder medications
- •Pregnant women or women unwilling to use contraceptives
- •Neurological conditions: stroke, Multiple Sclerosis (MS), Parkinson's, spinal cord injury
- •Significant pelvic organ prolapsed (grade 3 or above based on physical exam)
- •Lower urinary tract surgery within past 6 months
- •Known history of IC or pain associated with OAB
- •Urinary retention requiring catheterization, indwelling catheter of Self-cath
- •Recurrent UTIS > 3/year
- •For overactive bladder patients the exclusion criteria are:
- •Contraindications to Fesoterodine use such as hypersensitivity, GI and urinary retention, and Glaucoma
- •Intermittent/unstable use of bladder medications
- •Pregnant women or women unwilling to use contraceptives
- •Neurological conditions: stroke, MS, Parkinson's, spinal cord injury
- •Significant pelvic organ prolapsed (grade 3 or above based on physical exam)
- •Lower urinary tract surgery within past 6 months
- •Known history of Interstitial Cystitis (IC) or pain associated with OAB
- •Urinary retention requiring catheterization, indwelling catheter of Self-cath
- •Recurrent urinary tract infections (UTIS) > 3/year
- •Deferral Criteria:
- •Treatment with OAB medications within 2 weeks before baseline visit. If patient is currently on OAB medications the patient will be asked to stop OAB medication for 2 weeks and return for baseline visit.
研究组 & 干预措施
Fesoterodine
Females with overactive bladder symptoms will be given Fesoterodine 4 mg. daily for six weeks.
干预措施: fesoterodine (Drug)
结局指标
主要结局
Bladder Diary to Assess Urinary Frequency at Baseline and at End of 6-week Treatment
时间窗: Outcome measure was assessed at baseline and at the end of the 6-week treatment
Overactive bladder subjects filled out a 3-day bladder diary before starting Fesoterodine and another 3-day bladder diary at the end of taking 6 weeks of Fesoterodine. The bladder diary was used to assess urinary frequency. The average number of urinations (frequency) per day over a period of 3 days before the start of medication and at the end of 6 weeks of medication were compared for each subject and then as a group.
Bladder Diary (Using Urinary Sensation Scale Found in Bladder Diary) to Assess Urinary Urgency at Baseline and at 6-week Treatment
时间窗: Outcome measure was assesses at baseline and at the end of the 6-week treatment period.
The Urinary Sensation Scale found in the bladder diary given to subjects was used to assess urinary urgency. The Urinary Sensation Scale was filled out by the subject for 3 days before starting Fesoterodine and filled out again for 3 days at the end of taking 6 weeks of Fesoterodine. The scale ranges from 1 (no feeling of urgency), 2 (mild), 3 (moderate), 4 (severe) to 5 (unable to hold; leak urine). The urgency scale with the most check marks per day over a period of 3 days before start of medication was averaged for each subject. The urgency scale with the most check marks per day over a period of 3 days at the end of taking 6 weeks of medication was averaged for each subject. Then, the average before start of medication for all subjects and the average at the end of taking 6 weeks of medication for all subjects were compared.
次要结局
- Overactive Bladder Questionnaire (OAB-q) to Assess Bother From Urinary Frequency at Baseline and at 6 Weeks.(Outcome measure was assessed at baseline and after the 6 week visit.)
- Overactive Bladder Questionnaire (OAB-q) Will be Used to Assess Bother From Urinary Urgency at Baseline and at 6 Weeks..(Outcome measures were assessed at baseline and after the 6 week visit.)