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临床试验/NCT00498888
NCT00498888已完成不适用

Is the a Difference Between Rehabilitation Treatment, Pelvic Floor Muscle Training, Bladder Training and Anticholinergic Drug Treatment in UUI in the Long Term: A Study of Impairment, Quality of Life, and Cost Effectiveness

Assuta Hospital Systems2 个研究点 分布在 1 个国家目标入组 164 人开始时间: 2007年6月1日最近更新:
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适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
164
试验地点
2
主要终点
Number of micturitions in a 24 hour bladder diary and number of urge urinary incontinence episodes by subjects' reports per week.
研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

  • Urinary Urge Incontinence (UUI) is the involuntary urine loss associated with a strong sensation to void.
  • UUI usually associated with reduced bladder capacity.
  • The pathophysiology is unclear.
  • Pelvic floor muscle dysfunction and detrusor instability have been suggested as possible mechanisms.
  • Standard treatment includes anticholinergic medication and behavior modification.
  • The study aims to compare the long term effectiveness of 4 different approaches to the treatment of women with Urge Urinary Incontinence (UUI):
  1. Pelvic Floor Rehabilitation (includes muscle training+behavioral intervention+bladder training)
  2. Pelvic Floor muscle training alone
  3. Bladder Training alone
  4. Drug treatment with Tolterodine.
  • Study variables will include: impairment ratings, quality of life, and cost-effectiveness.
  • This study addresses three issues:
  1. The long term efficacy and cost-effectiveness of the various treatment options.
  2. To identify the factors involved in determining the effectiveness of drug or behavioral therapy.
  3. The pathophysiology of UUI. By subdividing the rehabilitation group into 3 arms, we hope to shed light on the mechanism of dysfunction. A better response in one group will help localize the problem to pelvic floor muscles or to detrusor instability.

详细描述

The study has 3 phases: Before treatment (phase I), immediately after 3 months of treatment (phase II), and 1 year post-entry (phase III)

Women with UUI will be divided randomly into one of the four treatment groups. Every subject will participate in 4 visits. The drug group treatment consists of administration of tolterodine SR 4 mg daily for 3 months. Subjects who assigned to the pelvic floor rehabilitation, pelvic floor muscle training, and bladder training groups will be treated via 4 visits to a physical therapist, who is trained in the procedures. The chief researcher (RK) will be blinded to the treatment groups and will perform the outcome measures in all phases.

Study variables will include impairment ratings, quality of life, and cost-effectiveness

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Investigator)

入排标准

年龄范围
45 Years 至 75 Years（Adult, Older Adult）
性别
Female
接受健康志愿者
是

入选标准

  • •complaints of urinary leakage > 3 in last month (not stress incontinence)
  • •functionally independent subjects

排除标准

  • •urinary tract infection
  • •urogenital prolapse
  • •unstable diabetes
  • •neurological or psychiatric disease
  • •narrow angle glaucoma
  • •after colposuspension or sling surgery
  • •Mini Mental State Examination <24

结局指标

主要结局

Number of micturitions in a 24 hour bladder diary and number of urge urinary incontinence episodes by subjects' reports per week.

时间窗: Phase I, II, and III

次要结局

  • cost-effectiveness(1 year)
  • Health service utilization(1 year)
  • underclothing pad use(Phase I, II, and III)
  • change in physical activity and smoking(Phase I, II, and III)
  • missed days at work(1 year)
  • Maximum voided volume, as obtained from 24 hours bladder diary(Phase I, II, III)
  • side effects from list of 10 possible effects: dry mouth, constipation, side effects from list of 10 possible effects: dry mouth, constipation, sleepiness, fatigue, blurred vision, dizziness, urinary difficulty, tachycardia, headache and low back pain(Phase I, II, and III)
  • quality of life measured by I-QoL(Phase I, II, and III)
  • visual analogue scale (VAS) use in urogynecological research(Phase I, II, and III)
  • Incontinence Severity Index (ISI)(Phase I, II, and III)
  • functional status as measured by Late Life Function and Disability Instrument(Phase I, II, and III)
  • Depression status as measured by Center for Epidemiological Studies Depression scale (CES-D)(Phase I, II, and III)
  • Cost benefit(1 year)
  • Maximum voluntary contraction fo pelvic floor muscle, graded 1-5 by Oxford scale(Phase I, II, and III)

研究者

发起方
Assuta Hospital Systems
申办方类型
Other
责任方
Principal Investigator
主要研究者

rachel kafri

Maccabi Healthcare Services

Assuta Hospital Systems

研究点 (2)

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