Iowa Pelvic Floor Disorders Clinical Trials Network

爱荷华州盆底疾病临床试验网络

• 批准号: 6943071
• 负责人: Karl J Kreder
• 金额: $ 43.49万
• 依托单位: UNIVERSITY OF IOWA
• 依托单位国家: 美国
• 财政年份: 2001
• 资助国家: 美国
• 起止时间: 2001-09-01 至 2008-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6943071
• 关键词: adult human (21+); anticholinergic agent; antispasmodic agents; clinical trials; combination therapy; cooperative study; drug adverse effect; female; human subject; human therapy evaluation; longitudinal human study; medical rehabilitation related tag; outcomes research; pathologic process; patient oriented research; pelvis; personal log /diary; physical therapy; quality of life; questionnaires; rehabilitation; satisfaction; sex behavior; urinary incontinence; urinary tract disorder chemotherapy; urinary tract pharmacology; urination; urination disorder; women' s health

Urge and mixed urinary incontinence are common conditions, affecting 10-20% of American women. While several treatment modalities exist, pharmacotherapy remains the mainstay of treatment. Much of the research pertaining to treatment for urge and mixed incontinence is limited by short duration of follow-up, homogeneous patient populations, stringent exclusion criteria, poorly defined outcome measures, and lack of placebo control. Factors that predict success or failure of specific treatments are poorly understood. The broad objectives of this prospective randomized clinical trial are to describe and compare the efficacy (Phase 1) and the longer term effectiveness (Phase 2) of several treatments for urge and mixed incontinence, to determine the predictive value of pre-treatment urodynamics, and to understand factors associated with treatment efficacy and effectiveness. 400 women with urge incontinence or mixed incontinence with urge as the predominant symptom will be randomly assigned to one of four treatment groups: (1) tolterodine, (2) physiotherapy plus placebo, (3) physiotherapy plus tolterodine, and (4) placebo alone. The primary outcome measure used to define treatment efficacy at three months (Phase 1) is at least a 50% reduction from baseline in the number of incontinent episodes per week (of at least 60. Secondary outcomes measures include (1) voiding frequency, (2) patient satisfaction as recorded on a visual analogue scale, (3) adverse events, (4) urge incontinence specific quality of life measure, (5) pelvic floor distress inventory, (6) sexual function assessment tool, and (7) generic quality of life measure. Following evaluation of Phase 1 outcomes, women will continue to be followed every 3 months for 1 year. Women unsuccessfully treated will be offered alternative therapy. Medium term (one year) effectiveness of treatments for urge and mixed incontinence will be described by comparing baseline and one-year outcome measures. All data will be analyzed in an intent-to-treat fashion. The specific aims of this study are 1) to describe and compare the 3- month and 1-year efficacy of urge incontinence treatment among the 4 groups stated above, 2) to determine whether specific pre-treatment urodynamic variables are predictive of treatment efficacy, 3) to identify factors associated with treatment efficacy, and 4) to describe the difference in clinical course and quality of life among treatment groups and as compared to baseline after 3 months and 1 year of intervention.

敦促和混合尿失禁是常见的情况，影响了10-20％的美国妇女。尽管存在几种治疗方式，但药物治疗仍然是治疗的主要手段。与冲动和混合失禁有关的治疗有关的大部分研究受到随访时间短，均质患者人群，严格的排除标准，定义不明的结果指标以及缺乏安慰剂控制的限制。预测特定治疗成功或失败的因素知之甚少。这项前瞻性随机临床试验的广泛目标是描述和比较几种治疗方法的功效（第1阶段）和长期有效性（阶段2），以确定预处理前尿动力学的预测价值，并了解与治疗功效和有效性相关的因素。 400名急性尿失禁或混合尿失禁的妇女将随机分配给四个治疗组之一：（1）Tolterodine，（2）物理疗法加安慰剂，（3）Physiotherapy Plus tolterodine，and Tolterodine和（4）单独的安慰剂。 The primary outcome measure used to define treatment efficacy at three months (Phase 1) is at least a 50% reduction from baseline in the number of incontinent episodes per week (of at least 60. Secondary outcomes measures include (1) voiding frequency, (2) patient satisfaction as recorded on a visual analogue scale, (3) adverse events, (4) urge incontinence specific quality of life measure, (5) pelvic floor distress inventory, (6) sexual评估工具和（7）一般的生活质量措施。在1年内，妇女将继续遵循每3个月的妇女。描述和比较上述四个组中急流尿失禁治疗的3个月和1年功效，2）确定特定的预处理前尿动力学变量是否可以预测治疗效率，3）识别与治疗功效相关的因素，以及4）以描述治疗组和基础临床课程差异与基础之间的差异和3个月后的差异。