Iowa Pelvic Floor Disorders Clinical Trials Network

尿急和混合性尿失禁是常见疾病，影响10-20%的美国女性。虽然存在几种治疗方式，但药物治疗仍然是治疗的主要手段。许多与急迫性和混合性尿失禁治疗相关的研究受限于随访时间短、患者人群同质、严格的排除标准、定义不明确的结局指标以及缺乏安慰剂对照。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的是描述和比较几种治疗急迫性和混合性尿失禁的疗效（1期）和长期有效性（2期），以确定治疗前尿动力学的预测价值，并了解与治疗疗效和有效性相关的因素。将400名患有急迫性尿失禁或以急迫性尿失禁为主要症状的混合性尿失禁的妇女随机分配到四个治疗组之一：（1）托特罗定，（2）物理疗法加安慰剂，（3）物理疗法加托特罗定，和（4）单独的安慰剂。用于定义3个月（1期）治疗疗效的主要结局指标是每周失禁发作次数（至少60次）较基线减少至少50%。次要结局指标包括（1）排尿频率，（2）在视觉模拟量表上记录的患者满意度，（3）不良事件，（4）急迫性尿失禁特定生活质量指标，（5）骨盆底不适量表，（6）性功能评估工具，和（7）一般生活质量指标。在评价第1阶段结局后，将继续每3个月对女性进行一次随访，持续1年。治疗不成功的妇女将接受替代治疗。将通过比较基线和一年的结局指标来描述急迫性和混合性尿失禁治疗的中期（一年）有效性。所有数据将以意向治疗方式进行分析。本研究的具体目的是：1）描述和比较上述4组中急迫性尿失禁治疗的3个月和1年疗效，2）确定特定的治疗前尿动力学变量是否可预测治疗疗效，3）确定与治疗疗效相关的因素，和4）描述治疗组之间的临床病程和生活质量的差异以及与干预3个月和1年后的基线相比的差异。

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.