Iowa Pelvic Floor Disorders Clinical Trials Network

刺激性和混合性尿失禁是常见的疾病，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方式。许多关于急迫性和混合性尿失禁治疗的研究受到以下因素的限制：随访持续时间短、患者群体同质性、严格的排除标准、不明确的结果衡量标准以及缺乏安慰剂对照。人们对预测特定治疗成败的因素知之甚少。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急迫性和混合性尿失禁的疗效(第一阶段)和长期疗效(第二阶段)，确定治疗前尿动力学的预测价值，并了解与治疗效果和有效性相关的因素。400名以急迫性尿失禁或混合性尿失禁为主要症状的女性将被随机分配到四个治疗组中：(1)托特罗定组，(2)物理疗法+安慰剂组，(3)物理疗法+托特罗定组，以及(4)单独安慰剂组。用于确定三个月(第一阶段)治疗效果的主要结果衡量标准是每周大小便失禁发作次数比基线至少减少50%(至少60次)。次要结果测量包括：(1)排尿频率，(2)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测量，(5)盆底窘迫问卷，(6)性功能评估工具，和(7)一般生活质量测量。在评估了第一阶段的结果后，将继续每3个月对妇女进行为期一年的跟踪调查。治疗不成功的女性将被提供替代疗法。通过比较基线和一年的结果来描述急迫性和混合性尿失禁治疗的中期(一年)效果。所有数据都将以意向处理的方式进行分析。这项研究的具体目的是：1)描述和比较上述4组急迫性尿失禁治疗3个月和1年的疗效，2)确定特定的治疗前尿动力学指标是否可以预测治疗效果，3)确定与治疗效果相关的因素，4)描述治疗组之间的临床病程和生活质量的差异，以及干预3个月和1年后与基线的比较。

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.