incontinence 尿失禁
Continence pessary compared with behavioral therapy or combined therapy for stress incontinence: a randomized controlled trial.
机构信息
From the University of Alabama at Birmingham, Birmingham, Alabama; Birmingham VA Medical Center, Birmingham, Alabama; Loyola University, Maywood, Illinois; University of Utah, Salt Lake City, Utah; University of Michigan, Ann Arbor, Michigan; Duke University, Durham, North Carolina; University of Iowa, Iowa City, Iowa; Johns Hopkins School of Medicine, Baltimore, Maryland; Duquesne University, Pittsburgh, Pennsylvania; Magee-Womens Hospital, Pittsburgh, Pennsylvania; University of California San Diego, San Diego, California; University of Texas Southwestern, Dallas, Texas; Cleveland Clinic, Cleveland, Ohio; and National Institutes of Health, Bethesda, Maryland.
出版信息
Obstet Gynecol. 2010 Mar;115(3):609-617. doi: 10.1097/AOG.0b013e3181d055d4.
OBJECTIVE
To compare the effectiveness of a continence pessary to evidence-based behavioral therapy for stress incontinence and to assess whether combined pessary and behavioral therapy is superior to single-modality therapy.
METHODS
This was a multisite, randomized clinical trial (Ambulatory Treatments for Leakage Associated with Stress Incontinence [ATLAS]) that randomly assigned 446 women with stress incontinence to pessary, behavioral therapy, or combined treatment. Primary outcome measures, at 3 months, were Patient Global Impression of Improvement and the stress incontinence subscale of the Pelvic Floor Distress Inventory. A priori, to be considered clinically superior, combination therapy had to be better than both single-modality therapies. Outcome measures were repeated at 6 and 12 months. Primary analyses used an intention-to-treat approach.
RESULTS
At 3 months, scores from 40% of the pessary group and 49% of the behavioral group were "much better" or "very much better" on the Patient Global Impression of Improvement (P=.10). Compared with the pessary group, more women in the behavioral group reported having no bothersome incontinence symptoms (49% compared with 33%, P=.006) and treatment satisfaction (75% compared with 63%, P=.02). Combination therapy was significantly better than pessary as shown on the Patient Global Impression of Improvement (53%, P=.02) and Pelvic Floor Distress Inventory (44%, P=.05) but not better than behavioral therapy; it was therefore not superior to single-modality therapy. Group differences were not sustained to 12 months on any measure, and patient satisfaction remained above 50% for all treatment groups.
CONCLUSION
Behavioral therapy resulted in greater patient satisfaction and fewer bothersome incontinence symptoms than pessary at 3 months, but differences did not persist to 12 months. Combination therapy was not superior to single-modality therapy.
CLINICAL TRIAL REGISTRATION
ClinicalTrials.gov, www.clinicaltrials.gov, NCT00270998.
目的
比较阴道子宫托与基于证据的行为疗法治疗压力性尿失禁的效果，并评估阴道子宫托联合行为疗法是否优于单一模式疗法。
方法
这是一项多中心、随机临床试验（压力性尿失禁相关漏液的门诊治疗[ATLAS]），将 446 例压力性尿失禁女性随机分为阴道子宫托组、行为疗法组或联合治疗组。主要结局指标为 3 个月时的患者总体改善印象和盆底窘迫量表的压力性尿失禁亚量表。根据预先设定，要被认为具有临床优势，联合治疗必须优于两种单一模式治疗。在 6 个月和 12 个月时重复进行了测量。主要分析采用意向治疗方法。
结果
在 3 个月时，阴道子宫托组和行为组分别有 40%和 49%的患者在患者总体改善印象量表上的评分是“明显改善”或“非常明显改善”（P=.10）。与阴道子宫托组相比，更多的行为组患者报告没有困扰性的尿失禁症状（49%对比 33%，P=.006）和治疗满意度（75%对比 63%，P=.02）。组合治疗在患者总体改善印象（53%，P=.02）和盆底窘迫量表（44%，P=.05）上明显优于阴道子宫托治疗，但并不优于行为治疗；因此，组合治疗并不优于单一模式治疗。在任何测量指标上，组间差异在 12 个月时都没有持续存在，并且所有治疗组的患者满意度仍然保持在 50%以上。
结论
在 3 个月时，行为疗法比阴道子宫托治疗能带来更高的患者满意度和更少的困扰性尿失禁症状，但这些差异在 12 个月时并未持续存在。组合治疗并不优于单一模式治疗。
临床试验注册
ClinicalTrials.gov，www.clinicaltrials.gov，NCT00270998。
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