The primary outcomes and power calculations in clinical RCTs in urogynecology - need for improvement?

泌尿妇科临床随机对照试验的主要结果和统计功效计算——是否需要改进?

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Abstract

OBJECTIVES: To develop and test a method for measuring the relationship between the rise in intra-abdominal pressure and sagittal plane movements of the anterior and posterior vaginal walls during Valsalva in a pilot sample of women with and without prolapse. METHODS: Mid-sagittal MRI images were obtained during Valsalva while changes in intra-abdominal pressure were measured via a bladder catheter in 5 women with cystocele, 5 women with rectocele, and 5 controls. The regional compliance of the anterior and posterior vagina wall support systems were estimated from the ratio of displacement (mm) of equidistant points along the anterior and posterior vaginal walls to intra-abdominal pressure rise (mmHg). RESULTS: The compliance of both anterior and posterior vaginal wall support systems varied along different regions of vaginal wall for all three groups, with the highest compliance found near the vaginal apex and the lowest near the introitus. Women with cystocele had more compliant anterior and posterior vaginal wall support systems than women with rectocele. The movement direction differs between cystocele and rectocele. In cystocele, the anterior vaginal wall moves mostly toward the vaginal orifice in the upper vagina, but in a ventral direction in the lower vagina. In rectocele, the direction of the posterior vaginal wall movement is generally toward the vaginal orifice. CONCLUSIONS: Movement of the vaginal wall and compliance of its support is quantifiable and was found to vary along the length of the vagina. Compliance was greatest in the upper vagina of all groups. Women with cystocele demonstrated the most compliant vaginal wall support.

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