Vaginal Pessary in Women With Symptomatic Pelvic Organ Prolapse A Randomized Controlled Trial

Vaginal Pessary in Women With Symptomatic Pelvic Organ Prolapse A Randomized Controlled Trial
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DOI:
10.1097/aog.0000000000001489
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发表时间:
2016-07-01
影响因子:
7.2
通讯作者:
Chan, Symphorosa S. C.
Chan, Symphorosa S. C.
中科院分区:
医学2区
文献类型:
--
作者:
Cheung, Rachel Y. K.;Lee, Jacqueline H. S.;Chan, Symphorosa S. C.

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目的:比较有或没有阴道托具的盆腔器官脱垂(POP)患者的盆底症状、生活质量和并发症,以及进行盆底锻炼12个月的患者。方法:这是一项平行组、单盲、随机对照试验,随访12个月。有症状的I至III期POP的女性被随机分为盆底运动训练组(对照组)或盆底运动训练并插入阴道托组(阴道托组)。主要结局是通过盆底窘迫量表和盆底影响问卷来观察脱垂症状和生活质量的变化。次要结果包括脱垂症状的困扰、期望的治疗和任何并发症。结果:从2011年12月到2014年11月,311名女性被筛选,276名随机分组如下:对照组137名,子宫托组139名。子宫托组的132名(95.0%)妇女和对照组的128名(93.4%)妇女完成了研究。12个月后,两组盆腔器官脱垂困扰量表(盆底困扰量表)和盆腔器官脱垂影响问卷(盆底影响问卷)得分均下降,但盆腔器官脱垂困扰量表的平均得分差异较大(盆腔器官脱垂困扰量表:-29.7比-4.7,P
OBJECTIVE: To compare pelvic floor symptoms, quality of life, and complications in women with symptomatic pelvic organ prolapse (POP) with or without vaginal pessaries in addition to those who do pelvic floor exercises for 12 months.METHODS: This was a parallel-group, single-blind, randomized controlled trial with 12 months of follow-up. Women with symptomatic stage I to stage III POP were randomized to either pelvic floor exercises training (control group) or pelvic floor exercises training and insertion of a vaginal pessary (pessary group). The primary outcome was the change of prolapse symptoms and quality of life by using the Pelvic Floor Distress Inventory and Pelvic Floor Impact Questionnaires. Secondary outcomes included bothersome of prolapse symptoms, desired treatment, and any complications.RESULTS: From December 2011 through November 2014, 311 women were screened and 276 were randomized as follows: 137 to the control and 139 to the pessary group. One hundred thirty-two (95.0%) women in the pessary group and 128 (93.4%) in the control group completed the study. The Pelvic Organ Prolapse Distress Inventory of Pelvic Floor Distress Inventory and the Pelvic Organ Prolapse Impact Questionnaire of Pelvic Floor Impact Questionnaire scores decreased in both groups after 12 months, but the mean score differences were higher in the pessary group (Pelvic Organ Prolapse Distress Inventory: -29.7 compared with -4.7, P