Safety and effectiveness of Colpexin Sphere in the treatment of pelvic organ prolapse
Safety and effectiveness of Colpexin Sphere in the treatment of pelvic organ prolapse
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DOI：
10.1007/s00192-005-0033-2
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发表时间：
2006-10-01
影响因子：
1.8
通讯作者：
Sand, Peter K.
中科院分区：
文献类型：
--
作者：
Lukban, James Chivian;Aguirre, Oscar A.;Sand, Peter K.
我们的目的是确定Colpexin Sphere在晚期生殖器脱垂妇女中的安全性和有效性。我们的前瞻性多中心临床试验共纳入39名受试者，其中27人完成了完整的16周评估。在基线，受试者配备了一个球体，指导插入和取出，并接受骨盆底肌肉锻炼方案的教育。通过基线与16周比较盆腔器官脱垂分期和盆底肌力评估来评估疗效。安全性评估包括但不限于阴道粘膜完整性评估。在研究结束时，受试者还完成了一份患者满意度问卷。81.5%的受试者至少有一个阴道段脱垂得到改善，而63%的受试者在16周的指检中表现出肌肉功能的改善。25人（92.6%）会推荐该装置治疗脱垂，大多数人认为该装置易于插入（96.3%）和取出（100%）。在短期使用中，排尿（29.6%）和排便（72%）出现问题，主要是由于器械移位。两名受试者出现阴道粘膜浅表性溃疡，并自行消退。无明显不良事件报道。
Our objective was to determine the safety and effectiveness of Colpexin Sphere in women with advanced genital prolapse. A total of 39 subjects were enrolled in our prospective multicenter clinical trial, and 27 completed the full 16-week assessment. At baseline, subjects were fitted with a sphere, instructed on insertion and removal, and educated on a regimen of pelvic floor muscle exercises performed with the device in place. Efficacy was evaluated by a baseline vs 16-week comparison of pelvic organ prolapse staging and pelvic floor muscle strength assessment. Safety evaluation included, but was not limited to, an assessment of vaginal mucosal integrity. Subjects also completed a patient satisfaction questionnaire at the end of the study. Improvement in the prolapse of at least one vaginal segment was seen in 81.5% of the subjects, while 63% exhibited improved muscle function on digital examination at 16 weeks. Twenty-five (92.6%) would recommend the device to treat prolapse, and most found it easy to insert (96.3%) and remove (100%). In short-term usage, problems with urination (29.6%) and defecation (72%) were reported, primarily due to device displacement. Two subjects developed superficial vaginal mucosal ulceration, which resolved spontaneously. No significant adverse events were reported.