NL-OMON30439
已完成
不适用
A randomised controlled trial comparing the clinical and cost-effectiveness of the Avaulta anterior mesh and the standard anterior colporraphy for the primary surgical treatment of a cystocele stage >= 2 - Avaulta versus anterior colphorraphy
niversitair Medisch Centrum Utrecht0 个研究点目标入组 115 人待定
概览
- 阶段
- 不适用
- 干预措施
- 未指定
- 疾病 / 适应症
- cystocele
- 发起方
- niversitair Medisch Centrum Utrecht
- 入组人数
- 115
- 状态
- 已完成
- 最后更新
- 去年
概览
简要总结
暂无简介。
研究者
入排标准
入选标准
- •Women aged 40\-80 years
- •Cystocele stage \>\= 2 according to POP Q classification
- •No previous anterior colporraphy
- •Good understanding of Dutch language in word en writing
排除标准
- •1\. Women with childbearing potential who do not use adequate contraceptive measures (hormonal contraceptives, barrier methods (condoms), intra uterine device, male vasectomy, sterilisation).
- •2\. History of major gynaecological or urological surgery, with the exception of a hysterectomy for reasons other than a genital prolapse.
- •3\. History of cancer or severe cardiopulmonary disease
- •4\. Conditions that might interfere with a successful conduction and completion of the study in the opinion of the specialist (language problems, cognitive dysfunction, etc)
- •5\. Recurrent lower urinary tract infections (\> 3 culture proven infections/year)
- •6\. Maximum bladder capacity \< 300 ml (bladder diary)
- •7\. Urinary stress incontinence with an indication for surgical correction.
结局指标
主要结局
未指定
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