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 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 115
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
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.
研究者
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