ISRCTN97985616已完成不适用
A randomised controlled trial comparing the use of a urethral insert, (FemSoft®) with vaginal tampons in the management of female stress urinary incontinence
Rochester Medical Ltd (UK)0 个研究点目标入组 90 人开始时间: 2011年8月24日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 90
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
- 性别
- Female
入选标准
- •1. Female participants over 18 years of age
- •2. Not pregnant and if of child-bearing age agrees to use reliable contraception throughout the trial
- •3. Able and willing to use tampons
- •4. Sufficient mobility / dexterity to use device and competent mentally
- •5. Able to give consent
- •6. Confirmed moderate to severe (at least one episode per day on average) SUI or mixed incontinence that is SUI predominant (cough test or urodynamic assessment)
- •7. Period of trial representative of normal activities (e.g. does not include a holiday)
排除标准
- •1. Body mass index (BMI) > 40
- •2. Previous surgery for SUI
- •3. Pelvic organ prolapse (POP) > stage 2
- •4. Using medication to treat urinary incontinence such as anticholinergics or duloxetine
- •5. History of recurrent urinary tract infections or signs and symptoms of a urinary tract infection
- •6. Signs and symptoms of vaginal / urethral irritations
- •7. Post residual volumes greater than 200 ml
- •8. Unable to understand instructions for use of the device
研究者
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