Clinical Trial of Patient Operated Valved Catheter Compared With Standard Indwelling Transurethral Catheter for Postoperative Bladder Management
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 49
- 主要终点
- Total Catheter Related Pain
研究概览
简要总结
Following surgery for female urinary incontinence and/or pelvic organ prolapse, women are sometimes temporarily unable to empty their bladders and are sent home with a transurethral indwelling catheter attached to a bag which holds urine. The goal of this study is to compare a new type of patient-operated catheter without a bag to the catheter with a bag for ease of use, comfort and quality of life for patients during the postoperative recovery period. This new catheter, the OPTION-vf, is approved by the FDA and is available on the market.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •patients undergoing surgery for urinary incontinence and/or pelvic organ prolapse at the UMass Memorial Medical Center with one of the Urogynecology/Reconstructive Pelvic Surgery faculty.
排除标准
- •inability to provide consent
- •<18 years old
- •non-English speaking
- •patients using intermittent self-catheterization
- •patients sustaining bladder injury during surgery
- •prisoners
- •pregnant women
研究组 & 干预措施
OPTION-vf patient controlled catheter
Patients who fail postop bladder challenge and are randomized to "OPTION-vf" arm will be instructed in the use and care of this catheter, discharged home with it in place and given an appointment between 5-10 days postop for a bladder challenge.
干预措施: Bladder catheter: OPTION-vf patient controlled catheter vs. indwelling transurethral catheter with leg bag (Device)
Transurethral catheter w/leg bag
Patients who fail postop bladder challenge and are randomized to "indwelling catheter with leg bag" arm will be instructed in the use and care of this catheter, discharged home with it in place and given an appointment between 5-10 days postop for a bladder challenge.
干预措施: Transurethral catheter with leg bag (Device)
结局指标
主要结局
Total Catheter Related Pain
时间窗: 5-10 days postoperatively
Total Catheter Related Pain Range Scale (0 = none, to 10 = worst) on the Post Operative Questionnaire All subjects were given and appointment for an outpatient voiding trial after hospital discharge. The Post Operative questionnaire was completed by the subject one time at that appointment.
次要结局
- Composite Satisfaction Score (CSS)(5-10 days postoperatively)
研究者
Michael Flynn
Principal Investigator
University of Massachusetts, Worcester