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临床试验/NCT02443987
NCT02443987已完成不适用

Time Interval Between TVT and First Void (TIBT) Study

Gloucestershire Hospitals NHS Foundation Trust2 个研究点 分布在 1 个国家目标入组 43 人开始时间: 2015年8月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
43
试验地点
2
主要终点
Time Interval Between End of Surgery and First Void

研究概览

简要总结

The primary aim of this study is to compare, in women undergoing tension-free vaginal tape (TVT) insertion under sedation and local anaesthetic infiltration, the time interval of first void following surgery between a group of patients who received intravenous fluids to those who did not.

详细描述

Urinary incontinence is a global condition and its prevalence increases with age. It impairs quality of life of patients and has a significant burden on the health care system. Stress urinary incontinence (SUI) is defined as involuntary leakage of urine when there is an increase in pressure on the bladder, i.e. during exercise, coughing or sneezing. It is the commonest form of urinary incontinence and affects around 50% of women with symptoms of incontinence.

The development of mid urethral tapes (e.g. the tension free vaginal tape [TVT]) in 1998 has greatly changed clinical practice. The introduction of TVTs has reduced the average length of hospital stay for patients undergoing surgical treatment of SUI by over 50%. As a result, the hospital bed occupancy for the treatment of SUI has decreased by a similar amount. Studies have shown it to have similar effectiveness to the main alternative surgical treatments in SUI.

In Gloucestershire Royal Hospital, we perform the procedure as a daycase with local anaesthetic infiltration under sedation. Routine cystoscopy is performed as a part of the procedure to exclude bladder trauma. The bladder is emptied at the end of procedure. Patients are then allowed to drink as normal and post void residuals are checked before discharge to rule out any problems emptying the bladder. It has been observed that the major limiting factor in early discharge of patients is the time to first void following surgery. As the patients are starved for surgery, they are often dehydrated and therefore require enough oral fluids to rehydrate and fill their bladder in order to void. If we can somehow reduce this waiting period, we can discharge patients sooner improving their experience with the surgery. We would like to examine whether filling up the bladder intra-operatively with intravenous fluid will reduce this time limiting step.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Triple (Participant, Care Provider, Investigator)

入排标准

年龄范围
18 Years 至 90 Years(Adult, Older Adult)
性别
Female
接受健康志愿者
是

入选标准

  • •Participant is willing and able to give informed consent for participation in the study

排除标准

  • •TVT performed under general or spinal anaesthetic
  • •Women under the age of 18 years
  • •Women unable to give informed consent
  • •TVT performed in addition to another procedure
  • •Women not suitable for a fluid challenge due to co-morbidities.

研究组 & 干预措施

Received intravenous fluids

Experimental

The patient will receive 500ml of 0.9% NaCl fluid intravenously during the operation.

干预措施: Intravenous fluid (Other)

Control Arm

No Intervention

The patient will receive no intravenous fluid as per current routine protocol

结局指标

主要结局

Time Interval Between End of Surgery and First Void

时间窗: The participants will be followed for the duration of hospital stay, which is expected to be an average of 6 hours (and no longer than 24 hours)

次要结局

  • Volume of Urine Passed(The participants will be followed for the duration of hospital stay, which is expected to be an average of 6 hours (and no longer than 24 hours))
  • Residual Volume in Bladder(The participants will be followed for the duration of hospital stay, which is expected to be an average of 6 hours (and no longer than 24 hours))
  • Time to "Fit for Discharge"(The participants will be followed for the duration of hospital stay, which is expected to be an average of 6 hours (and no longer than 24 hours))
  • Number of Patient's Requiring In-out Catheterisation Due to Difficulty Voiding(The participants will be followed for the duration of hospital stay, which is expected to be an average of 6 hours (and no longer than 24 hours))
  • Patient Satisfaction Using Patient Questionnaire(The participants will be followed for the duration of hospital stay, which is expected to be an average of 6 hours (and no longer than 24 hours))

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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