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临床试验/NCT03937531
NCT03937531撤回不适用

Comparison of Postoperative Voiding Dysfunction in Two Voiding Trials After Retropubic Midurethral Slings: a Randomized Controlled Trial

Icahn School of Medicine at Mount Sinai2 个研究点 分布在 1 个国家开始时间: 2020年2月最近更新:
适应症

试验速览

阶段
不适用
状态
撤回
试验地点
2
主要终点
Void trial failure rates

研究概览

简要总结

The primary objective of this project is to compare the rate of postoperative voiding dysfunction in two voiding trials (the retrograde-fill technique versus the spontaneous-fill technique) after midurethral sling (MUS) procedures with tension-free vaginal tape (TVT) without any concomitant surgery.

详细描述

The purpose of this research study is that the study investigators want to find out if there is a way of reducing patients' postoperative emotional stress from having a separate procedure to test their urinary function after "sling" surgery. Women with stress urinary incontinence (leakage of urine with physical activities like coughing, jumping, running, laughing, etc) may need "sling" surgery to help their urinary leakage problems. "Sling" surgeries in our hospital are mainly done using a retropubic midurethral sling (sling is passed to the space in front of your bladder). It is well known that having a sling surgery dramatically helps women with stress urinary incontinence. However, any surgical managements can have complications. One of the common complications from having a sling is "postoperative voiding dysfunction". In other words, some women may have a problem with urinating normally after the sling surgery. The most common problem is that some women (up to 4 out of 10 women) may not be able to urinate right after the surgery for the brief period of the time. The study team calls this condition "urinary retention". Postoperative urinary retention after the sling surgery can occur mainly due to pain, anesthesia effect, underlying tissue swelling; and rarely secondary to bleeding or nerve damage. Not being able to urinate for long time (>6-8 hours) can damage the bladder muscle and nerves to the bladder. Therefore, most surgeons like to perform a "bladder testing" in the recovery unit before you are ready to go home to make sure you would be able to urinate at home once discharged. Traditionally, the bladder testing is involved with back-filling the bladder with sterile water (about 300cc) and checking if the patients are able to urinate within 30 minutes. The patients should be able to urinate about two thirds of amount that has been placed in the bladder. This "bladder testing" can create a lot of emotional stress to the patients; consequently, some of the patients may not be able to urinate within the given time although there is nothing wrong with their bladder function. Those patients, who did not pass this testing, are sent home with an indwelling urinary catheter with legbag until they come back to clinic for another "bladder testing" in 3-7 days. It is well known that the indwelling catheters are a leading cause of urinary tract infection and a source of patients' discomfort, embarrassment, and inconvenience. Therefore, this study is designed to find out if having a bladder test after the sling surgery is a really-must thing to perform to test the bladder function. The study team would like to investigate if allowing the patients to have enough time to urinate their own, without making them to go through the bladder testing, would be a sufficient way of testing the bladder function after sling surgery.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
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

入选标准

  • Any adult female (age >= 18 years old) undergoing an outpatient TVT surgery for SUI will be eligible for participation.
  • Participants must be able to provide informed consent and complete all study requirements.

排除标准

  • Participants will be excluded if the surgery involves any concomitant urinary tract or pelvic reconstructive procedure or if the procedure, in itself, necessitates PUC, as in the event of a cystotomy, bladder perforation or intraoperative hemorrhage
  • Participants with a history of neurologic conditions affecting the urinary tract system, POP beyond the hymen during straining (any compartment), or previous anti-incontinence procedure will be also excluded.

结局指标

主要结局

Void trial failure rates

时间窗: Day of surgery

The void trial failure rates requiring postoperative urinary catheterization after midurethral sling procedures with transvaginal tape (TVT) without concomitant surgery. First, the bladder will be completely drained into the Foley bag then the bag will be detached from the catheter. The bladder will be back-filled with sterile water (300 mL). After the catheter is removed, subjects are expected to void at least 2/3 (200 mL) of the total instilled amount within 30 minutes of filling. PVR will be measured by both subtraction of the voided volume from 300cc and by using a bladder scanner.

次要结局

  • Number of participants with Postoperative urinary retention (POUR)(2 weeks and 6 weeks post surgery)
  • Time to discharge(On the day of surgery)
  • Number of participants with Urinary tract infection(Within 6 weeks after surgery)
  • Incontinence Severity Index (ISI)(2 weeks and 6 weeks post surgery)
  • Urogenital Distress Inventory short form (UDI-6)(2 weeks and 6 weeks post surgery)
  • Patient Global Impression of Improvement (PGI-I)(2 weeks and 6 weeks post surgery)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Woojin Chong-Kaufman

Assistant Professor & Assistant FPMRS Program Director

Icahn School of Medicine at Mount Sinai

研究点 (2)

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