跳至主要内容
临床试验/jRCT1062240037
jRCT1062240037进行中(未招募)不适用

A single-blind, randomised, controlled trial evaluating the efficacy of an open-ended urinary catheter for catheter-related bladder discomfort after urologic surgery.

未提供0 个研究点目标入组 100 人开始时间: 2024年8月16日最近更新:

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
100
主要终点
-

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional
分配方式
Randomized Controlled Trial
干预模型
Parallel Assignment
主要目的
Treatment Purpose
盲法
Single Blind

入排标准

年龄范围
18age 0month old over 至 No limit(—)
性别
All

入选标准

  • Patients aged 18 years and over at the time of obtaining consent.
  • Patients with non muscle invasive bladder cancer, renal cell carcinoma, or upper truct urothelial cancer (renal pelvis or ureter) who will undergo transurethral resection, radical nephroureterectomy, partial nephrectomy or radical nephrectomy with postoperative bladder urinary catheter placement.
  • Patients for whom written consent to participate in the study is obtained from the individual.

排除标准

  • Patients who already have a urinary catheter in place before urologic surgery or who are on CIC (clean intermittent catheterization).
  • Patients with spinal cord paralysis or sensory insensitivity below the thoracic spinal cord.
  • Patients scheduled for epidural anaesthesia for post-operative analgesia.
  • Patients with a diagnosis of dementia.
  • Patients on maintenance haemodialysis.
  • Patients with preoperative uncontrolled urinary tract infections.
  • Patients with a history of previous pelvic radiotherapy.
  • Patients with urethral injuries.
  • Patients with allergic symptoms or history of allergy to natural rubber latex.
  • Other patients deemed unsuitable by the principal investigator or a sub-investigator.

结局指标

主要结局

-

Percentage of CRBDs at 6 hours post-operatively

次要结局

  • Percentage and severity of CRBD(0, 1, 3 and 6 hours postoperatively, plus 24, 48 and 72 hours during catheterisation after 6 hours and up to 72 hours after removal of the catheter during catheterisation. Catheters were left in place for a minimum of 6 hours and removed at any time thereafter.)
  • Urethral pain scale(0, 1, 3 and 6 hours postoperatively, plus 24, 48 and 72 hours during catheterisation after 6 hours and up to 72 hours after removal of the catheter during catheterisation. Catheters were left in place for a minimum of 6 hours and removed at any time thereafter.)
  • Type of drug therapy for CRBD, number of times used
  • Percentage of adverse events

研究者

发起方
未提供

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