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临床试验/NCT07542080
NCT07542080招募中不适用

Impact of Urodynamic and Video-urodynamic Testing on Surgical Outcomes in Women With Recurrent Urinary Incontinence

University College, London1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2025年10月6日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
30
试验地点
1
主要终点
Primary outcome

研究概览

简要总结

To asses feasibility of a prospective randomised trial comparing the outcomes of surgery for recurrent urinary incontinence after video-urodynamic(VCMG)and urodynamic(UDS)investigations. One of the greatest challenges for clinicians is the lack of correlation between bothersome urinary symptoms and the underlying urinary tract dysfunction. This has led to the development of several investigations aimed at improving diagnostic accuracy, with UDS and VUDS being the most noteworthy. Despite the heavy reliance on these invasive tests by clinicians, their indications and efficacy remain controversial and supporting literature data is scarce and nonvalidated. The investigators will perform a prospective randomised study of 30 women referred to our tertiary urological services at University College London Hospitals (UCLH) for treatment of recurrent stress urinary incontinence. The women will be investigated with either UDS or VUDS prior to receiving medical and surgical treatment tailored to the identified underlying urinary tract dysfunction. Adult women with symptoms suggestive of recurrent stress urinary incontinence after failed continence surgery will be included. Women who are pregnant, unfit for surgery, have a background of pelvic radiotherapy or relevant neurogenic disease that would put them at risk of neurogenic bladder will be excluded. UDS/VUDS will be performed under the care of Functional, Reconstructive and Adolescent Urology (FFA) Urology Service at UCLH adhering to standardised protocols. Treatment will be provided by FRA Team at UCLH. The primary outcome is assessment of symptoms of urinary incontinence by using validated questionnaires. Results will be correlated with patient characteristics, X-ray exposure, patient experience metrics, outcome and expenses to determine in which sub-populations performing UDS or VUDS has a higher impact on outcomes and when they should be avoided.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
18 Years 至 100 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • competent (able to consent)
  • adult women (over 18 years old)
  • with recurrent stress urinary incontinence

排除标准

  • women who are pregnant
  • unfit for surgery
  • body mass index (BMI) over 35
  • background of pelvic radiotherapy or relevant neurogenic disease that would put them at risk of neurogenic bladder

研究组 & 干预措施

urodynamic testing

Experimental

干预措施: urodynamic testing (Diagnostic Test)

videourodynamic testing

Active Comparator

干预措施: videourodynamic testing (Diagnostic Test)

结局指标

主要结局

Primary outcome

时间窗: 6 months

To explore whether urodynamic or video-urodynamic investigations improve continence at 6 months post intervention. Outcomes will be measured using Patient Global Impression of Improvement (PGI-I)

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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