Impact of CMG vs VCMG in Recurrent Stress Incontinence- A Pilot Study

Официальное название

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

Обзор

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.

Вмешательства

• Диагностический тест urodynamic testing
  The standard urodynamic studies (UDS, without X-rays) are performed in an outpatient setting by a doctor, clinical scientist or nurse.
• Диагностический тест videourodynamic testing
  Video-urodynamic studies (VUDS) can only be performed in a radiology department by a doctor, clinical scientist or nurse with specific X-ray training in the presence of a radiographer.

Первичные конечные точки

• Primary outcome [Срок оценки: 6 months]

Критерии участия

Критерии включения

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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Диагностика

Центры проведения

Великобритания · 1 центр

• University College Hospital at Westmoreland Street — London

Идентификаторы

NCT: NCT07542080 · 264457

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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