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RECRUITING
NCT07542080
NA

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

Sponsor: University College, London

View on ClinicalTrials.gov

Summary

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. We will perform a prospective randomised study of 30 women referred to our tertiary urological services at 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 The Female, Functional and Restorative (FFR) Urology Service at UCLH adhering to standardised protocols. Treatment will be provided by FFR Team at UCLH. The primary outcome is assessment of symptoms of urinary incontinence by using validated questionnaires (PGII and ICIQ-UI-SF). 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.

Official title: Impact of Urodynamic and Video-urodynamic Testing on Surgical Outcomes in Women With Recurrent Urinary Incontinence - A Feasibility Study

Key Details

Gender

FEMALE

Age Range

18 Years - 100 Years

Study Type

INTERVENTIONAL

Enrollment

30

Start Date

2025-10-06

Completion Date

2027-06-06

Last Updated

2026-04-21

Healthy Volunteers

No

Interventions

DIAGNOSTIC_TEST

urodynamic testing

The standard urodynamic studies (UDS, without X-rays) are performed in an outpatient setting by a doctor, clinical scientist or nurse.

DIAGNOSTIC_TEST

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.

Locations (1)

University College Hospital at Westmoreland Street

London, United Kingdom