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Clinical Trials/NCT07542080
NCT07542080
Recruiting
Not Applicable

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

University College, London1 site in 1 country30 target enrollmentStarted: October 6, 2025Last updated:

Overview

Phase
Not Applicable
Status
Recruiting
Enrollment
30
Locations
1
Primary Endpoint
Primary outcome

Overview

Brief 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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Diagnostic
Masking
None

Eligibility Criteria

Ages
18 Years to 100 Years (Adult, Older Adult)
Sex
Female
Accepts Healthy Volunteers
No

Inclusion Criteria

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

Exclusion Criteria

  • Women who are pregnant, unfit for surgery, BMI over 35, background of pelvic radiotherapy or relevant neurogenic disease that would put them at risk of neurogenic bladder will be excluded.

Arms & Interventions

urodynamic testing

Experimental

Intervention: urodynamic testing (Diagnostic Test)

videourodynamic testing

Active Comparator

Intervention: videourodynamic testing (Diagnostic Test)

Outcomes

Primary Outcomes

Primary outcome

Time Frame: 6 months

To explore whether urodynamic or video-urodynamic investigations improve continence at 6 months post intervention. Outcomes will be measured using patient reported outcome of continence at 6 months post-surgical intervention

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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