Language: BG BG
← Back to results
Recruiting Not applicable NCT07542080

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

No applicable phase (e.g. observational)
Conditions: Stress Incontinence Female Urodynamic Exam Urodynamic Stress Incontinence

Sponsor: University College, London

trial.available_in: БГ
Overview
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.
Who can participate
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.
Interventions
urodynamic testing
DIAGNOSTIC_TEST
videourodynamic testing
DIAGNOSTIC_TEST
Locations 1
United Kingdom (1)
University College Hospital at Westmoreland Street
London
Bogdan Toia, MD (Romania)
Technical details
Status
Recruiting
Phase
Not applicable
Study type
INTERVENTIONAL
Sex
Female only
Minimum age
18 Years
Maximum age
100 Years
Healthy volunteers
No
Start date
06.10.2025
Completion date
06.06.2027
Registry ID
NCT07542080
Source
clinicaltrials.gov
trial.inquiry_btn

Information is automatically extracted from ClinicalTrials.gov. Consult your doctor before taking action.