Impact of Urodynamic and Video-urodynamic Testing on Surgical Outcomes in Women With Recurrent Urinary Incontinence - A Feasibility Study
Overview
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- University College, London
- 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
Intervention: urodynamic testing (Diagnostic Test)
videourodynamic testing
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