Stress Incontinence Female, Urodynamic Exam, Urodynamic Stress Incontinence
Conditions
Keywords
urodynamics, videourodynamics, stress incontinence
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. 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.
Interventions
DIAGNOSTIC_TESTurodynamic testing
The standard urodynamic studies (UDS, without X-rays) are performed in an outpatient setting by a doctor, clinical scientist or nurse.
DIAGNOSTIC_TESTvideourodynamic 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.
Sponsors
University College, London
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 100 Years
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 * body mass index (BMI) over 35 * background of pelvic radiotherapy or relevant neurogenic disease that would put them at risk of neurogenic bladder
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary outcome | 6 months | To explore whether urodynamic or video-urodynamic investigations improve continence at 6 months post intervention. Outcomes will be measured using Patient Global Impression of Improvement (PGI-I) |
Countries
United Kingdom
Contacts
CONTACTBogdan Toia, MD (Romania)
Outcome results
None listed