Impact of CMG vs VCMG in recurrent stress incontinence- A Pilot Study
Research type
Research Study
Full title
Impact of urodynamic and video-urodynamic testing on surgical outcomes in women with recurrent urinary incontinence - A feasibility study
IRAS ID
264457
Contact name
Tamsin Greenwell
Contact email
Sponsor organisation
University College London
Clinicaltrials.gov Identifier
to be confirmed, https://findastudy.uclh.nhs.uk/
Duration of Study in the UK
1 years, 7 months, 1 days
Research summary
Main research aim:
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.Background:
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 non- validated.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, Reconstructive and Adolescent (FRA) Urology Service at UCLH adhering to standardised protocols. Treatment will be provided by FRA Team at UCLH.
Baseline patient reported outcome measures, 24h pads weights and flow charts will be compared with assessments at 3 and 6 months after incontinence surgery. 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.
REC name
London - Dulwich Research Ethics Committee
REC reference
24/LO/0444
Date of REC Opinion
7 Aug 2024
REC opinion
Further Information Favourable Opinion