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

NCT07542080 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2026-05-05

No results posted yet for this study

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.

Conditions

  • Stress Incontinence Female
  • Urodynamic Exam
  • Urodynamic Stress Incontinence

Interventions

DIAGNOSTIC_TEST

urodynamic testing

The standard urodynamic studies (UDS, without X-rays) are performed in an outpatient setting by a doctor, clinical scientist or nurse.

DIAGNOSTIC_TEST

videourodynamic 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 & Collaborators

  • University College, London

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
100 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-10-06
Primary Completion
2027-06-06
Completion
2027-06-06

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07542080 on ClinicalTrials.gov