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

Sponsor: University College, London

NCT ID: NCT07542080

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Access to the study treatment being tested
Type of study
Interventional (receives a drug or procedure)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
urodynamic testing (diagnostic test), videourodynamic testing (diagnostic test)
How long the study runs
Study runs about 20 months (dates as stated)
About the drug or intervention
urodynamic testing — diagnostic test: The standard urodynamic studies (UDS, without X-rays) are performed in an outpatient setting by a doctor, clinical scientist or nurse. · videourodynamic testing — diagnostic test: 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.
Patient visit burden
Not specified by the sponsor
Type of study
Testing a treatment
Ages
18 Years to 100 Years
Who
Female
Number of participants
30
Started
2025-10-06
Last checked
2026-04

Plain English Summary

What is this study?

  • • Testing a new treatment for stress incontinence female
  • • NA - 30 participants
  • • 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

Who can take part?

  • • Ages 18 Years to 100 Years
  • • Diagnosed with stress incontinence female
  • • Female only

Where?

  • • London - University College Hospital at Westmoreland Street

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

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.

Stress Incontinence FemaleUrodynamic ExamUrodynamic Stress Incontinence

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Eligibility at a Glance

Key info

  • Age: 18 Years - 100 Years
  • Who can join: Female only

What the study is looking for

  • ✓competent (able to consent)
  • ✓adult women (over 18 years old)
  • ✓with recurrent stress urinary incontinence

Who cannot take part

  • ✗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
See the full criteria
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

Where Is This Study? (1 UK site)

University College Hospital at Westmoreland Street

London W1G 8PH, United Kingdom

Recruiting
Site contact (verified)
Bogdan Toia, MD (Romania)+447864707846bogdan.toia1@nhs.net
Tamsin J Greenwelltamsin.greenwell2@nhs.net

How to Get in Touch

Bogdan Toia, MD (Romania)

Sponsor contact

CONTACT

+447864707846 bogdan.toia1@nhs.net
Data sourced from ClinicalTrials.gov · Last verified: 2026-04