Actively Recruiting

Phase Not Applicable
Age: 18Years - 100Years
FEMALE
NCT07542080

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

Led by University College, London · Updated on 2026-05-05

30

Participants Needed

1

Research Sites

86 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years - 100Years
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Able to give informed consent
  • Adult women aged over 18 years
  • Have recurrent stress urinary incontinence
Not Eligible

You will not qualify if you...

  • Currently pregnant
  • Unfit for surgery
  • Body mass index (BMI) over 35
  • History of pelvic radiotherapy or neurogenic disease risking neurogenic bladder

AI-Screening

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Trial Site Locations

Total: 1 location

1

University College Hospital at Westmoreland Street

London, United Kingdom, W1G 8PH

Actively Recruiting

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Research Team

B

Bogdan Toia, MD (Romania)

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

DIAGNOSTIC

Number of Arms

2

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