NCT07542080 Impact of CMG vs VCMG in Recurrent Stress Incontinence- A Pilot Study
| NCT ID | NCT07542080 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University College, London |
| Condition | Stress Incontinence Female |
| Study Type | INTERVENTIONAL |
| Enrollment | 30 participants |
| Start Date | 2025-10-06 |
| Primary Completion | 2027-06-06 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 30 participants in total. It began in 2025-10-06 with a primary completion date of 2027-06-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07542080 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 100 Years, studying Stress Incontinence Female. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07542080 currently recruiting?
Yes, NCT07542080 is actively recruiting participants. Contact the research team at bogdan.toia1@nhs.net for enrollment information.
Where is the NCT07542080 trial being conducted?
This trial is being conducted at London, United Kingdom.
Who is sponsoring the NCT07542080 clinical trial?
NCT07542080 is sponsored by University College, London. The trial plans to enroll 30 participants.