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

NCT07542080 | Recruiting

• 1 other identifier: 264457
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Stress Incontinence Female; Urodynamic Exam; Urodynamic Stress Incontinence

Keywords

urodynamics; videourodynamics; stress incontinence

Outcome Measures

Primary Outcomes (1)

• Primary outcome

  To explore whether urodynamic or video-urodynamic investigations improve continence at 6 months post intervention. Outcomes will be measured using Patient Global Impression of Improvement (PGI-I)

  6 months

Study Arms (2)

urodynamic testing

EXPERIMENTAL

Diagnostic Test: urodynamic testing

videourodynamic testing

ACTIVE COMPARATOR

Diagnostic Test: videourodynamic testing

Interventions

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.

urodynamic testing

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.

videourodynamic testing

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University College, London: lead

Study Sites (1)

University College Hospital at Westmoreland Street

London, W1G 8PH, United Kingdom

RECRUITING

MeSH Terms

Conditions

Urinary Incontinence, Stress

Condition Hierarchy (Ancestors)

Urinary Incontinence; Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Bogdan Toia, MD (Romania)

CONTACT

+447864707846; bogdan.toia1@nhs.net

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 14, 2026
• First Posted: April 21, 2026
• Study Start: October 6, 2025
• Primary Completion (Estimated): June 6, 2027
• Study Completion (Estimated): June 6, 2027
• Last Updated: May 5, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)