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Recruiting Observational

Comparison of Trans-Stomial Bladder Lithotripsy Using Mini-Percutaneous Equipment Versus Trans-stomial Bladder Lithotripsy Using Flexible Fibroscope, Percutaneous Approach and Open Cystolithotomy in Patients With Continent Catheterizable Urinary Reservoir

NCT07643454 · tracked via the Priya Life Science France tracker
Phase
Observational
Started
2026-10-19
Last updated
2026-10-26

Condition(s) studied

Bladder CalculiContinent Catheterizable Urinary ReservoirTrans-Stomal Bladder LithotripsyOpen Cystolithotomy

Investigational drug(s) / intervention(s)

QoL-DUCC questionnaireQualiveen Questionnaire

QoL-DUCC questionnaire: Patients of all groups will answer this quality of life questionnaire that has been specially designed for the study

Qualiveen Questionnaire: Patients of all groups will answer this validated quality of life questionnaire

Study summary

The urological management of neurological patients is crucial to ensure patient survival and improve their quality of life. The natural progression of disease in central neurological bladders typically involves a major decrease in both bladder capacity and contractile function, often necessitating cystectomy. One alternative to urinary reconstruction is continent catheterizable urinary diversion (e.g., Miami pouch, Mitrofanoff, Monti, etc.). A common complication of these diversions is the formation of intravesical stones, which require surgical management. When the urethra allows access to the urinary diversion, the gold standard is transurethral lithotripsy using a cystoscope; however, when this is not feasible, several techniques exist, albeit without clear recommendations.

In the literature, the most frequently discussed techniques include bladder dilation, percutaneous bladder lithotripsy using nephrolithotripsy (NLPC) equipment, and trans-stomal lithotripsy using a flexible fibroscope. Although bladder dilation has shown higher complication rates in case series compared to other techniques, there is very little comparative data between the percutaneous and trans-stomal methods in the literature. Case series indicate a higher risk of fistula formation with the percutaneous technique for urinary diversions performed in the gastrointestinal tract as compared to native bladder diversions, and a risk of stenosis or loss of continence with the trans-stomal technique.

At the Hospices Civils de Lyon (HCL), the Urology Department of the Lyon Sud Hospital has expertise in neuro-urology with a large cohort of patients presenting continent catheterizable urinary diversions, and the Urology Department of Edouard Herriot Hopspital has expertise in NLPC, particularly with the use of mini-NLPC (smaller nephroscope diameter). The synergy between these two departments has enabled the creation of a large cohort, with frequent use of the percutaneous route for bladder lithotripsy and, since 2020, the trans-stomal route using mini-NLPC equipment.

Therefore, given the limited data available in the literature, this retrospective comparative study would provide stronger evidence to improve the management of these patients.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Adult patient (aged 18 years or older) * Patient with a catheterizable continent urinary diversion * History of surgical intervention via vesicolithotomy, percutaneous cystolitholapaxy, trans-stomal cystolitholapaxy, or flexible endoscopic laser cystolithotripsy via the continent stoma between 01/01/2015 and 31/12/2024 * Patient has expressed non-opposition to participate in the research Exclusion Criteria: * Percutaneous or trans-stomal surgery for foreign body removal * Postoperative follow-up period of less than 1 month after lithotripsy (Except for Clavien-Dindo Grade V cases)

Primary outcome measure(s)

  • Residual stone size greater than 4mm postoperatively. — Up to 7 days after surgery
    Residual stone size greater than 4mm postoperatively will be investigated on imaging control

Trial sites (2)

FacilityCityRegionStatus
Hôpital Edouard Herriot Lyon France Recruiting
Hôpital Lyon Sud Pierre-Bénite France Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07643454 on ClinicalTrials.gov ↗ ← All trials in France