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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

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

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07643454
Acronym
Mini-DUCC
Enrollment
80
Registered
2026-06-11
Start date
2026-09-01
Completion date
2027-01-01
Last updated
2026-07-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bladder Calculi, Continent Catheterizable Urinary Reservoir, Open Cystolithotomy, Trans-Stomal Bladder Lithotripsy

Brief 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.

Interventions

OTHERQoL-DUCC questionnaire

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

OTHERQualiveen Questionnaire

Patients of all groups will answer this validated quality of life questionnaire

Sponsors

Hospices Civils de Lyon
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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)

Design outcomes

Primary

MeasureTime frameDescription
Residual stone size greater than 4mm postoperatively.Up to 7 days after surgeryResidual stone size greater than 4mm postoperatively will be investigated on imaging control

Secondary

MeasureTime frameDescription
Qol-DUCC questionnaire answersAt inclusionanswers to the Qol-DUCC questionnaire will be analysed to assess patient quality of life
Qualiveen questionnaire scoreAt inclusionThe Qualiveen questionnaire score will be analysed to assess patient quality of life, for individuals who have urinary disorders. It contains 4 domains: Limitations/Inconvenience, Constraints/Restrictions, Fears, Feelings/Impact on Daily Life. The questionnaire is based on a 5-point Likert scale (0 = "not at all", 4 = "extremely"). Each domain score is calculated as an average of the scores for the domain items. An overall (averaged) score can also be calculated. Lower scores on this questionnaire indicate higher quality of life.

Countries

France

Contacts

CONTACTNadia ABID, MD, PhD
nadia.abid@chu-lyon.fr+33 4 72 11 96 75
CONTACTLéonard TOTARO, MD
leonard.totaro@chu-lyon.fr+33 613230009
PRINCIPAL_INVESTIGATORNadia ABID, MD, PhD

Hospices Civils de Lyon

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 2, 2026