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 (Mini-DUCC)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Bladder Calculi; Continent Catheterizable Urinary Reservoir; Trans-Stomal Bladder Lithotripsy; Open Cystolithotomy
• Intervention / Treatment: Other: QoL-DUCC questionnaire; Other: Qualiveen Questionnaire

• Study Type: Observational
• Enrollment (Estimated): 80

Contacts and Locations

• Study Contact: Name: Nadia ABID, MD, PhD; Phone Number: +33 4 72 11 96 75; Email: nadia.abid@chu-lyon.fr
• Study Contact Backup: Name: Léonard TOTARO, MD; Phone Number: +33 613230009; Email: leonard.totaro@chu-lyon.fr

Study Locations

• France
  • Lyon, France, 69003
    • Hôpital Edouard Herriot
    • Contact: Nadia ABID, MD, PhD; Phone Number: +33 4 72 11 96 75; Email: nadia.abid@chu-lyon.fr
  • Pierre-Bénite, France, 69495
    • Hôpital Lyon Sud
    • Contact: Théo ARBER, MD, PhD; Phone Number: +33 472678813; Email: theo.arber@chu-lyon.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Major patients with a continent cutaneous urinary diversion, followed in the urology departments of Lyon Sud Hospital and Édouard Herriot Hospital

Description

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)

Study Plan

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Trans-Stomal Bladder Lithotripsy Using Mini-Percutaneous Equipment; Patient operated on using Trans-Stomal Bladder Lithotripsy Using Mini-Percutaneous Equipment	Other: QoL-DUCC questionnaire; Patients of all groups will answer this quality of life questionnaire that has been specially designed for the study; Other: Qualiveen Questionnaire; Patients of all groups will answer this validated quality of life questionnaire
Trans-stomial bladder lithotripsy using flexible fibroscope; Patient operated on using Trans-stomial bladder lithotripsy using flexible fibroscope	Other: QoL-DUCC questionnaire; Patients of all groups will answer this quality of life questionnaire that has been specially designed for the study; Other: Qualiveen Questionnaire; Patients of all groups will answer this validated quality of life questionnaire
Percutaneous cystholithotripsy; Patient operated on using Percutaneous cystholithotripsy	Other: QoL-DUCC questionnaire; Patients of all groups will answer this quality of life questionnaire that has been specially designed for the study; Other: Qualiveen Questionnaire; Patients of all groups will answer this validated quality of life questionnaire
Open Cystolithotomy; Patient operated on using Open Cystolithotomy	Other: QoL-DUCC questionnaire; Patients of all groups will answer this quality of life questionnaire that has been specially designed for the study; Other: Qualiveen Questionnaire; Patients of all groups will answer this validated quality of life questionnaire

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Residual stone size greater than 4mm postoperatively.	Residual stone size greater than 4mm postoperatively will be investigated on imaging control	Up to 7 days after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Qol-DUCC questionnaire answers	answers to the Qol-DUCC questionnaire will be analysed to assess patient quality of life	At inclusion
Qualiveen questionnaire score	The Qualiveen questionnaire score will be analysed to assess patient quality of life	At inclusion

Collaborators and Investigators

• Sponsor: Hospices Civils de Lyon
• Investigators: Principal Investigator: Nadia ABID, MD, PhD, Hospices Civils de Lyon

Study record dates

Study Major Dates

• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2027

Study Registration Dates

• First Submitted: June 8, 2026
• First Submitted That Met QC Criteria: June 8, 2026
• First Posted (Actual): June 11, 2026

Study Record Updates

• Last Update Posted (Actual): June 11, 2026
• Last Update Submitted That Met QC Criteria: June 8, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Male Urogenital Diseases; Calculi; Pathological Conditions, Anatomical; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urolithiasis; Urinary Calculi; Urinary Bladder Diseases; Pathological Conditions, Signs and Symptoms; Urinary Bladder Calculi
• Other Study ID Numbers: 69HCL26_0256

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No