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 | Not Yet Recruiting

• 1 other identifier: 69HCL26_0256
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 2

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Qol-DUCC questionnaire answers

  At inclusion

• Qualiveen questionnaire score

  At inclusion

Study Arms (4)

Trans-Stomal Bladder Lithotripsy Using Mini-Percutaneous Equipment

Patient operated on using Trans-Stomal Bladder Lithotripsy Using Mini-Percutaneous Equipment

Other: QoL-DUCC questionnaire; Other: Qualiveen Questionnaire

Trans-stomial bladder lithotripsy using flexible fibroscope

Patient operated on using Trans-stomial bladder lithotripsy using flexible fibroscope

Other: QoL-DUCC questionnaire; Other: Qualiveen Questionnaire

Percutaneous cystholithotripsy

Patient operated on using Percutaneous cystholithotripsy

Other: QoL-DUCC questionnaire; Other: Qualiveen Questionnaire

Open Cystolithotomy

Patient operated on using Open Cystolithotomy

Other: QoL-DUCC questionnaire; Other: Qualiveen Questionnaire

Interventions

QoL-DUCC questionnaire OTHER

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

Open Cystolithotomy; Percutaneous cystholithotripsy; Trans-Stomal Bladder Lithotripsy Using Mini-Percutaneous Equipment; Trans-stomial bladder lithotripsy using flexible fibroscope

Qualiveen Questionnaire OTHER

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

Open Cystolithotomy; Percutaneous cystholithotripsy; Trans-Stomal Bladder Lithotripsy Using Mini-Percutaneous Equipment; Trans-stomial bladder lithotripsy using flexible fibroscope

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (2)

Hôpital Edouard Herriot

Lyon, 69003, France

Location

Hôpital Lyon Sud

Pierre-Bénite, 69495, France

Location

MeSH Terms

Conditions

Urinary Bladder Calculi

Condition Hierarchy (Ancestors)

Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Calculi; Urolithiasis; Male Urogenital Diseases; Calculi; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Nadia ABID, MD, PhD

  Hospices Civils de Lyon

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nadia ABID, MD, PhD

CONTACT

+33 4 72 11 96 75; nadia.abid@chu-lyon.fr

Léonard TOTARO, MD

CONTACT

+33 613230009; leonard.totaro@chu-lyon.fr

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 8, 2026
• First Posted: June 11, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2027
• Last Updated: June 11, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

FR (2)