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

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorHospices Civils de Lyon

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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)

Trial population

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

Trial design

Design model

Other

Time perspective

Prospective

Treatments tested in this trial

  • QoL-DUCC questionnaire

    Other intervention

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

  • Qualiveen Questionnaire

    Other intervention

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

Treatment groups

80 Participants
are divided into 4 treatment groups
Group A: Trans-Stomal Bladder Lithotripsy Using Mini-Percutaneous Equipment2 interventions
Group B: Trans-stomial bladder lithotripsy using flexible fibroscope2 interventions
Group C: Percutaneous cystholithotripsy2 interventions
Group D: Open Cystolithotomy2 interventions

Trial outcomes

Primary outcomes

1

Residual stone size greater than 4mm postoperatively.

Residual stone size greater than 4mm postoperatively will be investigated on imaging control

Time frame
Up to 7 days after surgery

Secondary outcomes

1

Qol-DUCC questionnaire answers

answers to the Qol-DUCC questionnaire will be analysed to assess patient quality of life

Time frame
At inclusion
2

Qualiveen questionnaire score

The 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.

Time frame
At inclusion

Other outcomes

Sponsors and contacts

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