Effectiveness of Holmium and Thulium Lasers With Ureteroscopy for Urinary Lithiasis

Study Overview
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Brief Summary
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Holmium laser is the current gold standard for lithotripsy on urinary lithiasis, while Thulium is brand new. The latter has been released in July 2020 in Europe, and only in-vitro studies have been published. The aim of this study is to compare the stone free rate in ureteroscopy, for all consecutive patients treated with laser fragmentation, between both Holmium and Thulium lasers. The costs and complications will also be studied.

Official Title
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Ureteroscopy for Upper Tract Lithiasis : Comparison of Costs and Effectiveness of Both Holmium and Thulium Lasers, in a Prospective Monocentric Study.

Conditions
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Renal Stone, Ureteral Stone

Intervention / Treatment
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* Device: Ureteroscopy for upper tract stone treatment with Holmium laser
* Device: Ureteroscopy for upper tract stone treatment with Thulium laser


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: renal ou ureteral stone confirmed by an abdominal and pelvic computed tomography treatment with rigid or flexible ureteroscopy laser lithotripsy during the procedure bacteriological examination of urine (sterile, bacterial colonization or treated by antibiotics) Exclusion Criteria: non-use of laser for stone lithotripsy pregnant women under 18 years old refusal to give informed consent urinary malformation

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Holmium laser lithotripsy<br>Stone fragmentation are performed with Holmium laser in ureteroscopy | Device: Ureteroscopy for upper tract stone treatment with Holmium laser<br>* Rigid or flexible ureteroscopy for ureteral or renal stone. Lithotripsy with Holmium laser<br>|
| Thulium laser lithotripsy<br>Stone fragmentation are performed with Thulium laser in ureteroscopy | Device: Ureteroscopy for upper tract stone treatment with Thulium laser<br>* Rigid or flexible ureteroscopy for ureteral or renal stone. Lithotripsy with Thulium laser<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Stone free rate | Urinary tract echography or renal computer tomography imaging. Patients with residual fragments under 4 mm are stone free. | Three months after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Perioperative complications | Recording data about ureteric perforation and bleeding | During the intervention | 
| Operating time | All surgeries are included | Immediately after the intervention | 
| Postoperative complications | Recording data according to the Clavien classification (rates of hospitalisation, pain, infection and surgical revision) | Up to three months after surgery |