Flexible urétéroscopy Versus Extracorporeal Shockwave Lithotripsy in Renal Calculi

Hospices Civils de Lyon30 enrolled

Overview

Flexible ureteroscopy is a recent procedure to treat renal stone. Extracorporeal shockwave lithotripsy was the gold standard treatment for calculi between 5 and 20 mm. In literature, the two procedures are available to treat these stones with a good stone free rate. There is no prospective randomized study comparing these two treatments. Our study will define with a good level of evidence which technique is the best with regard to the stone free rate, secondary procedure rate and adverse effect.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Extracorporeal Shockwave Lithotripsy, Flexible Ureteroscopy

Interventions

flexible ureteroscopyPROCEDURE

Flexible ureteroscopy will be use for 120 min max to treat renal stone. Laser, access sheath, baskets can be use to perform the technique.

extracorporeal shockwave lithotripsyPROCEDURE

The lithotriptor is use with 1,1 Hz frequency and stop when patient get 1000 joules of energy or if there is a problem with tolerance of this treatment or if stone is broken

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patient with 5 to 20 mm renal stone * Age ≥ 18 years old * Patient agreement signed * BMI \< 35 * Contraception Exclusion Criteria: * Pregnancy * Severe musculoskeletal deformities * Renal artery or aorta aneurysm * Pacemaker * Anesthesia contra indication * Psychiatric trouble or law protection

Locations (1)

Service d'urologie, Hôpital Edouard Herriot

Lyon, France

Outcomes

Primary Outcomes

Stone free rate

Rate of stone free patient or patient with residual fragment ≤ 3 mm, 3 months after the treatment evaluated, will be compare. This outcome is measured with a tomodensitometry and compares with pre treatment exams.

Time frame: Three months

Secondary Outcomes

Stone free rate in weight's sub group

Each arm wil be divise in 3 sub group based on body mass index (20 to 25, 25 to 30, 30 to 35). We'll compare rate of efficacity in each sub group

Time frame: 3 months

Stone free rate in sub group depending on stone diameters

Each arm wil be divise in 3 sub group based on calculi diameter (5 to 10mm, 10 to 15 and 15 to 20). We'll compare rate of efficacity in each sub group

Time frame: 3 months

Secondary procedure rate

In each arm will be evaluate rate of secondary procedure needed to have the best stone free rate

Time frame: 3 months

Serious and non serious adverse events

In each arm will be evaluate rate of adverse event, type, severity.

Time frame: 3 months

Data from ClinicalTrials.gov

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