Flexible urétéroscopy Versus Extracorporeal Shockwave Lithotripsy in Renal Calculi

Not Applicable

Completed

• Conditions: Extracorporeal Shockwave Lithotripsy, Flexible Ureteroscopy

• Registration Number: NCT01604304
• Lead Sponsor: Hospices Civils de Lyon

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-05
• Study First Submitted: 2012-05-21
• Study First Submitted QC: 2012-05-22
• Study First Posted: 2012-05-23
• Primary Completion: 2014-02
• Study Completion: 2014-02
• Status Verified: 2014-08
• Last Update Submitted: 2019-05-23
• Last Update Posted: 2019-05-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Stone free rate	Three months	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.

Secondary Outcome Measures

Name	Time	Method
Stone free rate in weight's sub group	3 months	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
Stone free rate in sub group depending on stone diameters	3 months	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
Serious and non serious adverse events	3 months	In each arm will be evaluate rate of adverse event, type, severity.
Secondary procedure rate	3 months	In each arm will be evaluate rate of secondary procedure needed to have the best stone free rate

Trial Locations

Locations (1)

Service d'urologie, Hôpital Edouard Herriot; 🇫🇷 Lyon, France