Ultraslow Full-power SWL Versus Slow Power-ramping SWL in Stones With High Attenuation Value

Not Applicable

Completed

• Conditions: Renal Stones
• Interventions: Procedure: SWL

• Registration Number: NCT03763539
• Lead Sponsor: Cairo University

Brief Summary

Ultraslow full-power SWL versus slow power-ramping SWL in stones with high attenuation value

Detailed Description

To evaluate the efficacy of ultraslow rate of SWL versus slow rate, power ramping SWL.

Study Timeline

• Study Start: 2015-09
• Primary Completion: 2017-05
• Study Completion: 2018-05
• Status Verified: 2018-12
• Study First Submitted: 2018-12-01
• Study First Submitted QC: 2018-12-03
• Last Update Submitted: 2018-12-03
• Study First Posted: 2018-12-04
• Last Update Posted: 2018-12-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 196

Inclusion Criteria

• single renal stone less than or equal to 3 cm (2 cm for lower calyceal stones)
• radio-opaque stone
• high attenuation value (≥ 1000 HU) stone

Exclusion Criteria

• Abnormal renal anatomy
• renal insufficiency
• solitary kidney
• coagulopathies
• uncontrolled hypertension
• renal artery or aortic aneurysm
• active urinary tract infection
• pregnancy
• severe skeletal malformations (spinal deformity) precluding proper stone localization
• skin to stone distance (SSD) > 11 cm
• BMI > 30 Kgm/m2

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ultraslow shock wave lithotripsy (SWL)	SWL	SWL at ultraslow rate of 30 SW/min. Power ramping at the first 100 SW from 6 to 18 kv followed by safety pause for two minutes then power ramping from 18 to 22kv during the second 100 SW followed by safety pause for another two minutes. The rest of the session at 22kv (full power).
Slow power-ramping SWL	SWL	SWL at a slow rate of 60 SW/min. Power ramping from 6 - 10 kv during the first 500 SW then from 11 - 14 kv during the second 500 SW then from 15 - 18 kv during the following 500 SW then from 19 - 22 kv during the remaining 1000 - 1500 SW.

Primary Outcome Measures

Name	Time	Method
stone free rate	3 months following last session of SWL	Complete clearance of stones in addition to clinically insignificant residual fragments

Secondary Outcome Measures

Name	Time	Method
Complications	1 year following last session of SWL	Comparison of complications in both groups

Trial Locations

Locations (1)

Beni-Suef Hospitals; 🇪🇬 Banī Suwayf, Outside U.S./Canada, Egypt