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

Cairo University (CU)

Status: Completed

Conditions: Renal Stones

Treatments: Procedure: SWL

Study type: Interventional

Funder types: Other

Identifiers

NCT03763539

5124

Details and patient eligibility

About

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

Full description

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

Enrollment: 196 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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196 participants in 2 patient groups

Ultraslow shock wave lithotripsy (SWL)

Active Comparator group

Description:

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).

Treatment:

Procedure: SWL

Slow power-ramping SWL

Active Comparator group

Description:

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.

Treatment:

Procedure: SWL