ESWL: Ultraslow SWL Versus Slow SWL for Ureteric Stones With High Attenuation Value

Sponsor

Cairo University (Other)

Overall Status

Completed

CT.gov ID

NCT03795545

Collaborator

Beni-Suef University (Other)

101

Enrollment

Location

Arms

Actual Duration (Months)

14.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Ureteric Stone	Procedure: SWL	N/A

Detailed Description

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

Study Design

Study Type:

Interventional

Actual Enrollment :

101 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jan 11, 2019

Actual Primary Completion Date :

Jul 16, 2019

Actual Study Completion Date :

Aug 12, 2019

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Ultraslow shock wave lithotripsy (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).	Procedure: SWL Shock wave lithotripsy Other Names: ESWL
Active Comparator: Slow power-ramping 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.	Procedure: SWL Shock wave lithotripsy Other Names: ESWL

Arm

Intervention/Treatment

Active Comparator: Ultraslow shock wave lithotripsy (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).

Procedure: SWL

Shock wave lithotripsy

Other Names:

ESWL

Active Comparator: Slow power-ramping 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.

Procedure: SWL

Shock wave lithotripsy

Other Names:

ESWL

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

Complications rate [3 months following last session of SWL]
Comparison of rate of complications in both groups

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

single upper ureteric stone less than or equal to 2 cm
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