Trial Outcomes & Findings for Impact of Renal Anatomy on Shock Wave Lithotripsy Outcomes for Lower Pole Kidney Stones (NCT NCT01589484)

Results Overview

After 12 weeks, all patients will be submitted to a new NCCT scan to evaluate stone fragmentation and stone clearance.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

104 participants

Primary outcome timeframe

12 weeks after SWL

Results posted on

2015-01-07

Participant milestones
Measure	Shockwave Lithotripsy (SWL) All patients were submitted to a noncontrast computed tomography before to shockwave lithotripsy (SWL). Patients were submitted to SWL under the following conditions: outpatient, general anesthesia, 3000 impulses, rate of 90/min, discharged from hospital in the same day with alpha-blocker (doxazosin) during 30 days.
Overall Study STARTED	104
Overall Study COMPLETED	100
Overall Study NOT COMPLETED	4

Withdrawal data not reported

Impact of Renal Anatomy on Shock Wave Lithotripsy Outcomes for Lower Pole Kidney Stones

Baseline characteristics by cohort
Measure	Shockwave Lithotripsy (SWL) n=100 Participants One hundred patients fulfilled the inclusion and exclusion criteria and were enrolled in this study. Mean age and BMI were 47.1 years and 28.0 Kg/m2, respectively. Half of patients had their stone localized in the right kidney. Mean stone size was 9.1mm and mean stone density was 795 HU.
Age, Continuous	47.1 years STANDARD_DEVIATION 12.5 • n=93 Participants
Sex: Female, Male Female	50 Participants n=93 Participants
Sex: Female, Male Male	50 Participants n=93 Participants
Region of Enrollment Brazil	100 participants n=93 Participants
BMI	28.0 Kg/m2 STANDARD_DEVIATION 4.7 • n=93 Participants
Waist abdominal circumference	94.1 cm STANDARD_DEVIATION 12.7 • n=93 Participants

Timeframe: 12 weeks after SWL

Population: Fragmentation

After 12 weeks, all patients will be submitted to a new NCCT scan to evaluate stone fragmentation and stone clearance.

Outcome measures
Measure	Primary Endoint n=100 Participants Shock wave lithotripsy outcome
Stone Clearance	76 participants

Timeframe: 12 weeks after SWL

Secondary endpoint will be SWL complications (i.e. pain, hematuria, urinary tract infection, Steinstrasse)

Outcome measures
Measure	Primary Endoint n=100 Participants Shock wave lithotripsy outcome
SWL Complications	7 participants

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Adverse event data not reported

Adverse event data not reported

University of Sao Paulo Medical School

Phone: +55 11 94308951