Stepwise Shock Wave Lithotripsy in Pediatric Urolithiasis

Not Applicable

Completed

• Conditions: Pediatric Urinary Lithiasis

• Registration Number: NCT01807260
• Lead Sponsor: TC Erciyes University

Brief Summary

To evaluate and compare the results of conventional and stepwise shock wave lithotripsy treatment modalities in pediatric urinary lithiasis.

Detailed Description

Between March 2008 and February 2012, 81 patients were randomized and included in this study. Shock wave lithotripsy was performed by using a Dornier Compact Delta instrument. Localizations of radiopaque and non-opaque stones were estimated by using flouroscopy and ultrasonography, respectively. Treatment energy was set on 13 kV in the conventional group. In the stepwise group, treatment energy was initially set on 10 kV and gradually increased up to 13 kV per 250 shocks. The maximum numbers of shocks in both groups were limited to 3000. Patients were followed up with 15 days interval. In each visit, patients were respectively questioned for pain, hematuria and history of stone passage. In case of treatment failure, shock wave lithotripsy was repeated.

Study Timeline

• Study Start: 2008-03
• Primary Completion: 2012-02
• Study Completion: 2012-06
• Study First Submitted: 2013-02-28
• Status Verified: 2013-03
• Study First Submitted QC: 2013-03-06
• Last Update Submitted: 2013-03-06
• Study First Posted: 2013-03-08
• Last Update Posted: 2013-03-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 81

Inclusion Criteria

The patients with pediatric urinary lithiasis.

Exclusion Criteria

Resistant urinary tract infections Coagulopathies Anatomically obstructed urinary system

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Stone burden on plain X-ray.	Three months.	The stone burden was defined as the stone area that was calculated by multiplying the largest length(cm)and width (cm)of the individual stones measured from the abdominal plain X-ray. To detect fragmentation of the stone and necessity of re-treatment a plain film were used during control. Stone clearance was assessed at three months. Stone-free state was defined as the absence of stone fragments on a good quality plain X-ray. Clinical success was considered if the residual fragments were 2-3 mm or less in asymptomatic patients.

Trial Locations

Locations (1)

Department of Urology, Erciyes University Medical Faculty,; 🇹🇷 Kayseri, Talas, Turkey