Stepwise Shock Wave Lithotripsy in Pediatric Urolithiasis

• ClinicalTrials.gov Identifier: NCT01807260
• Recruitment Status: Completed
• First Posted: March 8, 2013
• Last Update Posted: March 8, 2013
• Sponsor: TC Erciyes University
• Information provided by (Responsible Party): Abdullah Demirtas, TC Erciyes University

Study Description

Brief Summary:

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

Condition or disease	Intervention/treatment	Phase
Pediatric Urinary Lithiasis	Procedure: Shock wave lithotripsy	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 81 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: STEPWISE SHOCK WAVE LITHOTRIPSY IN PEDIATRIC UROLITHIASIS: A COMPARATIVE STUDY.
• Study Start Date: March 2008
• Actual Primary Completion Date: February 2012
• Actual Study Completion Date: June 2012

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: conventional Shock wave lithotripsy group; All procedures were performed under continu¬ous intravenous sedo-analgesia (using a combi-nation of ketamine 1 mg/kg and propofol 0,5-1 mg/kg) with fluoroscopic or ultrasonograpic imaging in a supine position. Shock wave number was limited to a maximum of 3000 waves/session. In the conventional group the voltage was only 13 kV. The stone burden was defined as the stone area that was calculated by multiply¬ing the largest length and width of the individual stones measured from the abdominal plain X-ray.	Procedure: Shock wave lithotripsy; All procedures were performed under continuous intravenous sedo-analgesia (using a combination of ketamine 1 mg/kg and propofol 0,5-1 mg/kg) with fluoroscopic or ultrasonograpic imaging in a supine position. Shock wave lithotrpisy was poerformed with a Dornier Compact Delta lithotripter (Dornier Medtech, Germany). Shock wave number was limited to a maximum of 3000 waves/session. In the conventional group the voltage was only 13 kV. The stone burden was defined as the stone area that was calculated by multiplying the largest length and width of the individual stones measured from the abdominal plain X-ray.
Active Comparator: stepwise Shock wave lithotripsy group; All procedures were performed under continu¬ous intravenous sedo-analgesia (using a combi-nation of ketamine 1 mg/kg and propofol 0,5-1 mg/kg) with fluoroscopic or ultrasonograpic imaging in a supine position. Shock wave number was limited to a maximum of 3000 waves/session. In the stepwise group, the voltage was started at 10 kV and increased stepwise (every 250 shock waves) to 13 kV. The stone burden was defined as the stone area that was calculated by multiply¬ing the largest length and width of the individual stones measured from the abdominal plain X-ray.	Procedure: Shock wave lithotripsy; All procedures were performed under continuous intravenous sedo-analgesia (using a combination of ketamine 1 mg/kg and propofol 0,5-1 mg/kg) with fluoroscopic or ultrasonograpic imaging in a supine position. Shock wave lithotrpisy was poerformed with a Dornier Compact Delta lithotripter (Dornier Medtech, Germany). Shock wave number was limited to a maximum of 3000 waves/session. In the conventional group the voltage was only 13 kV. The stone burden was defined as the stone area that was calculated by multiplying the largest length and width of the individual stones measured from the abdominal plain X-ray.

Outcome Measures

Primary Outcome Measures :

1. Stone burden on plain X-ray. [ Time Frame: 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.

Other Outcome Measures:

1. Degree and presence of hydronephrosis. [ Time Frame: Three months ]
   To detect obstruction in the system, ultrasonography was used during control.
2. Stone burden on spiral computed tomography [ Time Frame: Three months ]
   In case of non-opaque Stones, stone borden was evalusted with spinal computed tomography. Clinical success was considered if the residual fragments were 2-3 mm or less in asymptomatic patients.

Eligibility Criteria

• Ages Eligible for Study: 12 Months to 16 Years (Child)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

The patients with pediatric urinary lithiasis.

Exclusion Criteria:

Resistant urinary tract infections Coagulopathies Anatomically obstructed urinary system

Contacts and Locations

Locations

Turkey

Department of Urology, Erciyes University Medical Faculty,

Kayseri, Talas, Turkey, 38280

Sponsors and Collaborators

TC Erciyes University

Investigators

• Study Chair: Deniz Demirci, Prof.; Department of Urology, Erciyes University Medical faculty,

More Information

Publications of Results:

Demirci D, Altiok E, Gülmez I, Ekmekçioğlu O, Poyrazoğlu HM. Stepwise shock wave lithotripsy: results of initial study for the treatment of urinary stones in childhood. Int Urol Nephrol. 2006;38(2):189-92.

• Responsible Party: Abdullah Demirtas, Assistant Professor, TC Erciyes University
• ClinicalTrials.gov Identifier: NCT01807260
• Other Study ID Numbers: stepwise0946
• First Posted: March 8, 2013
• Last Update Posted: March 8, 2013
• Last Verified: March 2013

Additional relevant MeSH terms:

Urolithiasis; Urinary Calculi; Lithiasis; Urologic Diseases; Calculi; Pathological Conditions, Anatomical; Pathologic Processes