Ureteropelvic Junction Obstruction in Early Childhood: Comparison of Surgical Therapy and Surveillance. A Prospective, Randomized, Controlled Multi-Center Study

Not Applicable

• Conditions: Unilateral Ureteropelvic Junction Obstruction

• Registration Number: NCT00444431
• Lead Sponsor: University Hospital, Essen

Brief Summary

In this randomized trial surgical therapy and surveillance of ureteropelvic junction obstruction will be compared, regarding partial renal function.

Detailed Description

Not available

Study Timeline

• Status Verified: 2007-03
• Study Start: 2007-03
• Study First Submitted: 2007-03-05
• Study First Submitted QC: 2007-03-05
• Last Update Submitted: 2007-03-05
• Study First Posted: 2007-03-07
• Last Update Posted: 2007-03-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 240

Inclusion Criteria

• unilateral ureteropelvic junction obstruction
• diameter of renal pelvis greater 12 mm
• partial renal function of 35%-55% proofed by scintigraphy
• urodynamically relevant decrease in renal drainage proofed by diuresis scintigraphy at the age of 4 weeks up to 6 months
• Abscence of clinical symptoms
• Healthy contralateral kidney

Exclusion Criteria

• Global decrease in renal function
• renal dystopia
• megaureter
• vesico-ureteral reflux
• progressive hydronephrosis
• oligohydrammnion
• voiding dysfunction
• bilateral hydronephrosis
• severe chronical illness
• decrease of partial renal function of more then 5% during allocation

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
partial renal function

Trial Locations

Locations (2)

University Hospital of Essen, Department of Pediatric Nephrology; 🇩🇪 Essen, Nordrhein-Westfalen, Germany

University Hospital of Essen, Department of Urology; 🇩🇪 Essen, Nordrhein-Westfalen, Germany