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

Unilateral Ureteropelvic Junction Obstruction Clinical Trial

— TOKU  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT00444431
• Other study ID #: 2005-004090-13
• Status: Not yet recruiting
• Phase: N/A
• First received: March 5, 2007
• Last updated: March 5, 2007
• Start date: March 2007

Study information

• Verified date: March 2007
• Source: University Hospital, Essen
• Contact: Achim Rose, Md
• Phone: 00492017233221
• Email: roseachim[@]web.de
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 240
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 4 Months to 6 Months

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Unilateral Ureteropelvic Junction Obstruction

Intervention

Procedure:
• Pyeloplasty

Locations

Country	Name	City	State
Germany	University Hospital of Essen, Department of Pediatric Nephrology	Essen	Nordrhein-Westfalen
Germany	University Hospital of Essen, Department of Urology	Essen	Nordrhein-Westfalen

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Essen

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	partial renal function