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

University Hospital Essen

Status: Unknown

Conditions: Unilateral Ureteropelvic Junction Obstruction

Treatments: Procedure: Pyeloplasty

Study type: Interventional

Funder types: Other

Identifiers

NCT00444431

2005-004090-13

Details and patient eligibility

About

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

Sex: All

Ages: 4 to 6 months old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)