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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified March 2007 by University Hospital, Essen.
Recruitment status was:  Not yet recruiting
Information provided by:
University Hospital, Essen Identifier:
First received: March 5, 2007
Last updated: NA
Last verified: March 2007
History: No changes posted
In this randomized trial surgical therapy and surveillance of ureteropelvic junction obstruction will be compared, regarding partial renal function.

Condition Intervention
Unilateral Ureteropelvic Junction Obstruction
Procedure: Pyeloplasty

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Further study details as provided by University Hospital, Essen:

Primary Outcome Measures:
  • partial renal function

Estimated Enrollment: 240
Study Start Date: March 2007

Ages Eligible for Study:   4 Months to 6 Months   (Child)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT00444431

University Hospital of Essen, Department of Pediatric Nephrology
Essen, Nordrhein-Westfalen, Germany, 45122
University Hospital of Essen, Department of Urology
Essen, Nordrhein-Westfalen, Germany, 45122
Sponsors and Collaborators
University Hospital, Essen
Principal Investigator: Herbert Rübben, Prof. University Hospital, Essen
Principal Investigator: Peter Hoyer, Prof. University Hospital, Essen
  More Information Identifier: NCT00444431     History of Changes
Other Study ID Numbers: 2005-004090-13 
Study First Received: March 5, 2007
Last Updated: March 5, 2007
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Additional relevant MeSH terms:
Ureteral Obstruction
Multicystic Dysplastic Kidney
Kidney Diseases
Urologic Diseases
Ureteral Diseases
Urogenital Abnormalities
Kidney Diseases, Cystic
Congenital Abnormalities processed this record on December 09, 2016