Ureteropelvic Junction Obstruction in Early Childhood: Comparison of Surgical Therapy and Surveillance. A Prospective, Randomized, Controlled Multi-Center Study (TOKU)
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ClinicalTrials.gov Identifier: NCT00444431 |
Recruitment Status : Unknown
Verified March 2007 by University Hospital, Essen.
Recruitment status was: Not yet recruiting
First Posted : March 7, 2007
Last Update Posted : March 7, 2007
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Unilateral Ureteropelvic Junction Obstruction | Procedure: Pyeloplasty | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Enrollment : | 240 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (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 |
Study Start Date : | March 2007 |
- partial renal function

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Ages Eligible for Study: | 4 Months to 6 Months (Child) |
Sexes Eligible for Study: | All |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00444431
Contact: Achim Rose, Md | 00492017233221 | roseachim@web.de |
Germany | |
University Hospital of Essen, Department of Pediatric Nephrology | |
Essen, Nordrhein-Westfalen, Germany, 45122 | |
Contact: Peter Hoyer, Prof. 00492017232810 peter.hoyer@uni-essen.de | |
Principal Investigator: Peter Hoyer, Prof. | |
University Hospital of Essen, Department of Urology | |
Essen, Nordrhein-Westfalen, Germany, 45122 | |
Contact: Herbert Rübben, Prof. 00492017233211 herbert.ruebben@uni-essen.de | |
Principal Investigator: Herbert Rübben, Prof. |
Principal Investigator: | Herbert Rübben, Prof. | University Hospital, Essen | |
Principal Investigator: | Peter Hoyer, Prof. | University Hospital, Essen |
ClinicalTrials.gov Identifier: | NCT00444431 |
Other Study ID Numbers: |
2005-004090-13 |
First Posted: | March 7, 2007 Key Record Dates |
Last Update Posted: | March 7, 2007 |
Last Verified: | March 2007 |
Hydronephrosis Ureteral Obstruction Multicystic Dysplastic Kidney Kidney Diseases Urologic Diseases |
Ureteral Diseases Urogenital Abnormalities Kidney Diseases, Cystic Congenital Abnormalities |