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Status unknownNCT00444431TOKUUpdated Mar 7, 2007

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

An interventional study of Pyeloplasty in Unilateral Ureteropelvic Junction Obstruction, sponsored by University Hospital, Essen. Status unknown at 2 sites in Germany. Open to participants aged 4 Months to 6 Months. Per ClinicalTrials.gov, last updated 2007-03-07.

Sponsored by University Hospital, Essen · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Mar 2007), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
240
Allocation
Randomized
Ages
4 Months to 6 Months
Sex
All
01

Study summary

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

02

Conditions studied

  • Unilateral Ureteropelvic Junction Obstruction
03

In context

Hydronephrosis

64 studies on the registry are indexed under Hydronephrosis; 12 are open to participants now.

This study's enrollment of 240 is above the median of 54 across 34 interventional studies indexed under Hydronephrosis.

Browse Hydronephrosis studies →

Lead sponsor

University Hospital, Essen is the lead sponsor of 111 studies on the registry; 35 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
4 Months to 6 Months
Sexes eligible
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

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
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
240 participants

Interventions

  • ProcedurePyeloplasty
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What researchers measure

Primary outcomes

  1. partial renal function

07

Study locations

2 sites
  • University Hospital of Essen, Department of Pediatric Nephrology
    Essen, Nordrhein-Westfalen 45122, Germany
  • University Hospital of Essen, Department of Urology
    Essen, Nordrhein-Westfalen 45122, Germany
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 7, 2007, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00444431
Lead sponsor
University Hospital, Essen
First posted
Mar 7, 2007
Start date
Mar 2007
Last update
Mar 7, 2007

Study contacts

Achim Rose, Md
Contact
roseachim@web.de
00492017233221
Herbert Rübben, Prof.
principal investigator · University Hospital, Essen
Peter Hoyer, Prof.
principal investigator · University Hospital, Essen

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Mar 2007. You cannot join it, but the record below documents what was studied.

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