Unilateral Ureteropelvic Junction ObstructionTOKUNCT00444431
Ureteropelvic Junction Obstruction in Early Childhood: Comparison of Surgical Therapy and Surveillance. A Prospective, Randomized, Controlled Multi-Center Study
A study testing Pyeloplasty in people with Unilateral Ureteropelvic Junction Obstruction, run by University Hospital, Essen at 2 sites in Germany.
Trial summary
In this randomized trial surgical therapy and surveillance of ureteropelvic junction obstruction will be compared, regarding partial renal function. Read more about this study
- Who is it for?
- Ages 4 to 6 months
- Conditions the study is for
- Unilateral Ureteropelvic Junction Obstruction
- What is being tested?
- Pyeloplasty
- Type of treatment
- Surgery or procedure
- How many people
- 240 participants
- Where
- 2 sitesGermany
- Study dates
- Mar 2007to not given
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 6 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- Global decrease in renal function
- renal dystopia
- megaureter
- vesico-ureteral reflux
- progressive hydronephrosis
- oligohydrammnion
Show all 10Show fewer
- voiding dysfunction
- bilateral hydronephrosis
- severe chronical illness
- decrease of partial renal function of more then 5% during allocation
Trial locations and contacts
2 sites in 1 country.
Germany2 sites
University Hospital of Essen, Department of Pediatric Nephrology
Essen, North Rhine-Westphalia, 45122
Peter Hoyer, Prof., 00492017232810, peter.hoyer@uni-essen.de
Peter Hoyer, Prof.
University Hospital of Essen, Department of Urology
Essen, North Rhine-Westphalia, 45122
Herbert Rübben, Prof., 00492017233211, herbert.ruebben@uni-essen.de
Herbert Rübben, Prof.
About this study
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
In this randomized trial surgical therapy and surveillance of ureteropelvic junction obstruction will be compared, regarding partial renal function.
- Being tested
- Pyeloplasty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PyeloplastyProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
partial renal function
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2007 (estimated)
- Study startMar 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Unilateral Ureteropelvic Junction ObstructionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 240 participants
Sponsor and investigators
- Lead sponsor
- University Hospital, Essen
- Sponsor type
- University, hospital or other
- Investigators
- Herbert Rübben, Prof., Principal investigator, University Hospital, EssenPeter Hoyer, Prof., Principal investigator, University Hospital, Essen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00444431
- Sponsor's protocol ID
- 2005-004090-13
- Other IDs
- 2005
- Acronym
- TOKU
- Status last verified
- Mar 2007
- First submitted
- 5 Mar 2007
- Last updated
- 7 Mar 2007
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00444431
- Acronym / sponsor ID
- TOKU / 2005-004090-13
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 240 participants
- Lead sponsor
- University Hospital, EssenUniversity, hospital or other
- Study start
- Mar 2007
- First posted
- 7 Mar 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In this randomized trial surgical therapy and surveillance of ureteropelvic junction obstruction will be compared, regarding partial renal function.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 4 to 6 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (10 listed)
- Global decrease in renal function
- renal dystopia
- megaureter
- vesico-ureteral reflux
- progressive hydronephrosis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pyeloplasty | Procedure or surgery | – |
Primary outcome
partial renal function
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2007.
Related trials for Unilateral Ureteropelvic Junction Obstruction
RecruitingObservational study
Renal SWE as a Predictor After Pediatric Pyeloplasty for UPJO
Ureteropelvic Junction Obstruction, Renal Functional Recovery
RecruitingObservational study
The PRO-FUTURE Project
Ureteropelvic Junction Obstruction, Chronic Kidney Diseases
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Herbert Rübben, Prof. principal investigator
University Hospital, Essen
Peter Hoyer, Prof. principal investigator
University Hospital, Essen
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pyeloplasty in people with Unilateral Ureteropelvic Junction Obstruction, run by University Hospital, Essen at 2 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Mar 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Achim Rose, Md (00492017233221, roseachim@web.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
partial renal function. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Mar 2007.