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Urinary Tract DilatationNCT06764472

Retrospective Evaluation of a Cohort of Patients Diagnosed With Pre- and Postnatal Urinary Dilatation: Outcome and Long-term Follow-up

An observational study of Urinary Tract Dilatation, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 1 site in Italy.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

Retrospective evaluation of a cohort of patients diagnosed with pre- and postnatal urinary dilatation: outcome and long-term follow-up Read more about this study

Who is it for?
Ages Up to 16 years
Conditions the study is for
Urinary Tract Dilatation
How many people
600 participants
Where
1 siteItaly
Study dates
30 Jun 2020to 31 Dec 2025
Phase
Observational
Are there results?
Not yet: the study is under way

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 Up to 16 years
  • All sexes
  • No healthy volunteers
  • Child

Study population: Patients aged 0-16 years who were referred to the departments and/or outpatient clinics of the participating centers for urinary tract dilataions from January 2000 to August 31 2021. The estimated number of patients to enroll is between 1500 and 2000.

Who may be able to join

  • Pediatric patients referred to one of the participating centers between January 1 2000 and August 31 2021 for either a prenatal or a postnatal diagnosis of urinary tract dilatation;
  • Urinary tract dilatation documented on at least one postnatal ultrasound, with related measurements;
  • Presence of at least one other ultrasound performed during follow-up in the postnatal period.

Who cannot join

  • Lack of some of the clinical data considered crucial to the study, particularly incomplete ultrasound reports referable to at least two different ultrasounds performed in follow-up;
  • Dilatation with a picture of documented renal lithiasis.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Claudio La Scola, MD, PhD contact

00390512144650

claudio.lascola@aosp.bo.it

Italy1 site, 1 recruiting
  • IRCCS Azienda Ospedaliero-Universitaria di Bologna

    Bologna, 40138

    Claudio La Scola, MD, PhD, 00390512144650, claudio.lascola@aosp.bo.it

    Claudio La Scola, Md, PhD

    Recruiting

Other trials in Italy

About this study

Retrospective evaluation of a cohort of patients diagnosed with pre- and postnatal urinary dilatation: outcome and long-term follow-up

Read the detailed description

Urinary tract dilatation is one of the most frequently encountered congenital anomalies in children. Significant improvements in imaging have made it possible to diagnose it earlier, which has led to a major increase in findings during the prenatal period. Before prenatal ultrasound screening became routine, congenital malformations of the kidneys and urinary tract were not diagnosed until they caused symptoms in childhood or occasionally in adult life. Now the vast majority are identified in utero and can be managed prospectively. Antenatal ultrasound diagnosis of urinary tract dilatation is estimated to affect around 1-2% of all pregnancies, and most frequently affects the male sex at a ratio of about 2:12.

The primary goal behind early diagnosis is to be able to monitor the detected abnormalities over time, trying to prevent the onset of possible complications and thus minimize progressive renal damage. However, a disadvantage of this increasing diagnostic accuracy is that it allows the detection of even the smallest of abnormalities, most commonly mild unilateral dilatations of the renal pelvis, which although they have no pathological significance and do not require any kind of intervention, can lead to excessive investigations, unnecessary treatments, and unwarranted anxiety in parents.

The postnatal diagnosis of urinary dilatations not reported on ultrasound scans performed during pregnancy can be traced mainly to three conditions: screening ultrasound scans performed during childhood, kidney and urinary tract monitoring following an intercurrent acute episode such as a urinary tract infection or acute abdominal pain, and follow-up ultrasound scans performed during a hospital stay for another reason.

The presence of urinary tract dilatation can correspond to a spectrum of possible etiologies and underlying nephro-urologic pathologies. In many cases, it is not possible to clarify the underlying etiology of urinary tract dilatation prenatally; rather, it is necessary to wait until the birth and then proceed with in-depth diagnostic investigations based on both first-level imaging methods, such as ultrasonography, and second-level imaging methods, such as micturition cystourethrography (CUM)2 and renal scintigraphy.

Despite the high prevalence, there is still significant variability in the postnatal management of patients diagnosed with urinary dilatation because of the paucity of existing evidence-based correlations between the type of dilatation and the underlying nephro-urologic pathology. This results, in some cases, in the use of unnecessary examinations, which may expose the child to radiation and stress e.g. bladder catheterization for cystography.

The primary aim of this study is to evaluate the diagnostic framing, progression, and different outcomes of patients diagnosed with urinary tract dilatation, considering patients in whom prenatal or postnatal diagnosis was made. The secondary aims are to identify which dilatations are significant, deserving of close follow-up and second-tier examinations (particularly CUM and renal scintigraphy), and to assess the appropriate timing for such examinations, an to assess if the need for postnatal screening is warranted, or whether prenatal screening is sufficient, comparing risk and benefit factors.

Keywords
Urinary Tract Dilatation, Children, Ultrasound, Postnatal diagnosis, Prenatal diagnosis

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Size parameters

    dilatations of the renal pelvis, renal calices and ureter

    Measured: at baseline

  2. Presence of hyperecogenicity

    yes/no

    Measured: at baseline

  3. Presence of renal and/or bladder abnormalities

    yes/no

    Measured: at baseline

  4. Polar diameter of the kidneys

    mm

    Measured: at baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Jan 2025
  2. Study start30 Jun 2020
  3. Primary completion31 Dec 2025 (estimated)
  4. Study completion31 Dec 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Retrospective
Enrolment
600 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06764472
Sponsor's protocol ID
DUCT
Status last verified
Dec 2024
First submitted
2 Jan 2025
Last updated
8 Jan 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of Urinary Tract Dilatation, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 1 site in Italy.

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 3 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 8 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Italy. 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Claudio La Scola, MD, PhD (00390512144650, claudio.lascola@aosp.bo.it), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Size parameters (time frame: at baseline). The study lists 4 primary outcomes in all. 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 8 Jan 2025.

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