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.
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.
Italy1 site, 1 recruiting
- 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
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.
- Conditions
- Urinary Tract Dilatation
- 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.
Size parameters
dilatations of the renal pelvis, renal calices and ureter
Measured: at baseline
Presence of hyperecogenicity
yes/no
Measured: at baseline
Presence of renal and/or bladder abnormalities
yes/no
Measured: at baseline
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.
- First posted8 Jan 2025
- Study start30 Jun 2020
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urinary Tract DilatationStudies of the same condition, open and under way.
- More trials run by IRCCS Azienda Ospedaliero-Universitaria di BolognaThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Claudio La Scola, MD, Principal investigator, IRCCS Azienda Ospedaliero-Universitaria di Bologna
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
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective Evaluation of a Cohort of Patients Diagnosed With Pre- and Postnatal Urinary Dilatation: Outcome and Long-term Follow-up
- ClinicalTrials.gov ID
- NCT06764472
- Acronym / sponsor ID
- DUCT
- Conditions
- Urinary Tract Dilatation
- Keywords
- Urinary Tract Dilatation, Children, Ultrasound, Postnatal diagnosis, Prenatal diagnosis
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- IRCCS Azienda Ospedaliero-Universitaria di BolognaUniversity, hospital or other
- Study start
- 30 Jun 2020 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 8 Jan 2025 (actual)
- 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.
Retrospective evaluation of a cohort of patients diagnosed with pre- and postnatal urinary dilatation: outcome and long-term follow-up
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- Up to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Size parameters
Time frame: at baseline
dilatations of the renal pelvis, renal calices and ureter
Presence of hyperecogenicity
Time frame: at baseline
yes/no
Presence of renal and/or bladder abnormalities
Time frame: at baseline
yes/no
Polar diameter of the kidneys
Time frame: at baseline
mm
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2025.
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.
Claudio La Scola, MD principal investigator
IRCCS Azienda Ospedaliero-Universitaria di Bologna
1 site in 1 country: see every site and its status.
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.