EnuresisNCT06764498
Retrospective Study to Evaluate the Effectiveness of the Approach to Enuresis in Our Center
An observational study of Enuresis, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 1 site in Italy.
Trial summary
Retrospective study to evaluate the effectiveness of the approach to enuresis at IRCCS Azienda Ospedaliero-Universitaria of Bologna Policlinico di Sant'Orsola, Italy. Read more about this study
- Who is it for?
- Ages Up to 17 years
- Conditions the study is for
- Enuresis
- How many people
- 200 participants
- Where
- 1 siteItaly
- Study dates
- 10 Feb 2022to 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 17 years
- All sexes
- No healthy volunteers
- Child
Study population: Since this is a descriptive study, a formal calculation of sample size is not expected. However, about 150-200 subjects are expected to be enrolled.
Who may be able to join
- Patients of either sex under the age of 18 years at the time of the first outpatient visit;
- Patients clinically evaluated in the outpatient clinic during the period 01/05/2019- 31/05/2021 with a diagnosis of enuresis;
- Patients presenting at least two outpatient follow-ups;
- Informed consent signed by parent or legal guardian.
Who cannot join
- Patients older than 18 years of age;
- Patients who lack completed night and daily diaries;
- Patients with continuous incontinence;
- Patients with neurological disorders and/or signs of spinal occult dysraphism;
- Patients with a severe cognitive disorder.
Trial locations and contacts
1 site in 1 country.
About this study
Retrospective study to evaluate the effectiveness of the approach to enuresis at IRCCS Azienda Ospedaliero-Universitaria of Bologna Policlinico di Sant'Orsola, Italy.
Read the detailed description
Enuresis is an extremely common condition that affects 5-10% of 7-year-olds and 3% of adolescents and persists in 2% of adults. Although in most cases it is not related to comorbidities and more serious illnesses, enuresis can have long-term negative impacts on the psychological sphere of both the children by leading to low self-esteem, anxiety, and embarrassment and the entire family by leading to stress and intolerance toward the condition and an overall reduction in quality of life.
Enuresis is defined as the involuntary loss of urine during sleep that occurs at least twice a week in a sleeping child older than 5 years. It is classified into primary, if the child has never achieved continence, or secondary if it appears after an enuresis-free period of at least 6 months. It can be further subdivided into monosymptomatic and non-monosymptomatic enuresis, the latter defined by the coexistence of daytime incontinence or lower urinary tract symptoms such as daytime incontinence, urgency, difficulty urinating, and low/high daytime urinary frequency.
There are multiple guidelines in the literature regarding the approach to be taken for the management of enuresis. In 2015 from a consensus among the leading international pediatric urology and nephrology societies, practical guidelines to the approach to the pediatric enuretic patient were developed.
Two main types of approach are proposed in this paper, one of which has been adopted in our center and represents a more scrupulous modality in that during the first visit, not only useful advice on good urination practices is given, but also two diaries, one "daily" which assesses the volume of fluid ingested, the amount of urine produced daily, and urinary leakage the other "nocturnal" through which parameters such as bladder capacity and the amount of urine produced during the night are investigated, which allow not only to distinguish between monosymptomatic and non-monosymptomatic enuresis, but also to provide an objective method on which to base the choice of possible therapy - alert or desmopressin - which is therefore not provided before a second clinical checkup. Given the large number of pediatric patients referred to our Center for the problem of enuresis, this study aims to analyze the effectiveness of the methodology adopted on the resolution of this condition.
The primary aim of this study is to assess the resolution rate of enuresis in our population. The secondary aims of this study are to evaluate the effectiveness of the proposed pharmacological treatments, and to evaluate the correlation between constipation and enuresis.
- Conditions
- Enuresis
- Keywords
- Enuresis, Children
- Medical subject headings
- Enuresis
What is being measured
The primary outcome is the main question the study is designed to answer.
Daily urinary frequency
increase (≥8 micturitions/day) or decrease (≤3 micturitions/day)
Measured: at baseline
Maximum Voided Volume (MVV)
volume of urine emitted in 24 hours, excluding first morning urine
Measured: at baseline
Bladder capacity
reduction (<35% of expected bladder capacity) or increase (> 150% of expected bladder capacity)
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 start10 Feb 2022
- 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 EnuresisStudies 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
- 200 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Andrea Pasini, MD, Principal investigator, IRCCS Azienda Ospedaliero-Universitaria di Bologna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06764498
- Sponsor's protocol ID
- ENU-PED-21-02
- 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 Study to Evaluate the Effectiveness of the Approach to Enuresis in Our Center
- ClinicalTrials.gov ID
- NCT06764498
- Acronym / sponsor ID
- ENU-PED-21-02
- Conditions
- Enuresis
- Keywords
- Enuresis, Children
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- IRCCS Azienda Ospedaliero-Universitaria di BolognaUniversity, hospital or other
- Study start
- 10 Feb 2022 (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 study to evaluate the effectiveness of the approach to enuresis at IRCCS Azienda Ospedaliero-Universitaria of Bologna Policlinico di Sant'Orsola, Italy.
Detailed description
Enuresis is an extremely common condition that affects 5-10% of 7-year-olds and 3% of adolescents and persists in 2% of adults. Although in most cases it is not related to comorbidities and more serious illnesses, enuresis can have long-term negative impacts on the psychological sphere of both the children by leading to low self-esteem, anxiety, and embarrassment and the entire family by leading to stress and intolerance toward the condition and an overall reduction in quality of life.
Enuresis is defined as the involuntary loss of urine during sleep that occurs at least twice a week in a sleeping child older than 5 years. It is classified into primary, if the child has never achieved continence, or secondary if it appears after an enuresis-free period of at least 6 months. It can be further subdivided into monosymptomatic and non-monosymptomatic enuresis, the latter defined by the coexistence of daytime incontinence or lower urinary tract symptoms such as daytime incontinence, urgency, difficulty urinating, and low/high daytime urinary frequency.
There are multiple guidelines in the literature regarding the approach to be taken for the management of enuresis. In 2015 from a consensus among the leading international pediatric urology and nephrology societies, practical guidelines to the approach to the pediatric enuretic patient were developed.
Two main types of approach are proposed in this paper, one of which has been adopted in our center and represents a more scrupulous modality in that during the first visit, not only useful advice on good urination practices is given, but also two diaries, one "daily" which assesses the volume of fluid ingested, the amount of urine produced daily, and urinary leakage the other "nocturnal" through which parameters such as bladder capacity and the amount of urine produced during the night are investigated, which allow not only to distinguish between monosymptomatic and non-monosymptomatic enuresis, but also to provide an objective method on which to base the choice of possible therapy - alert or desmopressin - which is therefore not provided before a second clinical checkup. Given the large number of pediatric patients referred to our Center for the problem of enuresis, this study aims to analyze the effectiveness of the methodology adopted on the resolution of this condition.
The primary aim of this study is to assess the resolution rate of enuresis in our population. The secondary aims of this study are to evaluate the effectiveness of the proposed pharmacological treatments, and to evaluate the correlation between constipation and enuresis.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- Up to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Since this is a descriptive study, a formal calculation of sample size is not expected. However, about 150-200 subjects are expected to be enrolled.
Key inclusion criteria (4 listed)
- Patients of either sex under the age of 18 years at the time of the first outpatient visit;
- Patients clinically evaluated in the outpatient clinic during the period 01/05/2019- 31/05/2021 with a diagnosis of enuresis;
- Patients presenting at least two outpatient follow-ups;
- Informed consent signed by parent or legal guardian.
Key exclusion criteria (5 listed)
- Patients older than 18 years of age;
- Patients who lack completed night and daily diaries;
- Patients with continuous incontinence;
- Patients with neurological disorders and/or signs of spinal occult dysraphism;
- Patients with a severe cognitive disorder.
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
Daily urinary frequency
Time frame: at baseline
increase (≥8 micturitions/day) or decrease (≤3 micturitions/day)
Maximum Voided Volume (MVV)
Time frame: at baseline
volume of urine emitted in 24 hours, excluding first morning urine
Bladder capacity
Time frame: at baseline
reduction (<35% of expected bladder capacity) or increase (> 150% of expected bladder capacity)
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.
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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.
Andrea Pasini, 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 Enuresis, 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 4 inclusion and 5 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: under way, not looking for participants, 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Daily urinary frequency (time frame: at baseline). The study lists 3 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.