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Active, not recruitingNCT06764498Updated Jan 8, 2025

Retrospective Study to Evaluate the Effectiveness of the Approach to Enuresis in Our Center

An observational study in Enuresis, sponsored by IRCCS Azienda Ospedaliero-Universitaria di Bologna. Active, not recruiting at 1 site in Italy. Open to participants aged Up to 17 Years. Per ClinicalTrials.gov, last updated 2025-01-08.

Sponsored by IRCCS Azienda Ospedaliero-Universitaria di Bologna · Observational

From the registry’s dates

  • Primary completion was expected by Dec 2025, 9 months ago, but the record still lists the study as active, not recruiting.
Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
200
Ages
Up to 17 Years
Sex
All
01

Study 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 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.

02

Conditions studied

  • Enuresis

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Keywords

  • Enuresis
  • Children
03

In context

Enuresis

846 studies on the registry are indexed under Enuresis; 79 are open to participants now.

This study's planned enrollment of 200 is above the median of 125 across 162 observational studies indexed under Enuresis.

Browse Enuresis studies →

Lead sponsor

IRCCS Azienda Ospedaliero-Universitaria di Bologna is the lead sponsor of 509 studies on the registry; 285 are open to participants now.

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

04

Who can participate

Ages eligible
Up to 17 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • 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.
05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
200 participants (estimated)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. Daily urinary frequency

    increase (≥8 micturitions/day) or decrease (≤3 micturitions/day)

    Time frame: at baseline

  2. Maximum Voided Volume (MVV)

    volume of urine emitted in 24 hours, excluding first morning urine

    Time frame: at baseline

  3. Bladder capacity

    reduction (\<35% of expected bladder capacity) or increase (\> 150% of expected bladder capacity)

    Time frame: at baseline

07

Study locations

1 site
  • IRCCS Azienda Ospedaliero-Universitaria di Bologna
    Bologna, 40138, Italy
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Feb 2022 (actual). Primary completion is estimated for Dec 2025, 46 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 2, 2025
First posted
Jan 8, 2025
StartActual
Feb 10, 2022
Primary completionEst.
Dec 31, 2025
CompletionEst.
Dec 31, 2025
Last update
Jan 8, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jan 8, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06764498
Responsible party
Sponsor
First posted
Jan 8, 2025
Start date
Feb 10, 2022
Primary completion
Dec 31, 2025 (estimated)
Completion
Dec 31, 2025 (estimated)
Last update
Jan 8, 2025

Study contacts

Andrea Pasini, MD
principal investigator · IRCCS Azienda Ospedaliero-Universitaria di Bologna

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Dec 2024. You cannot join it, but the record below documents what was studied.

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