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
Retrospective study to evaluate the effectiveness of the approach to enuresis at IRCCS Azienda Ospedaliero-Universitaria of Bologna Policlinico di Sant'Orsola, Italy.
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.
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 →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.
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.
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Exclusion Criteria:
Daily urinary frequency
increase (≥8 micturitions/day) or decrease (≤3 micturitions/day)
Time frame: at baseline
Maximum Voided Volume (MVV)
volume of urine emitted in 24 hours, excluding first morning urine
Time frame: at baseline
Bladder capacity
reduction (\<35% of expected bladder capacity) or increase (\> 150% of expected bladder capacity)
Time frame: at baseline
Started Feb 2022 (actual). Primary completion is estimated for Dec 2025, 46 months after the start.
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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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