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

NCT06764498 | Active Not Recruiting

• 1 other identifier: ENU-PED-21-02
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

Retrospective study to evaluate the effectiveness of the approach to enuresis at IRCCS Azienda Ospedaliero-Universitaria of Bologna Policlinico di Sant'Orsola, Italy.

Conditions

Enuresis

Keywords

Enuresis; Children

Outcome Measures

Primary Outcomes (3)

• Daily urinary frequency

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

  at baseline

• Maximum Voided Volume (MVV)

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

  at baseline

• Bladder capacity

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

  at baseline

Eligibility Criteria

• Age: Up to 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• IRCCS Azienda Ospedaliero-Universitaria di Bologna: lead

Study Sites (1)

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Bologna, 40138, Italy

Location

MeSH Terms

Conditions

Enuresis

Condition Hierarchy (Ancestors)

Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Behavioral Symptoms; Behavior; Elimination Disorders; Mental Disorders

Study Officials

• Andrea Pasini, MD

  IRCCS Azienda Ospedaliero-Universitaria di Bologna

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 2, 2025
• First Posted: January 8, 2025
• Study Start: February 10, 2022
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: January 8, 2025

Record last verified: 2024-12

Locations

IT (1)