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Elattar: Quality of Life for Pediatric Urolithiasis

Sponsor
Mansoura University (Other)
Overall Status
Recruiting
CT.gov ID
NCT06092203
Collaborator
(none)
100
Enrollment
1
Location
20
Anticipated Duration (Months)
5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The aim of this study is to assess the quality of life (QoL) in pediatric patients with urinary stone disease.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    This study will assess the quality of life (QoL) in pediatric patients with urinary stone disease using the pediatric quality of life (PedsQol) questionnaire in comparison to normal healthy age/sex matched population.

    Study Design

    Study Type:
    Observational [Patient Registry]
    Anticipated Enrollment :
    100 participants
    Observational Model:
    Case-Control
    Time Perspective:
    Prospective
    Official Title:
    Assessment of Health-Related Quality of Life for Pediatric Patients With Urinary Stone Disease.
    Actual Study Start Date :
    Feb 1, 2023
    Anticipated Primary Completion Date :
    Aug 1, 2024
    Anticipated Study Completion Date :
    Oct 1, 2024

    Arms and Interventions

    Arm Intervention/Treatment
    Patients

    Pediatric patients who underwent treatment for utrollithiasis.
    Control

    Cross-matched group of healthy children.

    Outcome Measures

    Primary Outcome Measures

    1. The PedsQL questionnaire [12 months]

      comparison of overall PedsQL score between pediatric urolithiasis patients and normal healthy age/sex matched population.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    2 Years to 18 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    • Patients who had urinary stones
    Exclusion Criteria:

    1. Patients presenting with obstructive uropathy or urosepsis.

    2. Recent (less than 4 weeks) surgical intervention for urinary stone disease.

    3. Indwelling urinary catheters or stents (urethral catheter, ureteral stents or nephrostomy tube).

    4. Associated mental illness or cognitive dysfunction.

    5. Associated chronic medical illness that may compromise QoL.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Urology and Nephrology Center Mansoura Egypt 35516

    Sponsors and Collaborators

    • Mansoura University

    Investigators

    • Principal Investigator: Ahmed R EL-Nahas, MD, Mansoura University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Ahmed R. EL-Nahas, Professor of Urology, Mansoura University
    ClinicalTrials.gov Identifier:
    NCT06092203
    Other Study ID Numbers:
    • 2278
    First Posted:
    Oct 23, 2023
    Last Update Posted:
    Oct 23, 2023
    Last Verified:
    Oct 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Ahmed R. EL-Nahas, Professor of Urology, Mansoura University
    Urolithiasis
    Quality of life
    PCNL
    SWL
    Additional relevant MeSH terms:
    Urolithiasis

    Study Results

    No Results Posted as of Oct 23, 2023