NCT06092203

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2023

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2023

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

October 10, 2023

Completed
13 days until next milestone

First Posted

Study publicly available on registry

October 23, 2023

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2024

Completed
Last Updated

October 23, 2023

Status Verified

October 1, 2023

Enrollment Period

1.5 years

First QC Date

October 10, 2023

Last Update Submit

October 15, 2023

Conditions

Pediatric ALL

Keywords

UrolithiasisQuality of lifePCNLSWL

Outcome Measures

Primary Outcomes (1)

  • The PedsQL questionnaire

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

    12 months

Study Arms (2)

Patients

Pediatric patients who underwent treatment for utrollithiasis.

Control

Cross-matched group of healthy children.

Eligibility Criteria

Age2 Years - 18 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

All pediatric patients with urolithiasis.

You may qualify if:

  • Patients who had urinary stones

You may not qualify if:

  • Patients presenting with obstructive uropathy or urosepsis.
  • Recent (less than 4 weeks) surgical intervention for urinary stone disease.
  • Indwelling urinary catheters or stents (urethral catheter, ureteral stents or nephrostomy tube).
  • Associated mental illness or cognitive dysfunction.
  • Associated chronic medical illness that may compromise QoL.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Urology and Nephrology Center

Al Mansurah, 35516, Egypt

RECRUITING

MeSH Terms

Conditions

Precursor Cell Lymphoblastic Leukemia-LymphomaUrolithiasis

Condition Hierarchy (Ancestors)

Leukemia, LymphoidLeukemiaNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Study Officials

  • Ahmed R EL-Nahas, MD

    Mansoura University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ahmed R EL-Nahas, MD

CONTACT

+201221136899ar_el_nahas@yahoo.com

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Target Duration
12 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Urology

Study Record Dates

First Submitted

October 10, 2023

First Posted

October 23, 2023

Study Start

February 1, 2023

Primary Completion

August 1, 2024

Study Completion

October 1, 2024

Last Updated

October 23, 2023

Record last verified: 2023-10

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)