NCT06815107

Brief Summary

The placement of a Ureteral Double-J Stent as an emergency treatment or preparation for endoscopy after Colic nephritis is very frequent. It is often poorly supported, most often by young patients. A rich symptomatology is related to the probe responsible for a limitation of activities that can have a strong socio-economic impact. The objective of this study is the identification of the predictive factors of poor tolerance.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2020

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 15, 2020

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 15, 2021

Completed
3.8 years until next milestone

First Submitted

Initial submission to the registry

February 4, 2025

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 7, 2025

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2026

Completed
Last Updated

February 7, 2025

Status Verified

January 1, 2025

Enrollment Period

1 year

First QC Date

February 4, 2025

Last Update Submit

February 4, 2025

Conditions

Keywords

Ureteral Double-J Stenttoleranceurinary symptom

Outcome Measures

Primary Outcomes (2)

  • tolerance score of Ureteral Double-J Stent

    A tolerance score of Ureteral Double-J Stent will be established using the USSQ questionnaire allowing the comparison of the symptomatology with and after ablation of the stent

    day 15

  • tolerance score of Ureteral Double-J Stent

    A tolerance score of Ureteral Double-J Stent will be established using the USSQ questionnaire allowing the comparison of the symptomatology with and after ablation of the stent

    3 months

Interventions

On day 1 of an ureteral double J stenting, each participant will receive the first USSQ questionnaire, in the French validated version. This questionnaire will be completed at home, one week after the intervention and returned at the following consultation or hospitalization.

if the stent is removed less than 6 months later, the second USSQ survey, in the French validated version will be given to the patient when removing the stent. This questionnaire will be completed at home one week after removal of the stent and return to the referent hospital. If the patient does not return the second questionnaire, our team may contact them by phone to complete it.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • patient over 18 years old
  • patient who need Ureteral Double-J Stenting

You may not qualify if:

  • patient under 18 years old,
  • Iterative change,
  • understanding disorder,
  • inability to answer the questionnaire,
  • refusal of the patient,
  • long-term Ureteral Double-J Stenting (more than 6 month),
  • active cancer.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Amiens-Picardie

Amiens, 80054, France

RECRUITING

Central Study Contacts

Philippe De Sousa, MD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 4, 2025

First Posted

February 7, 2025

Study Start

April 15, 2020

Primary Completion

April 15, 2021

Study Completion

April 1, 2026

Last Updated

February 7, 2025

Record last verified: 2025-01

Data Sharing

IPD Sharing
Will not share

Locations