ToleranceToleJJNCT06815107
Risk Factors for Poor Tolerance of Ureteral Double-J Stent
A study testing questionnary and USSQ survey in people with Tolerance and Ureteral Double-J Stent, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tolerance, Ureteral Double-J Stent, Urinary Symptoms
- What is being tested?
- questionnary and USSQ survey
- How many people
- 200 participants
- Where
- 1 siteFrance
- Study dates
- 15 Apr 2020to Apr 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patient over 18 years old
- patient who need Ureteral Double-J Stenting
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
CHU Amiens-Picardie
Amiens, 80054
Philippe De Sousa, MD, 33+322455775, desousa.philippe@chu-amiens.fr
About this study
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.
- Conditions
- Tolerance, Ureteral Double-J Stent, Urinary Symptoms
- Being tested
- questionnary, USSQ survey
- Keywords
- Ureteral Double-J Stent, tolerance, urinary symptom
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
questionnaryOther
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.
USSQ surveyOther
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2025
- Study start15 Apr 2020
- Primary completion15 Apr 2021
- Study completionApr 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ToleranceStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire, AmiensThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire, Amiens
- Sponsor type
- University, hospital or other
- Collaborators
- Centre Hospitalier d'Abbeville, Centre Hospitalier Intercommunal de Compiègne-Noyon, University Hospital, Caen
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06815107
- Sponsor's protocol ID
- PI2020_843_0029
- Acronym
- ToleJJ
- Status last verified
- Sep 2026
- First submitted
- 4 Feb 2025
- Last updated
- 4 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Risk Factors for Poor Tolerance of Ureteral Double-J Stent
- ClinicalTrials.gov ID
- NCT06815107
- Acronym / sponsor ID
- ToleJJ / PI2020_843_0029
- Conditions
- Tolerance, Ureteral Double-J Stent, Urinary Symptoms
- Keywords
- Ureteral Double-J Stent, tolerance, urinary symptom
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire, AmiensUniversity, hospital or other
- Collaborators
- Centre Hospitalier d'Abbeville, Centre Hospitalier Intercommunal de Compiègne-Noyon, University Hospital, Caen
- Study start
- 15 Apr 2020 (actual)
- Primary completion
- 15 Apr 2021 (actual)
- Study completion
- Apr 2030 (estimated)
- First posted
- 7 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- patient over 18 years old
- patient who need Ureteral Double-J Stenting
Key exclusion criteria (7 listed)
- patient under 18 years old,
- Iterative change,
- understanding disorder,
- inability to answer the questionnaire,
- refusal of the patient,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| questionnaryOn 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. | Other | – |
| USSQ surveyif 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. | Other | – |
Primary outcome
tolerance score of Ureteral Double-J Stent
Time frame: day 15
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
tolerance score of Ureteral Double-J Stent
Time frame: 3 months
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing questionnary and USSQ survey in people with Tolerance and Ureteral Double-J Stent, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Philippe De Sousa, MD (33+322455775, desousa.philippe@chu-amiens.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
tolerance score of Ureteral Double-J Stent (time frame: day 15). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Sep 2026.