Follow-Up of Ureteral Stones ≤4 mm

• Conditions: Kidney Stone

• Registration Number: NCT07176026
• Lead Sponsor: Region Skane

Brief Summary

The goal of this clinical trial is to evaluate the proportion of ureteral stones ≤4 mm that pass spontaneously within 4 and 8 weeks and assess if pain, blood test (S-creatinine), stone size, stone location and hydronephrosis can predict stone passage. The participants will be asked to fill in a questionare regarding symptoms, give a blood test and undergo a follow-up computed tomography.

Detailed Description

All patients with a diagnosis of ureteral stone ≤4 mm at the Emergency Department in Helsingborg will be asked to participate. If they give consent data regarding age, gender, stone size, stone location, hydronephrosis, S-creatinine, treatments and results from the follow up CT is extraced from the medical records.

Study Timeline

• Study Start: 2025-02-01
• Study First Submitted: 2025-06-03
• Status Verified: 2025-09
• Study First Submitted QC: 2025-09-09
• Last Update Submitted: 2025-09-09
• Study First Posted: 2025-09-16
• Last Update Posted: 2025-09-16
• Primary Completion: 2027-01-01
• Study Completion: 2027-01-01

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 1600

Inclusion Criteria

• all patients with acute renal colic where a CT within 24 hours shows an ureteral stone ≤ 4mm and there is no need for acute intervention.

Exclusion Criteria

• Those who decline to participate, those who are put under guardianship or is less than 18 years old.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of ureteral stones ≤ 4mm that pass spontaneously	From enrolement to passage of the stone or maximum 8 weeks.
Number of participants with residual pain	From enrolement to passage of the stone or maximum 8 weeks.	Residual pain is measured with VAS (visual analogue scale), values 0-10. VAS 0 = no pain and VAS 10 = worst possible pain.

Secondary Outcome Measures

Name	Time	Method
QoL form including sick leave and return to full ADL	From enrolement to passage of the stone or maximum 8 weeks.	Questionnaire specifically designed for this study, including questions about pain (regarding pain: how often, how severe/ VAS, need for pain medication) and the ability/ inability to work as usual. VAS: visual analougus scale 0-10, 0 = no pain and 10 = worst possible pain.
Proportion of ureteral stone that have passed according to anatomical localisation, S-creatinine and presence of hydronephrosis.	From enrolement to passage of the stone or maximum 8 weeks.

Trial Locations

Locations (2)

Department of Urology; 🇸🇪 Helsingborg, Sweden

Department of Urology, KI Huddinge; 🇸🇪 Stockholm, Sweden