Follow-Up of Ureteral Stones ≤4 mm

NCT07176026 | Enrolling By Invitation

• 1 other identifier: 2024-04897-01
• Study Type: observational
• Target: 1,600
• Locations: 1 country
• Sites: 2

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.

Conditions

Kidney Stone

Outcome Measures

Primary Outcomes (2)

• 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

  Residual pain is measured with VAS (visual analogue scale), values 0-10. VAS 0 = no pain and VAS 10 = worst possible pain.

  From enrolement to passage of the stone or maximum 8 weeks.

Secondary Outcomes (2)

• QoL form including sick leave and return to full ADL

  From enrolement to passage of the stone or maximum 8 weeks.

• 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.

Study Arms (1)

Follow-up with S-creatine, questionnaire and CT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All patients with acute renal colic where a CT within 24 hours shows a ureteral stone ≤ 4mm.

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Region Skane: lead

Study Sites (2)

Department of Urology

Helsingborg, Sweden

Location

Department of Urology, KI Huddinge

Stockholm, Sweden

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

S-creatinine, blood test.

MeSH Terms

Conditions

Kidney Calculi

Condition Hierarchy (Ancestors)

Nephrolithiasis; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urolithiasis; Urinary Calculi; Male Urogenital Diseases; Calculi; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Magnus Wagenius, PhD

  University of Lund

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 8 Weeks
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 3, 2025
• First Posted: September 16, 2025
• Study Start: February 1, 2025
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2027
• Last Updated: September 16, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

SE (2)