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Enrolling by Invitation

NCT Number: NCT07176026

Follow-Up of Ureteral Stones ≤4 mm

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Urology, Helsingborg, Sweden

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Number of ureteral stones ≤ 4mm that pass spontaneously

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

  2. Number of participants with residual pain

    Time frame: 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 outcomes

  1. QoL form including sick leave and return to full ADL

    Time frame: 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.

  2. Proportion of ureteral stone that have passed according to anatomical localisation, S-creatinine and presence of hydronephrosis.

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

Sponsors and collaborators

Lead sponsor

Region Skane

Other

Registry information

Official study title

Follow-Up of Ureteral Stones ≤4 mm: Evaluate the Proportion of Spontaneous Passage and Assess if Symptoms and Stone Characteristics Can Predict Stone Passage

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Sep 16, 2025
Registry last updated
Sep 16, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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