CClinicalTrials.gg
Enrolling by invitationNCT07176026Updated Sep 16, 2025

Follow-Up of Ureteral Stones ≤4 mm

An observational study in Kidney Stone, sponsored by Region Skane. Enrolling by invitation at 2 sites in Sweden. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-09-16.

Sponsored by Region Skane · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
1,600
Ages
18 Years and older
Sex
All
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Study 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.

Read the 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.

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Conditions studied

  • Kidney Stone

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03

In context

Kidney Calculi

598 studies on the registry are indexed under Kidney Calculi; 163 are open to participants now.

This study's planned enrollment of 1,600 is above the median of 144 across 110 observational studies indexed under Kidney Calculi.

Browse Kidney Calculi studies →

Lead sponsor

Region Skane is the lead sponsor of 372 studies on the registry; 113 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

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

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

Exclusion Criteria:

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

Observational model
Cohort
Time perspective
Prospective
Enrollment
1,600 participants (estimated)
Target follow-up
8 Weeks
Patient registry
Yes
Biospecimen retention
Samples without dna

Groups and cohorts

  • Follow-up with S-creatine, questionnaire and CT
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What researchers measure

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

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

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

Secondary outcomes

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

    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.

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

  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.

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Study locations

2 sites
  • Department of Urology
    Helsingborg, Sweden
  • Department of Urology, KI Huddinge
    Stockholm, Sweden
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 16, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT07176026
Lead sponsor
Region Skane
Responsible party
Sponsor
First posted
Sep 16, 2025
Start date
Feb 1, 2025
Primary completion
Jan 1, 2027 (estimated)
Completion
Jan 1, 2027 (estimated)
Last update
Sep 16, 2025

Study contacts

Magnus Wagenius, PhD
principal investigator · University of Lund

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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