Follow-Up of Ureteral Stones ≤4 mm

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

Status

Enrolling by invitation

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07176026

Enrollment

1600

Registered

2025-09-16

Start date

2025-02-01

Completion date

2027-01-01

Last updated

2025-09-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Kidney Stone

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.	—

Countries

Sweden

Outcome results