Short Interval Versus Long Interval Repeated Extracorporeal Shockwave Lithotripsy (ESWL) for 8-15 mm Renal Stones.

February 11, 2026 updated by: Region Skane

Double Extracorporeal Shockwave Lithotripsy for Renal Stones.

Extracorporeal shockwave lithotripsy (ESWL) is one way to treat renal stones. In this clinical trial our goal is to evaluate if two ESWL the same week is equal good and safe to two ESWL 3 weeks regarding renal stones 8-15 mm.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Detailed Description

All patients with a renal stone 8-15 mm are asked to participate. If they give consent they are randomized to ESWL with an interval of 2 days or 3 weeks. Data regarding age, gender, stone size, Hounsfield unit, skin to stone distance, urine culture, results from the follow up CT and need for auxillary interventions are extraced from the medical records.

Study Type

Interventional

Enrollment (Estimated)

600

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Helsingborg, Sweden
        • Department of Urology
      • Stockholm, Sweden
        • Department of Urology, KI Huddinge

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria: All patients with a renal stone 8-15 mm who are planned for intervention -

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

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: ESWL, two days
Procedure: Extracorporeal shockwave lithotripsy (ESWL)
ESWL, two treatments with an interval of two days or three weeks.
Active Comparator: ESWL, three weeks
Procedure: Extracorporeal shockwave lithotripsy (ESWL)
ESWL, two treatments with an interval of two days or three weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to stone free status
Time Frame: From enrollment until closure
Number of days from the day the treatment starts until the end of follow up.
From enrollment until closure
Complications
Time Frame: From enrollment until closure
Are there any differences in complications
From enrollment until closure
Number of participants considered stone free at follow up
Time Frame: From enrollment until closure.
Number of participants who are stone free at the follow up after two ESWL. Stone status will be assessed with computer tomography.
From enrollment until closure.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Participant´s experiences
Time Frame: From enrollment until closure
Participant´s experiences, quality of life questionnaire. Most questions were structured as yes/ no items or included three to four predefined response options.
From enrollment until closure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Region Skane

Investigators

  • Principal Investigator: Magnus Wagenius, MD, PhD, University of Lund

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 4, 2022

Primary Completion (Estimated)

April 1, 2026

Study Completion (Estimated)

April 1, 2026

Study Registration Dates

First Submitted

January 20, 2026

First Submitted That Met QC Criteria

February 11, 2026

First Posted (Actual)

February 19, 2026

Study Record Updates

Last Update Posted (Actual)

February 19, 2026

Last Update Submitted That Met QC Criteria

February 11, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2022-00035-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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