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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ESWL, two days | Active Comparator |
| |
| ESWL, three weeks | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Extracorporeal shockwave lithotripsy (ESWL) | Procedure | ESWL, two treatments with an interval of two days or three weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Time to stone free status | Number of days from the day the treatment starts until the end of follow up. | From enrollment until closure |
| Complications | Are there any differences in complications | From enrollment until closure |
| Number of participants considered stone free at follow up | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Participant´s experiences | 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 |
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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.
-
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| Name | Affiliation | Role |
|---|---|---|
| Magnus Wagenius, MD, PhD | University of Lund | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Urology | Helsingborg | Sweden | ||||
| Department of Urology, KI Huddinge |
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| ID | Term |
|---|---|
| D007669 | Kidney Calculi |
| ID | Term |
|---|---|
| D053040 | Nephrolithiasis |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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| ID | Term |
|---|---|
| D008096 | Lithotripsy |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
| D059708 | Ultrasonic Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
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Randomisation to ESWL with an interval of two days and with an interval of three weeks.
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| Stockholm |
| Sweden |
| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052878 | Urolithiasis |
| D014545 | Urinary Calculi |
| D052801 | Male Urogenital Diseases |
| D002137 | Calculi |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |