Urolithiasis
Conditions
Interventions
Group 1: Ureterorenoscopy and percutaneous nephrolithotripsy
Group 2: Extracorporeal shock wave lithotripsy
Sponsors
Universitätsklinikum Freiburg, Klinik für Urologie
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Urinary stones = 20 mm in all locations of the upper urinary tract requiring treatment. [Renal calcifications/calculi not intended for treatment may be present (e.g. a 2 mm renal papillary calcification/ caliceal stone in a patient intended for treatment of a ureteral stone)] 2. Age = 18 years without an upper age limit 3. Written informed consent obtained according to international guidelines and local laws 4. Ability to understand the nature of the trial and the trial related procedures and to comply with them 5. Sufficient knowledge of the German language to understand both the informed consent and the questionnaires as used in this trial
Exclusion criteria
Exclusion criteria: 1. Multiple stones requiring treatment at the intended site of treatment 2. Patients with stones not suitable for either treatment modality. This may include the following reasons: • Stone not detectable by the imaging mode of the SWL machine in a particular participating center (plain radiography [kidney, ureter, and bladder, KUB], intravenous pyelography, fluoroscopy or sonography). • Anatomical obstruction distal to the stone. • Malformation of the urinary tract potentially affecting stone clearance/ access to the urinary tract, e.g. horseshoe-kidney, megaureter or urinary diversion, e.g. ileum-conduit. • Caliceal diverticular stone. • Arterial aneurysm in the vicinity of the stone. • BMI > 30 kg/m2 3. Malignant tumour of the kidney or ureter 4. Transplant-kidney 5. Untreated or recurrent urinary tract infection 6. Known coagulation dysfunction or taking anticoagulants or platelet inhibitors other than acetylsalicylic acid 7. Chronic or active infection of any kind, acute arterial hypertension or any other serious uncontrolled medical disorders 8. Previous participation (randomisation) in this trial (ipsilateral side), except patients with a second stone on the contralateral side may be included > 1 month after final examination of the primary side 9. Simultaneous participation in other interventional trials which could interfere with this trial; simultaneous participation in registry and diagnostic trials is allowed 10. Known or persistent abuse of medication, drugs or alcohol 11. Person who is in a relationship of dependence/employment with the coordinating investigator or the investigator 12. Planned blood donation during participation in the study 13. Planned pregnancy or current pregnancy at time of enrolment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| -stone clearance within 3 months after randomization -score based on the Comprehensive Complication Index (CCI) from surgery to end of study | — |
Secondary
| Measure | Time frame |
|---|---|
| -stone clearance or small residual fragments (SRF = 4mm) within 3 months after randomization -number of re-treatments and ancillary procedures to achieve a stone-free status at month 3 -score based on the Freiburg Index of Patient Satisfaction (FIPS) at month 3 -scores based on the WISQOL questionnaire (at screening and month 3) | — |
Countries
Germany
Contacts
Public ContactAntonia Elsässer
Universitätsklinikum Freiburg, Klinik für Urologie
Outcome results
None listed