N20.9
Conditions
Interventions
Group 1: Part 1: Ureteral calculi: (flexible) uretherrenoscopy (f)URS (experimental)
Part 2a: Renal calculi = 10 mm (non-lower pole): (flexible) uretherrenoscopy (f)URS (experimental)
Part 2b: Renal c
Sponsors
Universitätsklinikum Freiburg, Klinik für Urologie
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Urolithiasis of upper urinary tract (single urinary stone = 20 mm) requiring treatment
Exclusion criteria
Exclusion criteria: - Multiple stones at the intended site of treatment - Renal stones > 20 mm - Stone not detectable as required for imaging mode of the respective SWL machine in the participating centre (plain radiography (KUB), intravenous ureteropyelography, flouroscopy or sonography) - Stones with medium density > 1000 HU on NCCT - Caliceal diverticular stone - Papillary calcifications (which might be mistaken for residual fragments in final CT) - Malformation of the kidney or ureter, e.g. horseshoe-kidney, megaureter - Anatomical obstruction distal to the stone - Malignant tumour of the kidney or ureter - Transplant-kidney - Untreated or recurrent urinary tract infection - Known coagulation dysfunction or anticoagulation or platelet inhibitors other than acetylsalicylic acid - Chronic or active infection of any kind, acute arterial hypertension or any other serious uncontrolled medical disorders - Arterial aneurysm in the vicinity of the stone - Age < 18 years - Current or planned pregnancy, nursing period - Patient without legal capacity who is unable to understand the nature, significance and consequences of the study - Previous participation (randomization) in this study - Participation in another interventional clinical trial within the last thirty days before the start of this study - Simultaneous participation in other interventional trials which could interfere with the trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Recruitment / randomisation rate | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) Feasibility 2) Stone clearance (CT-controlled) within 3 months (yes, no) 3) Clinical success (stone clearance or CIRF = 4 mm) within 3 months (yes, no) 4) Number of re-treatments of the same modality to achieve stone free status during the 3 months-treatment period (until final control after 3 months) 5) Ancillary procedures 6) Efficiency quotient 7) Operative data (use of anaesthesia, operating time (for primary treatment only)) 8) Postoperative data (hospital stays (days, for primary treatment only), number of consultations 9) Use of analgetics (CACS) 10) Patient satisfaction | — |
Countries
Germany
Contacts
Public ContactMartin Schönthaler
Universitätsklinikum Freiburg, Klinik für Urologie
Outcome results
None listed