Health Condition 1: N201- Calculus of ureter
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: A. Written informed consent. B. Age more than or equal to 18 years. C. Newly diagnosed, single, unilateral, ureteral calculus diagnosed on non-contrast computed tomography. D. Stone size less than or equal to 10 mm.
Exclusion criteria
Exclusion criteria: A. Fever, defined as axillary temperature 100�° F or more, or a history of fever with chills and rigors. B. Ipsilateral renal angle tenderness on examination, or a bulky ipsilateral kidney with peri-renal fat stranding on non-contrast computed tomography suspicious of acute pyelonephritis. C. Active urinary tract infection (UTI) as confirmed on urine culture. D. Presence of synchronous ipsilateral renal pelvic and pelvic-ureteral junction stone, or bilateral ureteral calculi. E. Any previous intervention for the present calculus, including shock-wave lithotripsy (SWL), ureteroscopy (URS), ureteral stent placement, or percutaneous nephrostomy (PCN). F. Ureteral stone in an ectopic or malrotated kidney. G. Deranged renal parameters. H. Patients with a solitary kidney. I. Pregnancy. J. Immune-compromised state, including acquired immune-deficiency disease, immune-suppressant therapy, chemotherapy, and long-term steroid therapy. K. Not available for follow-up.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Spontaneous stone passage (SSP) rate, as confirmed by a low-dose non-contrast computed tomography, in patients with ureteral calculus receiving medical expulsive therapy (MET).Timepoint: 4 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Sensitivity and specificity of patient-reported outcomes in predicting spontaneous stone passage (SSP).Timepoint: 4 weeks;Symptom-resolution rate in patients with successful SSP for each presenting symptom (questionnaire-based).Timepoint: At 4 weeks and at 3 months;Ureteral stricture rate as confirmed by the presence of hydroureteronephrosis (HUN) on an ultrasound, in patients with large (more than five mm), obstructing (presence of HUN) ureteral calculus, at three months after successful SSP.Timepoint: 3 months | — |
Countries
India
Contacts
AIIMS Bhubaneswar