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Reliability of patients in announcing the success of medical treatment of stones in ureter.

Medical Expulsive Therapy (MET) in adults with ureteral calculi: a prospective evaluation of patient-reported outcomes.

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2020/10/028777
Enrollment
163
Registered
2020-10-29
Start date
Unknown
Completion date
Unknown
Last updated
2022-10-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: N201- Calculus of ureter

Interventions

Intervention1: NIL: NIL

Sponsors

AIIMS Bhubaneswar
Lead Sponsor

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

MeasureTime 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

MeasureTime 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

Public ContactAbhishek Pandey

AIIMS Bhubaneswar

abhimsbhu@gmail.com7528947691

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 11, 2026