Medical Stone Expulsive Therapy for Acutely Obstructed Ureteric Calculi (NCT05977647) | Clinical Trial Compass
CompletedPhase 4
Medical Stone Expulsive Therapy for Acutely Obstructed Ureteric Calculi
Pakistan240 participantsStarted 2024-09-01
Plain-language summary
As a first treatment option for small-size ureteric stones, α-blockers are now being used for medical expulsive therapy (MET) instead of invasive procedures. There is high evidence of the therapeutic benefit of α-blockers in the treatment of Distal ureteric stone (DUS); also endorsed by international guidelines.
However, limited data is available worldwide, on the effect of silodosin to treat DUS. A multi-center study is needed to confirm the efficacy and safety of therapy.
Who can participate
Age range18 Years ā 70 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Adults male and female aged 18 to 70 years
* Patients who give informed consent
* Stone located in the distal 1/3rd of ureter (Single, unilateral and radiopaque ureteral calculus 5 to 10 mm visible on the CT-KUB± X-ray KUB within the ureter
* Serum creatinine level within the normal range (adult men, 0.74 to 1.35 mg/dL \& 0.59 to 1.04 mg/dL)
* Ability to tolerate oral fluids and oral pain medication
Exclusion Criteria:
* Patients already taking an alpha-adrenergic antagonist medication for 4 weeks
* Evidence of any other renal stone simultaneously present or at any location
* Hydronephrosis Grade 3 (Moderate) \& Grade 4 (Severe) Patients with eGFR \<60 ml/min/1.73m2
* Signs of infection including temperature \>38ĀŗC or Urinalysis with any of the following: Positive Leukocyte Esterase, Positive Nitrates, or White Blood Cell Count \>5/hfp in the setting of a positive urine culture (defined as a single isolated bacterial species population of \>100,000 CFU)
* Patients with chronic pain already undergoing treatment with narcotic medications or drug abusers
* Pregnant or lactating women
* Patient suffering from urinary tract infection, ureteral surgery, and existing DJ stents.
* Clinical jaundice
* Any forms of anatomical obstructions in the urinary tract
* The previously suffering from postural hypotension
* Any other disease jeopardizing participation in trial and could lead to increase patient health risks
* History of allergic reactions with the study dā¦