Status:
COMPLETED
Medical Stone Expulsive Therapy for Acutely Obstructed Ureteric Calculi
Lead Sponsor:
Getz Pharma
Conditions:
Ureteric Stone of Lower Third of Ureter
Eligibility:
All Genders
18-70 years
Phase:
PHASE4
Brief 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 ...
Detailed Description
A kidney stone is a crystal formed inside the kidney. It is one of the commonest conditions of kidney disease affecting 12% of the world's population. Out of 12% Ureteric stones, around 20% represent ...
Eligibility Criteria
Inclusion
- 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
- 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 \>38ºC 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 drugs (Silodosin or Tamsulosin)
Key Trial Info
Start Date :
September 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 30 2025
Estimated Enrollment :
240 Patients enrolled
Trial Details
Trial ID
NCT05977647
Start Date
September 1 2024
End Date
June 30 2025
Last Update
August 20 2025
Active Locations (1)
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1
North west general hospital
Peshawar, KPK, Pakistan