Comparison of Silodosin Versus Tamsulosin on Passage of Acutely Obstructing Ureteral Calculi (History of Last 4 Weeks) in Medical Expulsive Therapy

GTZ-MSE-001-23

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.

2023-10-01

2024-09-30

2024-12-31

Not yet recruiting

Early phase I

240

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 \>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)

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Participants will be randomized into two groups.\n\n1. A permuted block randomization technique will be used\n2. A block represents a separate center/site of enrollment.\n3. There will be 19 recruitment centers\n4. Each center will enroll total 20-25 subjects', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 240, 'type': 'ESTIMATED'}}

2023-08-04