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Ureteric Stone of Lower Third of Ureter

Medical Stone Expulsive Therapy for Acutely Obstructed Ureteric Calculi

Sponsored by Getz Pharma

About this trial

Last updated 2 years ago

Study ID

GTZ-MSE-001-23

Status

Not yet recruiting

Type

Interventional

Phase

Phase 4

Placebo

No

Accepting

18-75 Years
18 to 70 Years
All
All

Trial Timing

Ended 8 months ago

What is this trial about?

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.

What are the participation requirements?

Yes

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

No

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)