Treatment for small ureteric stones using medication

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

This study is testing if a medication called silodosin can help adults with small stones in their ureters pass them more easily without needing surgery.

Quick facts

• Phase: Phase 4
• Study type: Interventional
• Enrollment: 240 (estimated)
• Ages: 18 Years to 70 Years
• Sex: All
• Sponsor: Getz Pharma (Industry-sponsored)
• Locations: 1 site (Peshawar, KPK)
• Trial ID: NCT05977647 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the use of α-blockers, specifically silodosin, as a medical expulsive therapy (MET) for patients with distal ureteric stones (DUS) located in the lower third of the ureter. The study aims to confirm the efficacy and safety of this non-invasive treatment option compared to traditional invasive procedures. Participants will be adults aged 18 to 70 with specific eligibility criteria, including the presence of a single, unilateral, radiopaque ureteral calculus. The trial will assess the therapeutic benefits of α-blockers, which have shown promising results in previous studies.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18 to 70 with a single, unilateral ureteral stone located in the distal third of the ureter.

Not a fit: Patients with existing renal stones in other locations, severe hydronephrosis, or those currently taking α-blockers may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a safer and less invasive option for patients suffering from ureteric stones, potentially reducing the need for surgical interventions.

How similar studies have performed: Previous studies have shown significant therapeutic benefits of α-blockers for treating distal ureteric stones, indicating a promising approach.

Eligibility criteria

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)

Where this trial is running

Peshawar, KPK

• North west general hospital — Peshawar, Kpk, Pakistan (Recruiting)

Study contacts

• Principal investigator: Salman El Khalid, MBBS — The Kidney Centre
• Study coordinator: Dr. Mahaveer N Maheshwari, MBBS

Conditions Ureteric Stone of Lower Third of Ureter