Medical Stone Expulsive Therapy for Acutely Obstructed Ureteric Calculi

Launched by GETZ PHARMA · Aug 3, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a medication called silodosin to see if it can help patients with small stones located in the lower part of the ureter, which is the tube that carries urine from the kidney to the bladder. Instead of undergoing surgery, this study is exploring whether taking silodosin can help these stones pass more easily. This is important because many doctors are now recommending medications as a first option for treating these types of stones.

To participate in this trial, you need to be an adult between 18 and 70 years old and have a specific type of stone that measures between 5 to 10 mm in size. You'll also need to be able to drink fluids and take oral pain medication. However, some people may not qualify, such as those who have other kidney stones, signs of infection, or certain health conditions. If you join the trial, you will receive the medication and be monitored regularly to see how well it works for you. Overall, this study aims to gather more information about silodosin's safety and effectiveness for treating ureteric stones.

Gender

ALL

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)