Comparison between tamsulosin and silodosin in terms of benefits and safety in patients with lower ureteric calculus of size less than or equal to size 10 mm.

Not yet recruiting

• Conditions: Calculus of ureter,

• Registration Number: CTRI/2021/08/035595
• Lead Sponsor: Arvind Kumar Prabhat

Brief Summary

To compare the efficacy and safety of tamsulosin and silodosin among the subjects with distal ureteric calculus of size less than or equal to 10 mm -

1) Medical expulsion therapy in distal ureteic calculus.

2) Time taken for expulsion of the calculus.

3) Analgesic requirement.

4) Rate of failure of spontaneous distal ureteric calculus expulsion on medical expulsion therapy and need of surgical intervention.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-08-21
• Last Update Posted: 2021-10-08

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• 1. All adult subjects coming to Urology OPD with ureteric colic.
• 2. Unilateral single distal ureteric calculus of size ≤ 10 mm diagnosed on CTKUB plain.
• 3. Subjects with prior informed consent.

Exclusion Criteria

• 1. Subjects who do not want to undergo medical expulsion therapy (MET) and want immediate surgical management.
• 2. Breastfed and Pregnant women.
• 3. Subjects with congenital anomalies of genitourinary and gastrointestinal tract.
• 3. Subjects with fever.
• 4. Subjects with impaired renal function.
• 5. Subjects in ICU with urinary sepsis.
• 6. Lower ureteric calculi size > 10 mm.
• 9. Calculus in single functioning kidney (SFK).
• 10. Subjects on hemodialysis.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Which drug ( Tamsulosin or Silodosin) has more efficacy and safety in patients with distal ureteric calculus of size less than or equal to 10 mm	Effect of Medical expulsion therapy ( Tamsulosin or Silodosin ) in terms of expulsion of calculus in patients with distal ureteric calculus of size equal to or less than 10 mm over a duration of 7 days.

Secondary Outcome Measures

Name	Time	Method
To know efficacy and safety of tamsulosin and silodosin as a medical expulsion therapy in patients with distal ureteric calculus of size equal to or less than 10 mm.	Total duration of study - 1 year 6 months

Trial Locations

Locations (1)

Dr Pinnamaneni Siddhartha institute of medical sciences and research foundation; 🇮🇳 Krishna, ANDHRA PRADESH, India

Dr Pinnamaneni Siddhartha institute of medical sciences and research foundation

🇮🇳Krishna, ANDHRA PRADESH, India

Arvind Kumar Prabhat

Principal investigator

9075631360

pmttarget@gmail.com