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Silodosin alone versus Tamsulosin with Tadalafil as medical expulsive therapy for distal ureteric stones: A Prospective Randomized Trial.

Phase 3
Conditions
Health Condition 1: N201- Calculus of ureter
Registration Number
CTRI/2023/06/054090
Lead Sponsor
Sun Pharma
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Open to Recruitment
Sex
Not specified
Target Recruitment
0
Inclusion Criteria

1. Patients aged 18 years or above with distal ureteric calculi

2. Written informed consent.

Exclusion Criteria

1.Patients with proximal ureteric calculi

2.Patients with multiple renal calculi

3.Patients with staghorn calculi

4.Patients with renal or ureteric anomalies

5.Pregnant women

6.Patients on calcium channel blockers or nitrate therapy for cardiac diseases

7.Patient’s with postural hypotension

8.Patients with a past history of floppy iris syndrome

9.Patient with fever more than 37.8ºC

10.Patients with a GFR =30

11.Patients with a history of ureteral surgery

12.Patients with known drug allergies

13.Patients in need of surgical or endoscopic intervention

14.Patients with uremic symptoms

15.Patients with diabetes, peptic ulcer or on concomitant treatment with b-blockers

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
To see the rate of stone expulsion after 1 month of therapy.Timepoint: To see the rate of stone expulsion after 1 month of therapy.
Secondary Outcome Measures
NameTimeMethod
a)stone expulsion time <br/ ><br>b)number of pain episodes <br/ ><br>c)frequency of hospital visits <br/ ><br>Side effects of drugs usedTimepoint: 1 month
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