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

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

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2023/06/054090
Enrollment
86
Registered
2023-06-19
Start date
Unknown
Completion date
Unknown
Last updated
2024-01-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: N201- Calculus of ureter

Interventions

Intervention1: Tamsulosin in Combination with Tadalafil: Tamsulosin 0.4mg Tadalafil 10 mg Control Intervention1: oral Silodosin 8mg once daily for 1 month: oral Silodosin 8mg once daily for 1 month

Sponsors

Sun Pharma
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patients aged 18 years or above with distal ureteric calculi 2. Written informed consent.

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
a)stone expulsion time b)number of pain episodes c)frequency of hospital visits Side effects of drugs usedTimepoint: 1 month

Countries

India

Contacts

Public ContactPrasanna Ram

AIIMS, Bhubaneswar

dr.praspr@gmail.com9686559576

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026