Efficacy and Safety of Silodosin in the Treatment of Natural Expulsion in Patients With Ureteral Stones

• Status: Completed
• Trial end date: 2012-08-01
• Target enrollment: 0
• Participant gender: All

Summary

A lower ureteral calculus, which measures 5 millimeters and less, may be easily expelled by symptomatic therapy. Actually, it has about a 50% chance of successful expulsion.

However, a complication such as urinary tract infection or hydronephrosis or persistent pain may occur before it is expelled. Thus, it is imperative to minimize the occurrence of complications in the process of expectant treatment and also to reduce the time required to expel calculi.

Pharmacotherapy is to relieve ureteral obstruction and thus to expel urinary calculi easily.

This clinical trial is to evaluate the efficacy of silodosin, a selective α1A-blocker, on calculous expulsion in expectant treatment for patients with lower and mid ureteral calculi.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: JW Pharmaceutical
• Treatments: Silodosin

Criteria

Inclusion Criteria:

• Males or female patients aged 20 and over

• Patients having ureteral calculi located mid or lower ureter on abdominal radiograms or excretory urograms or non-enhanced computed tomograms.

• Patients whose calculi measure 10 millimeters and less.

• Patients who voluntarily decided to take part in this clinical trial and gave written consent.

Exclusion Criteria:

• Patients who do not want to undergo expectant treatment

• Female patients who are pregnant or nursing

• Patients with febrile urinary tract infection or severe hydronephrosis or ulcerative diseases or hypotension.

• Patients with severe hepatic dysfunction(e.g. hepatic failure, hepatic cirrhosis, icterus, hepatoma)

• Patients who take α-blocker or α/β-blockers or calcium-channel blockers or steroid drugs

• Patients with multiple ureteral calculi

• Patients whose urinary tracts are anatomically deformed or stenosed

• Patients who underwent invasive operations on their ureters before

• Patients whose blood creatinine levels are 2mg/dL and over

• Patients who are hypersensitive to silodosin

• Patients who take part in clinical trials other than this one

• Patients judged to be inappropriate for this clinical trial by investigators