Efficacy of Flomax to Improve Stone Passage Following Shock Wave Lithotripsy

N/ATerminatedNCT00209131

Emory University24 enrolled

Overview

The majority of kidney stones are treated with shock wave lithotripsy (SWL). We are examining if the medication Flomax will result in improved stone passage rates following SWL.

Placebo blinded study examining the effects of Flomax on stone passage rates following SWL.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Urolithiasis

Interventions

FlomaxDRUG

0.4mg Flomax pills will be given to patients to take once daily for one month following shock wave lithotripsy to aid the stone passage.

Sugar pillDRUG

Comparable sugar pills will be given to the placebo group to take daily for one month following shock wave lithotripsy to aid stone passage.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patients 18 years old and above with urolithiasis scheduled for shock wave lithotripsy. Exclusion Criteria: * Contraindications to Flomax * Patients with renal impairment (serum creatinine above 2.0) * Patients with hepatic impairment (liver enzymes 2.5 times the upper limit of normal) * Use of other oral alpha blockers

Locations (1)

Emory University

Atlanta, Georgia, United States

Outcomes

Primary Outcomes

Time to Passage of Stone Fragments

Time to passage of stone fragments following shock wave lithotripsy as documented by patient diaries and follow-up radiographic imaging.

Time frame: 2 weeks and 3 months

Secondary Outcomes

Medical Evaluation

Evaluation of pain assessments, lower urinary tract symptoms, side effects of study medication and need for hospitalizations and additional endoscopic procedures.

Time frame: 2 weeks and 3 months

Data from ClinicalTrials.gov

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