Efficacy of Flomax to Improve Stone Passage Following Shock Wave Lithotripsy

Not Applicable

Terminated

• Conditions: Urolithiasis
• Interventions: Drug: Flomax; Drug: Sugar pill

• Registration Number: NCT00209131
• Lead Sponsor: Emory University

Brief Summary

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.

Detailed Description

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

Study Timeline

• Study Start: 2005-04
• Study First Submitted: 2005-09-14
• Study First Submitted QC: 2005-09-14
• Study First Posted: 2005-09-21
• Primary Completion: 2009-02
• Study Completion: 2009-02
• Results First Submitted: 2012-06-05
• Results First Submitted QC: 2012-06-05
• Results First Posted: 2012-07-09
• Status Verified: 2013-09
• Last Update Submitted: 2013-09-23
• Last Update Posted: 2013-10-28

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 24

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Flomax	Flomax	Patients on this arm will be given 0.4mg of Flomax to be taken for one month following their shock wave lithotripsy procedure.
Sugar pill	Sugar pill	Patients on this arm will be given a sugar pill to be taken for one month following their shock wave lithotripsy procedure.

Primary Outcome Measures

Name	Time	Method
Time to Passage of Stone Fragments	2 weeks and 3 months	Time to passage of stone fragments following shock wave lithotripsy as documented by patient diaries and follow-up radiographic imaging.

Secondary Outcome Measures

Name	Time	Method
Medical Evaluation	2 weeks and 3 months	Evaluation of pain assessments, lower urinary tract symptoms, side effects of study medication and need for hospitalizations and additional endoscopic procedures.

Trial Locations

Locations (1)

Emory University; 🇺🇸 Atlanta, Georgia, United States