Efficacy of Flomax to Improve Stone Passage Following Shock Wave Lithotripsy

Emory University

Status: Terminated

Conditions: Urolithiasis

Treatments: Drug: Sugar pill; Drug: Flomax

Study type: Interventional

Funder types: Other

Identifiers

NCT00209131

0128-2005

Details and patient eligibility

About

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.

Full description

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

Enrollment: 24 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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24 participants in 2 patient groups, including a placebo group

Flomax

Experimental group

Description:

Patients on this arm will be given 0.4mg of Flomax to be taken for one month following their shock wave lithotripsy procedure.

Treatment:

Drug: Flomax

Sugar pill

Placebo Comparator group

Description:

Patients on this arm will be given a sugar pill to be taken for one month following their shock wave lithotripsy procedure.

Treatment:

Drug: Sugar pill