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Efficacy of Flomax to Improve Stone Passage Following Shock Wave Lithotripsy

NCT ID: NCT00209131

Last Updated: 2013-10-28

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-04-30

Study Completion Date

2009-02-28

Brief Summary

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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

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

Conditions

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Urolithiasis

Keywords

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urolithiasis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Flomax

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

Group Type EXPERIMENTAL

Flomax

Intervention Type DRUG

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 pill

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

Group Type PLACEBO_COMPARATOR

Sugar pill

Intervention Type DRUG

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

Interventions

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Flomax

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.

Intervention Type DRUG

Sugar pill

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

Intervention Type DRUG

Other Intervention Names

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Tamsulosin Placebo pill

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Emory University

OTHER

Sponsor Role lead

Responsible Party

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Kenneth Ogan, MD

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Kenneth Ogan, MD

Role: PRINCIPAL_INVESTIGATOR

Emory University

Locations

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Emory University

Atlanta, Georgia, United States

Site Status

Countries

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United States

Other Identifiers

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0128-2005

Identifier Type: -

Identifier Source: org_study_id