Differential Effect of Silodosin Versus Tamsulosin on Stone Clearance After Extra-corporeal Shock Wave Lithotripsy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE3

Study Classification

INTERVENTIONAL

Study Start Date

2012-03-31

Study Completion Date

2013-02-28

Brief Summary

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Tamsulosin is an alpha blocker usually prescribed for urinary complaints that has been shown to have some benefit in allowing kidney stones to pass through the ureter. Silodosin is a new alpha blocker that acts more rapidly than tamsulosin and has been shown to have specific receptors on the ureter. The investigators would like to see if there is some benefit to taking silodosin over tamsulosin after extra-corporeal shock wave lithotripsy (ESWL) to break kidney stones in terms of allowing the ureteral fragments to pass through the ureter. Our hypothesis is that silodosin will be at least as effective as tamsulosin in terms of allowing stones to pass, but may allow them to pass more quickly because of the rapid onset of action.

The side effect profile for both drugs is quite similar and tolerable. Patients may experience some common side effects associated with tamsulosin, including abnormal ejaculation, dizziness, rhinitis (runny nose, sneezing), and somnolence (sleepiness). Serious reactions include orthostatic hypotension, syncope (fainting), and priapism (prolonged undesired erection).

Patients may experience some common side effects with both silodosin and tamsulosin including ejaculatory dysfunction, dizziness, postural hypotension, diarrhea, and headache. Serious side effects are rare and include orthostatic hypotension, intra-operative floppy iris syndrome, syncope, and priapism.

Patients will experience the discomfort normally associated with kidney stones. All efforts will be made to alleviate these discomforts, including the use of the study medications. Patients will be able to take their routine prescribed pain medications, and will be asked to keep a record of their pain medication use.

The investigators will be randomly enrolling patients from all racial backgrounds and of both genders. They must have kidney stones ranging in size from 4mm to 1.0 cm and have no prior treatment for the study.

The primary endpoint of this study is the clearance rate of kidney stones. That is, in what period of time does the patient achieve clearance, is stone free and has all residual stones gone. The secondary endpoints of this study include analgesic use, residual stones remaining, need for re-treatment, need for intervention, steinstrasse clearance, and the need for hospitalization.

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Detailed Description

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A comparison between two commonly used alpha blockers to determine if there is superiority in the secondary usage of aiding in stone passage

Conditions

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Kidney Stones

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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Group A

Patients will receive ESWL and no medication

Group Type PLACEBO_COMPARATOR

Extra-corporeal shock wave lithotripsy

Intervention Type PROCEDURE

ESWL

Group B

Patients will receive Flomax after ESWL

Group Type ACTIVE_COMPARATOR

Extra-corporeal shock wave lithotripsy

Intervention Type PROCEDURE

ESWL

Tamsulosin

Intervention Type DRUG

Tamsulosin 0.4mg PO Qday

Group C

Patients will receive silodosin after ESWL

Group Type ACTIVE_COMPARATOR

silodosin

Intervention Type DRUG

8mg PO Qday

Extra-corporeal shock wave lithotripsy

Intervention Type PROCEDURE

ESWL

Interventions

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silodosin

8mg PO Qday

Intervention Type DRUG

Extra-corporeal shock wave lithotripsy

ESWL

Intervention Type PROCEDURE

Tamsulosin

Tamsulosin 0.4mg PO Qday

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Adults age 18 to 70
* Non-diabetics
* White blood cell count and serum creatinine level within normal range
* Urine analysis consistent with absence of infection
* Negative urine culture
* Absence of subjective or objective fever
* Ability to tolerate oral fluids and pain medication
* Unilateral ureteral calculus \< 10mm visible on CT scan within the ureter
* Ability to make informed medical decisions regarding consent
* Willingness to follow up in the urology office

Exclusion Criteria

Adults unable to consent

* Individuals who are not yet adults (infants, children, teenagers)
* Pregnant women
* Prisoners
* Prior treatment for this particular stone
* Medical therapy only for stone disease
* Chronic narcotic use
* Current alpha blocker therapy

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes