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

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Abstract

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.

Description

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

Dates

Last Verified:	01/31/2017
First Submitted:	03/15/2012
Estimated Enrollment Submitted:	03/20/2012
First Posted:	03/21/2012
Last Update Submitted:	02/15/2017
Last Update Posted:	02/16/2017
Actual Study Start Date:	02/29/2012
Estimated Primary Completion Date:	01/31/2013
Estimated Study Completion Date:	01/31/2013

Condition or disease

Kidney Stones

Intervention/treatment

Drug: Group C

Procedure: Extra-corporeal shock wave lithotripsy

Drug: Group B

Phase

Phase 3

Arm Groups

Arm	Intervention/treatment
Placebo Comparator: Group A Patients will receive ESWL and no medication
Active Comparator: Group B Patients will receive Flomax after ESWL	Drug: Group B Tamsulosin 0.4mg PO Qday
Active Comparator: Group C Patients will receive silodosin after ESWL	Drug: Group C 8mg PO Qday

Eligibility Criteria

Ages Eligible for Study	18 Years To 18 Years
Sexes Eligible for Study	All
Accepts Healthy Volunteers	Yes
Criteria	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

Outcome

Primary Outcome Measures

1. Clearance rate of kidney stones (days) [1 year]

Secondary Outcome Measures

1. Analgesic use [1 year]

Analgesic use, number of pills of pain medication

2. Residual stones remaining [1 year]

Residual stones remaining, based on imaging

3. need for re-treatment [1 year]

need for re-treatment. Either the patient will need another ESWL, or hospitilization

4. need for intervention [1 year]

need for intervention. Either ESWL again or hospitilization and further procedures such as laser lithotripsy, percutaneous nephrolithotomy, open surgery

5. steinstrasse clearance [1 year]

steinstrasse clearance. Whether or not stone clearance is achieved or not

6. need for hospitalization [1 year]

need for hospitalization. either yes or no

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

Keywords

rhinitis

headache

dizziness

diarrhea

sleepiness

priapism

syncope

kidney calculi

hypotension

analgesic