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

Phase 3

Withdrawn

• Conditions: Kidney Stones
• Interventions: Procedure: Extra-corporeal shock wave lithotripsy; Drug: silodosin; Drug: Tamsulosin

• Registration Number: NCT01560091
• Lead Sponsor: Albert Einstein Healthcare Network

Brief Summary

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.

Detailed Description

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

Study Timeline

• Study Start: 2012-03
• Study First Submitted: 2012-03-16
• Study First Submitted QC: 2012-03-21
• Study First Posted: 2012-03-22
• Primary Completion: 2013-02
• Study Completion: 2013-02
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-16
• Last Update Posted: 2017-02-17

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group A	Extra-corporeal shock wave lithotripsy	Patients will receive ESWL and no medication
Group B	Extra-corporeal shock wave lithotripsy	Patients will receive Flomax after ESWL
Group B	Tamsulosin	Patients will receive Flomax after ESWL
Group C	silodosin	Patients will receive silodosin after ESWL
Group C	Extra-corporeal shock wave lithotripsy	Patients will receive silodosin after ESWL

Primary Outcome Measures

Name	Time	Method
Clearance rate of kidney stones (days)	1 year	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. This outcome measure will be measured in days.

Secondary Outcome Measures

Name	Time	Method
Analgesic use	1 year	Analgesic use, number of pills of pain medication
need for re-treatment	1 year	need for re-treatment. Either the patient will need another ESWL, or hospitilization
need for intervention	1 year	need for intervention. Either ESWL again or hospitilization and further procedures such as laser lithotripsy, percutaneous nephrolithotomy, open surgery
steinstrasse clearance	1 year	steinstrasse clearance. Whether or not stone clearance is achieved or not
need for hospitalization	1 year	need for hospitalization. either yes or no
Residual stones remaining	1 year	Residual stones remaining, based on imaging

Trial Locations

Locations (1)

Albert Einstein Healthcare Network; 🇺🇸 Philadelphia, Pennsylvania, United States