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

This study is not yet open for participant recruitment.

Verified March 2012 by Albert Einstein Healthcare Network

Sponsor:

Information provided by (Responsible Party):

Ali Husain, Albert Einstein Healthcare Network

ClinicalTrials.gov Identifier:

NCT01560091

First received: March 16, 2012

Last updated: March 21, 2012

Last verified: March 2012

History of Changes

Tracking Information
First Received Date ^ICMJE	March 16, 2012
Last Updated Date	March 21, 2012
Start Date ^ICMJE	March 2012
Estimated Primary Completion Date	March 2013 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: March 21, 2012)	Clearance rate of kidney stones (days) [ Time Frame: 1 year ] [ Designated as safety issue: Yes ] 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.
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01560091 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: March 21, 2012)	Analgesic use [ Time Frame: 1 year ] [ Designated as safety issue: Yes ] Analgesic use, number of pills of pain medication Residual stones remaining [ Time Frame: 1 year ] [ Designated as safety issue: No ] Residual stones remaining, based on imaging need for re-treatment [ Time Frame: 1 year ] [ Designated as safety issue: No ] need for re-treatment. Either the patient will need another ESWL, or hospitilization need for intervention [ Time Frame: 1 year ] [ Designated as safety issue: No ] need for intervention. Either ESWL again or hospitilization and further procedures such as laser lithotripsy, percutaneous nephrolithotomy, open surgery steinstrasse clearance [ Time Frame: 1 year ] [ Designated as safety issue: No ] steinstrasse clearance. Whether or not stone clearance is achieved or not need for hospitalization [ Time Frame: 1 year ] [ Designated as safety issue: No ] need for hospitalization. either yes or no
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Differential Effect of Silodosin Versus Tamsulosin on Stone Clearance After Extra-corporeal Shock Wave Lithotripsy
Official Title ^ICMJE	Differential Effect of Silodosin Versus Tamsulosin on Stone Clearance After ESWL
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	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Not Provided
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Condition ^ICMJE	Kidney Stones
Intervention ^ICMJE	Drug: silodosin 8mg PO Qday Procedure: Extra-corporeal shock wave lithotripsy ESWL Drug: Tamsulosin Tamsulosin 0.4mg PO Qday
Study Arm (s)	Placebo Comparator: Group A Patients will receive ESWL and no medication Intervention: Procedure: Extra-corporeal shock wave lithotripsy Active Comparator: Group B Patients will receive Flomax after ESWL Interventions: Procedure: Extra-corporeal shock wave lithotripsy Drug: Tamsulosin Active Comparator: Group C Patients will receive silodosin after ESWL Interventions: Drug: silodosin Procedure: Extra-corporeal shock wave lithotripsy
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Not yet recruiting
Estimated Enrollment ^ICMJE	90
Estimated Completion Date	March 2013
Estimated Primary Completion Date	March 2013 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	18 Years to 70 Years
Accepts Healthy Volunteers	Yes
Contacts ^ICMJE	Not Provided
Location Countries ^ICMJE	United States

Administrative Information
NCT Number ^ICMJE	NCT01560091
Other Study ID Numbers ^ICMJE	HN 4378
Has Data Monitoring Committee	Yes
Responsible Party	Ali Husain, Albert Einstein Healthcare Network
Study Sponsor ^ICMJE	Albert Einstein Healthcare Network
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Albert Einstein Healthcare Network
Verification Date	March 2012
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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