Kidney Stones Clinical Trial
Official title:
Differential Effect of Silodosin Versus Tamsulosin on Stone Clearance After ESWL
Verified date | February 2017 |
Source | Albert Einstein Healthcare Network |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | February 2013 |
Est. primary completion date | February 2013 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 70 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
United States | Albert Einstein Healthcare Network | Philadelphia | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
Albert Einstein Healthcare Network |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Clearance rate of kidney stones (days) | 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. | 1 year | |
Secondary | Analgesic use | Analgesic use, number of pills of pain medication | 1 year | |
Secondary | Residual stones remaining | Residual stones remaining, based on imaging | 1 year | |
Secondary | need for re-treatment | need for re-treatment. Either the patient will need another ESWL, or hospitilization | 1 year | |
Secondary | need for intervention | need for intervention. Either ESWL again or hospitilization and further procedures such as laser lithotripsy, percutaneous nephrolithotomy, open surgery | 1 year | |
Secondary | steinstrasse clearance | steinstrasse clearance. Whether or not stone clearance is achieved or not | 1 year | |
Secondary | need for hospitalization | need for hospitalization. either yes or no | 1 year |
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