Clinical trial NCT01560091: Differential Effect of Silodosin Versus Tamsulosin on Stone Clearance After Extra-corporeal Shock Wave Lithotripsy
Official title: Differential Effect of Silodosin Versus Tamsulosin on Stone Clearance After ESWL
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE3
Conditions: Kidney Stones
Keywords: clearance rate
Lead sponsor: Albert Einstein Healthcare Network
Sponsor class: OTHER
First posted: 2012-03-22
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Eligibility 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

Primary outcomes:
measure: Clearance rate of kidney stones (days)
timeFrame: 1 year
Secondary outcomes:
measure: Analgesic use
timeFrame: 1 year
measure: Residual stones remaining
timeFrame: 1 year
measure: need for re-treatment
timeFrame: 1 year
measure: need for intervention
timeFrame: 1 year
measure: steinstrasse clearance
timeFrame: 1 year
measure: need for hospitalization
timeFrame: 1 year
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Albert Einstein Healthcare Network
state: Pennsylvania
Study officials:
affiliation: Albert Einstein Healthcare Network
name: Richard Harkaway, MD
role: PRINCIPAL_INVESTIGATOR
References: