Differential Effect of Silodosin Versus Tamsulosin on Stone Clearance After Extra-corporeal Shock Wave Lithotripsy
Primary Purpose
Kidney Stones
Status
Withdrawn
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
silodosin
Extra-corporeal shock wave lithotripsy
Tamsulosin
Sponsored by
About this trial
This is an interventional treatment trial for Kidney Stones focused on measuring clearance rate
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
Sites / Locations
- Albert Einstein Healthcare Network
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Placebo Comparator
Active Comparator
Active Comparator
Arm Label
Group A
Group B
Group C
Arm Description
Patients will receive ESWL and no medication
Patients will receive Flomax after ESWL
Patients will receive silodosin after ESWL
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Analgesic use
Analgesic use, number of pills of pain medication
Residual stones remaining
Residual stones remaining, based on imaging
need for re-treatment
need for re-treatment. Either the patient will need another ESWL, or hospitilization
need for intervention
need for intervention. Either ESWL again or hospitilization and further procedures such as laser lithotripsy, percutaneous nephrolithotomy, open surgery
steinstrasse clearance
steinstrasse clearance. Whether or not stone clearance is achieved or not
need for hospitalization
need for hospitalization. either yes or no
Full Information
NCT ID
NCT01560091
First Posted
March 16, 2012
Last Updated
February 16, 2017
Sponsor
Albert Einstein Healthcare Network
1. Study Identification
Unique Protocol Identification Number
NCT01560091
Brief Title
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
2. Study Status
Record Verification Date
February 2017
Overall Recruitment Status
Withdrawn
Why Stopped
accrual of subjects did not occur as anticipated
Study Start Date
March 2012 (undefined)
Primary Completion Date
February 2013 (Actual)
Study Completion Date
February 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Albert Einstein Healthcare Network
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Kidney Stones
Keywords
clearance rate
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group A
Arm Type
Placebo Comparator
Arm Description
Patients will receive ESWL and no medication
Arm Title
Group B
Arm Type
Active Comparator
Arm Description
Patients will receive Flomax after ESWL
Arm Title
Group C
Arm Type
Active Comparator
Arm Description
Patients will receive silodosin after ESWL
Intervention Type
Drug
Intervention Name(s)
silodosin
Intervention Description
8mg PO Qday
Intervention Type
Procedure
Intervention Name(s)
Extra-corporeal shock wave lithotripsy
Intervention Description
ESWL
Intervention Type
Drug
Intervention Name(s)
Tamsulosin
Intervention Description
Tamsulosin 0.4mg PO Qday
Primary Outcome Measure Information:
Title
Clearance rate of kidney stones (days)
Description
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.
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Analgesic use
Description
Analgesic use, number of pills of pain medication
Time Frame
1 year
Title
Residual stones remaining
Description
Residual stones remaining, based on imaging
Time Frame
1 year
Title
need for re-treatment
Description
need for re-treatment. Either the patient will need another ESWL, or hospitilization
Time Frame
1 year
Title
need for intervention
Description
need for intervention. Either ESWL again or hospitilization and further procedures such as laser lithotripsy, percutaneous nephrolithotomy, open surgery
Time Frame
1 year
Title
steinstrasse clearance
Description
steinstrasse clearance. Whether or not stone clearance is achieved or not
Time Frame
1 year
Title
need for hospitalization
Description
need for hospitalization. either yes or no
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Richard Harkaway, MD
Organizational Affiliation
Albert Einstein Healthcare Network
Official's Role
Principal Investigator
Facility Information:
Facility Name
Albert Einstein Healthcare Network
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19141
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Differential Effect of Silodosin Versus Tamsulosin on Stone Clearance After Extra-corporeal Shock Wave Lithotripsy
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