We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study has been withdrawn prior to enrollment.
(accrual of subjects did not occur as anticipated)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01560091
First Posted: March 22, 2012
Last Update Posted: February 17, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Richard Harkaway, Albert Einstein Healthcare Network
March 16, 2012
March 22, 2012
February 17, 2017
March 2012
February 2013   (Final data collection date for primary outcome measure)
Clearance rate of kidney stones (days) [ Time Frame: 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.
Same as current
Complete list of historical versions of study NCT01560091 on ClinicalTrials.gov Archive Site
  • Analgesic use [ Time Frame: 1 year ]
    Analgesic use, number of pills of pain medication
  • Residual stones remaining [ Time Frame: 1 year ]
    Residual stones remaining, based on imaging
  • need for re-treatment [ Time Frame: 1 year ]
    need for re-treatment. Either the patient will need another ESWL, or hospitilization
  • need for intervention [ Time Frame: 1 year ]
    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 ]
    steinstrasse clearance. Whether or not stone clearance is achieved or not
  • need for hospitalization [ Time Frame: 1 year ]
    need for hospitalization. either yes or no
Same as current
Not Provided
Not Provided
 
Differential Effect of Silodosin Versus Tamsulosin on Stone Clearance After Extra-corporeal Shock Wave Lithotripsy
Differential Effect of Silodosin Versus Tamsulosin on Stone Clearance After ESWL

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.

A comparison between two commonly used alpha blockers to determine if there is superiority in the secondary usage of aiding in stone passage
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Kidney Stones
  • Drug: silodosin
    8mg PO Qday
  • Procedure: Extra-corporeal shock wave lithotripsy
    ESWL
  • Drug: Tamsulosin
    Tamsulosin 0.4mg PO Qday
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
0
February 2013
February 2013   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 70 Years   (Adult, Senior)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01560091
HN 4378
Yes
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Plan to Share IPD: Undecided
Richard Harkaway, Albert Einstein Healthcare Network
Albert Einstein Healthcare Network
Not Provided
Principal Investigator: Richard Harkaway, MD Albert Einstein Healthcare Network
Albert Einstein Healthcare Network
February 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP