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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This study has been withdrawn prior to enrollment.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
  Purpose

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.


Condition Intervention Phase
Kidney Stones Drug: silodosin Procedure: Extra-corporeal shock wave lithotripsy Drug: Tamsulosin Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Differential Effect of Silodosin Versus Tamsulosin on Stone Clearance After ESWL

Resource links provided by NLM:


Further study details as provided by Richard Harkaway, Albert Einstein Healthcare Network:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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


Enrollment: 0
Study Start Date: March 2012
Study Completion Date: February 2013
Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Group A
Patients will receive ESWL and no medication
Procedure: Extra-corporeal shock wave lithotripsy
ESWL
Active Comparator: Group B
Patients will receive Flomax after ESWL
Procedure: Extra-corporeal shock wave lithotripsy
ESWL
Drug: Tamsulosin
Tamsulosin 0.4mg PO Qday
Active Comparator: Group C
Patients will receive silodosin after ESWL
Drug: silodosin
8mg PO Qday
Procedure: Extra-corporeal shock wave lithotripsy
ESWL

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01560091


Locations
United States, Pennsylvania
Albert Einstein Healthcare Network
Philadelphia, Pennsylvania, United States, 19141
Sponsors and Collaborators
Albert Einstein Healthcare Network
Investigators
Principal Investigator: Richard Harkaway, MD Albert Einstein Healthcare Network
  More Information

Responsible Party: Richard Harkaway, PRINCIPAL INVESTIGATOR, Albert Einstein Healthcare Network
ClinicalTrials.gov Identifier: NCT01560091     History of Changes
Other Study ID Numbers: HN 4378
First Submitted: March 16, 2012
First Posted: March 22, 2012
Last Update Posted: February 17, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Richard Harkaway, Albert Einstein Healthcare Network:
clearance rate

Additional relevant MeSH terms:
Kidney Calculi
Nephrolithiasis
Kidney Diseases
Urologic Diseases
Urolithiasis
Urinary Calculi
Calculi
Pathological Conditions, Anatomical
Tamsulosin
Silodosin
Adrenergic alpha-1 Receptor Antagonists
Adrenergic alpha-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Urological Agents