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.

Study Overview

• Status: Withdrawn
• Conditions: Kidney Stones
• Intervention / Treatment: Procedure: Extra-corporeal shock wave lithotripsy; Drug: Tamsulosin; Drug: silodosin

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

• Study Type: Interventional
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19141
      • Albert Einstein Healthcare Network

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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	Procedure: Extra-corporeal shock wave lithotripsy; ESWL; Drug: silodosin; 8mg PO Qday

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Analgesic use	Analgesic use, number of pills of pain medication	1 year
Residual stones remaining	Residual stones remaining, based on imaging	1 year
need for re-treatment	need for re-treatment. Either the patient will need another ESWL, or hospitilization	1 year
need for intervention	need for intervention. Either ESWL again or hospitilization and further procedures such as laser lithotripsy, percutaneous nephrolithotomy, open surgery	1 year
steinstrasse clearance	steinstrasse clearance. Whether or not stone clearance is achieved or not	1 year
need for hospitalization	need for hospitalization. either yes or no	1 year

Collaborators and Investigators

• Sponsor: Albert Einstein Healthcare Network
• Investigators: Principal Investigator: Richard Harkaway, MD, Albert Einstein Healthcare Network

Study record dates

Study Major Dates

• Study Start: March 1, 2012
• Primary Completion (Actual): February 1, 2013
• Study Completion (Actual): February 1, 2013

Study Registration Dates

• First Submitted: March 16, 2012
• First Submitted That Met QC Criteria: March 21, 2012
• First Posted (Estimate): March 22, 2012

Study Record Updates

• Last Update Posted (Actual): February 17, 2017
• Last Update Submitted That Met QC Criteria: February 16, 2017
• Last Verified: February 1, 2017

More Information

Terms related to this study

• Keywords: clearance rate
• Additional Relevant MeSH Terms: Kidney Diseases; Urologic Diseases; Pathological Conditions, Anatomical; Urolithiasis; Urinary Calculi; Calculi; Nephrolithiasis; Kidney Calculi; Physiological Effects of Drugs; Adrenergic Antagonists; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Urological Agents; Adrenergic alpha-1 Receptor Antagonists; Adrenergic alpha-Antagonists; Tamsulosin; Silodosin
• Other Study ID Numbers: HN 4378

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No