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

NCT01560091 | Withdrawn Phase 3 DMC FDA Drug

• 1 other identifier: HN 4378
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Kidney Stones

Keywords

clearance rate

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Analgesic use

  1 year

• Residual stones remaining

  1 year

• need for re-treatment

  1 year

• need for intervention

  1 year

• steinstrasse clearance

  1 year

Study Arms (3)

Group A

PLACEBO COMPARATOR

Patients will receive ESWL and no medication

Procedure: Extra-corporeal shock wave lithotripsy

Group B

ACTIVE COMPARATOR

Patients will receive Flomax after ESWL

Procedure: Extra-corporeal shock wave lithotripsy; Drug: Tamsulosin

Group C

ACTIVE COMPARATOR

Patients will receive silodosin after ESWL

Drug: silodosin; Procedure: Extra-corporeal shock wave lithotripsy

Interventions

silodosin DRUG

8mg PO Qday

Group C

Extra-corporeal shock wave lithotripsy PROCEDURE

ESWL

Group A; Group B; Group C

Tamsulosin DRUG

Tamsulosin 0.4mg PO Qday

Group B

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Albert Einstein Healthcare Network: lead

Study Sites (1)

Albert Einstein Healthcare Network

Philadelphia, Pennsylvania, 19141, United States

Location

MeSH Terms

Conditions

Kidney Calculi

Interventions

silodosin; Tamsulosin

Condition Hierarchy (Ancestors)

Nephrolithiasis; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urolithiasis; Urinary Calculi; Male Urogenital Diseases; Calculi; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Benzenesulfonamides; Sulfonamides; Amides; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Sulfones; Sulfur Compounds

Study Officials

• Richard Harkaway, MD

  Albert Einstein Healthcare Network

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PRINCIPAL INVESTIGATOR

Study Record Dates

• First Submitted: March 16, 2012
• First Posted: March 22, 2012
• Study Start: March 1, 2012
• Primary Completion: February 1, 2013
• Study Completion: February 1, 2013
• Last Updated: February 17, 2017

Record last verified: 2017-02

Locations

US (1)