Effect of Tamsulosin on Stone Expulsion and Pain Resolution in ED Patients With Ureterolithiasis

NCT00762424 | Completed Results

• 1 other identifier: 0607030
• Study Type: interventional
• Target: 53
• Locations: 1 country
• Sites: 1

Brief Summary

Tamsulosin (Flowmax)is approved by the FDA for the treatment for enlarged prostate. Several studies regarding the use of Tamsulosin for the treatment of lower kidney stones have been carried out in the non-Emergency Department setting. This study will compare Tamsulosin 0.4 mg with placebo in regards to rate and time of stone passing and will also look at amount of pain. The purpose of this study is to compare the usefulness of Tamsulosin versus placebo on time to stone passage and pain relief in Emergency Department patients with kidney stones.

Conditions

Kidney Stone

Keywords

Kidney stone; Ureterolithiasis; Tamsulosin; Flowmax; Emergency Department

Outcome Measures

Primary Outcomes (1)

• Time of Stone Passage

  Upon discharge, patient must be able to take the medication for 10 days and strain his/her urine. Patient must log the date and time of stone passage, if known.

  10 Days

Study Arms (2)

Tamsulosin

ACTIVE COMPARATOR

Drug: Flowmax

Placebo

PLACEBO COMPARATOR

Drug: placebo

Interventions

Flowmax DRUG

0.4 mg once a day until stone passage total = 9 tablets

Tamsulosin

placebo DRUG

cornstarch

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• y.o. or older
• diagnosed with a kidney stone less than or equal to 10 mm determined by CT scan
• physician has made the decision that you will be discharged to home
• must be able to take study medication for up to 10 days and strain your urine
• must be able to keep a record of pain medication taken and complete a pain scale rating

You may not qualify if:

• patients currently taking: Tamsulosin (Flowmax), calcium channel blockers, beta blockers, alpha blockers, Sildenaphil (Viagara), Tadalaphil (Cilias), Warfarin (Coumadin, Jantoven), Cimetidine (Tagamet, Tagamet HB)
• patients with a clinical and laboratory signs of: urinary tract infection, multiple kidney stones, diabetes, kidney failure, hypotension, pregnancy, fever
• patient known to have hypersensitivity to Tamsulosin
• patient history of cataract surgery
• inability of patient to perform visual pain scale
• allergy or intolerance to acetaminophen/oxycodone
• patient is unable to understand informed consent
• prisoners

Sponsors & Collaborators

• WellSpan Health: lead

Study Sites (1)

York Hospital Emergency Department

York, Pennsylvania, 17405, United States

Location

MeSH Terms

Conditions

Kidney Calculi; Ureterolithiasis; Emergencies

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; Ureteral Diseases; Disease Attributes; Pathologic Processes

Results Point of Contact

• Title: Barbara Stahlman MS, Clinical Research Associate
• Organization: WellSpan Health

bstahlman@wellspan.org

717-851-2450

Study Officials

• Marc Pollack, MD, PhD

  WellSpan Health

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 26, 2008
• First Posted: September 30, 2008
• Study Start: June 1, 2007
• Primary Completion: January 1, 2011
• Study Completion: January 1, 2011
• Last Updated: December 17, 2014
• Results First Posted: December 17, 2014

Record last verified: 2014-12

Locations

US (1)