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Efficacy of Flomax to Improve Stone Passage Following Shock Wave Lithotripsy

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ClinicalTrials.gov Identifier: NCT00209131
Recruitment Status : Terminated (Due to frequent turnover of research coordinators and thus poor study accrual.)
First Posted : September 21, 2005
Results First Posted : July 9, 2012
Last Update Posted : October 28, 2013
Sponsor:
Information provided by (Responsible Party):
Kenneth Ogan, MD, Emory University

Brief Summary:
The majority of kidney stones are treated with shock wave lithotripsy (SWL). We are examining if the medication Flomax will result in improved stone passage rates following SWL.

Condition or disease Intervention/treatment Phase
Urolithiasis Drug: Flomax Drug: Sugar pill Not Applicable

Detailed Description:
Placebo blinded study examining the effects of Flomax on stone passage rates following SWL.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Efficacy of Flomax to Improve Stone Passage Following Shock Wave Lithotripsy
Study Start Date : April 2005
Actual Primary Completion Date : February 2009
Actual Study Completion Date : February 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Shock
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Flomax
Patients on this arm will be given 0.4mg of Flomax to be taken for one month following their shock wave lithotripsy procedure.
Drug: Flomax
0.4mg Flomax pills will be given to patients to take once daily for one month following shock wave lithotripsy to aid the stone passage.
Other Name: Tamsulosin
Placebo Comparator: Sugar pill
Patients on this arm will be given a sugar pill to be taken for one month following their shock wave lithotripsy procedure.
Drug: Sugar pill
Comparable sugar pills will be given to the placebo group to take daily for one month following shock wave lithotripsy to aid stone passage.
Other Name: Placebo pill



Primary Outcome Measures :
  1. Time to Passage of Stone Fragments [ Time Frame: 2 weeks and 3 months ]
    Time to passage of stone fragments following shock wave lithotripsy as documented by patient diaries and follow-up radiographic imaging.


Secondary Outcome Measures :
  1. Medical Evaluation [ Time Frame: 2 weeks and 3 months ]
    Evaluation of pain assessments, lower urinary tract symptoms, side effects of study medication and need for hospitalizations and additional endoscopic procedures.



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients 18 years old and above with urolithiasis scheduled for shock wave lithotripsy.

Exclusion Criteria:

  • Contraindications to Flomax
  • Patients with renal impairment (serum creatinine above 2.0)
  • Patients with hepatic impairment (liver enzymes 2.5 times the upper limit of normal)
  • Use of other oral alpha blockers

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): NCT00209131


Locations
United States, Georgia
Emory University
Atlanta, Georgia, United States, 30322
Sponsors and Collaborators
Emory University
Investigators
Principal Investigator: Kenneth Ogan, MD Emory University

Responsible Party: Kenneth Ogan, MD, Associate Professor, Emory University
ClinicalTrials.gov Identifier: NCT00209131     History of Changes
Other Study ID Numbers: 0128-2005
First Posted: September 21, 2005    Key Record Dates
Results First Posted: July 9, 2012
Last Update Posted: October 28, 2013
Last Verified: September 2013

Keywords provided by Kenneth Ogan, MD, Emory University:
urolithiasis

Additional relevant MeSH terms:
Urolithiasis
Urologic Diseases
Tamsulosin
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