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Efficacy of Flomax to Improve Stone Passage Following Shock Wave Lithotripsy

This study has been terminated.
(Due to frequent turnover of research coordinators and thus poor study accrual.)
Information provided by (Responsible Party):
Kenneth Ogan, MD, Emory University Identifier:
First received: September 14, 2005
Last updated: September 23, 2013
Last verified: September 2013
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 Intervention
Drug: Flomax
Drug: Sugar pill

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Efficacy of Flomax to Improve Stone Passage Following Shock Wave Lithotripsy

Resource links provided by NLM:

Further study details as provided by Emory University:

Primary Outcome Measures:
  • Time to Passage of Stone Fragments [ Time Frame: 2 weeks and 3 months ] [ Designated as safety issue: No ]
    Time to passage of stone fragments following shock wave lithotripsy as documented by patient diaries and follow-up radiographic imaging.

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

Enrollment: 24
Study Start Date: April 2005
Study Completion Date: February 2009
Primary Completion Date: February 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT00209131

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

Responsible Party: Kenneth Ogan, MD, Associate Professor, Emory University Identifier: NCT00209131     History of Changes
Other Study ID Numbers: 0128-2005 
Study First Received: September 14, 2005
Results First Received: June 5, 2012
Last Updated: September 23, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Emory University:

Additional relevant MeSH terms:
Urologic Diseases
Polystyrene sulfonic acid
Chelating Agents
Sequestering Agents
Molecular Mechanisms of Pharmacological Action
Adrenergic alpha-1 Receptor Antagonists
Adrenergic alpha-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Urological Agents processed this record on October 20, 2016