We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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.)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00209131
First Posted: September 21, 2005
Last Update Posted: October 28, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Kenneth Ogan, MD, Emory University
  Purpose
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
Urolithiasis Drug: Flomax Drug: Sugar pill

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Kenneth Ogan, MD, Emory University:

Primary Outcome Measures:
  • 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:
  • 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.


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.
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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
  Contacts and Locations
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
  More Information

Responsible Party: Kenneth Ogan, MD, Associate Professor, Emory University
ClinicalTrials.gov Identifier: NCT00209131     History of Changes
Other Study ID Numbers: 0128-2005
First Submitted: September 14, 2005
First Posted: September 21, 2005
Results First Submitted: June 5, 2012
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