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Efficacy of Flomax to Improve Stone Passage Following Shock Wave Lithotripsy

Primary Purpose

Urolithiasis

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Flomax
Sugar pill
Sponsored by
Emory University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Urolithiasis focused on measuring urolithiasis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Emory University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Flomax

Sugar pill

Arm Description

Patients on this arm will be given 0.4mg of Flomax to be taken for one month following their shock wave lithotripsy procedure.

Patients on this arm will be given a sugar pill to be taken for one month following their shock wave lithotripsy procedure.

Outcomes

Primary Outcome Measures

Time to Passage of Stone Fragments
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
Evaluation of pain assessments, lower urinary tract symptoms, side effects of study medication and need for hospitalizations and additional endoscopic procedures.

Full Information

First Posted
September 14, 2005
Last Updated
September 23, 2013
Sponsor
Emory University
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1. Study Identification

Unique Protocol Identification Number
NCT00209131
Brief Title
Efficacy of Flomax to Improve Stone Passage Following Shock Wave Lithotripsy
Official Title
Efficacy of Flomax to Improve Stone Passage Following Shock Wave Lithotripsy
Study Type
Interventional

2. Study Status

Record Verification Date
September 2013
Overall Recruitment Status
Terminated
Why Stopped
Due to frequent turnover of research coordinators and thus poor study accrual.
Study Start Date
April 2005 (undefined)
Primary Completion Date
February 2009 (Actual)
Study Completion Date
February 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Emory University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urolithiasis
Keywords
urolithiasis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Flomax
Arm Type
Experimental
Arm Description
Patients on this arm will be given 0.4mg of Flomax to be taken for one month following their shock wave lithotripsy procedure.
Arm Title
Sugar pill
Arm Type
Placebo Comparator
Arm Description
Patients on this arm will be given a sugar pill to be taken for one month following their shock wave lithotripsy procedure.
Intervention Type
Drug
Intervention Name(s)
Flomax
Other Intervention Name(s)
Tamsulosin
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Sugar pill
Other Intervention Name(s)
Placebo pill
Intervention Description
Comparable sugar pills will be given to the placebo group to take daily for one month following shock wave lithotripsy to aid stone passage.
Primary Outcome Measure Information:
Title
Time to Passage of Stone Fragments
Description
Time to passage of stone fragments following shock wave lithotripsy as documented by patient diaries and follow-up radiographic imaging.
Time Frame
2 weeks and 3 months
Secondary Outcome Measure Information:
Title
Medical Evaluation
Description
Evaluation of pain assessments, lower urinary tract symptoms, side effects of study medication and need for hospitalizations and additional endoscopic procedures.
Time Frame
2 weeks and 3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kenneth Ogan, MD
Organizational Affiliation
Emory University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Emory University
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States

12. IPD Sharing Statement

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Efficacy of Flomax to Improve Stone Passage Following Shock Wave Lithotripsy

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