Back to results

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

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

NCT ID

NCT00209131

First Posted

September 14, 2005

Last Updated

September 23, 2013

Sponsor

Emory University

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

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

Eligibility Criteria

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

Learn more about this trial

Efficacy of Flomax to Improve Stone Passage Following Shock Wave Lithotripsy

We'll reach out to this number within 24 hrs