Efficacy of Flomax to Improve Stone Passage Following Shock Wave Lithotripsy

Urolithiasis Clinical Trial

Official title:

Efficacy of Flomax to Improve Stone Passage Following Shock Wave Lithotripsy

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00209131
• Other study ID #: 0128-2005
• Status: Terminated
• Phase: N/A
• First received: September 14, 2005
• Last updated: September 23, 2013
• Start date: April 2005
• Est. completion date: February 2009

Study information

• Verified date: September 2013
• Source: Emory University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 24
• Est. completion date: February 2009
• Est. primary completion date: February 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Urolithiasis

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Emory University	Atlanta	Georgia

Sponsors (1)

Lead Sponsor	Collaborator
Emory University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	2 weeks and 3 months	No
Secondary	Medical Evaluation	Evaluation of pain assessments, lower urinary tract symptoms, side effects of study medication and need for hospitalizations and additional endoscopic procedures.	2 weeks and 3 months	Yes