Efficacy of Flomax to Improve Stone Passage Following Shock Wave Lithotripsy
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.
|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|
- 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.
- 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.
|Study Start Date:||April 2005|
|Study Completion Date:||February 2009|
|Primary Completion Date:||February 2009 (Final data collection date for primary outcome measure)|
Patients on this arm will be given 0.4mg of Flomax to be taken for one month following their shock wave lithotripsy procedure.
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
Placebo blinded study examining the effects of Flomax on stone passage rates following SWL.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00209131
|United States, Georgia|
|Atlanta, Georgia, United States, 30322|
|Principal Investigator:||Kenneth Ogan, MD||Emory University|