Efficacy of Flomax to Improve Stone Passage Following Shock Wave Lithotripsy
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|ClinicalTrials.gov Identifier: NCT00209131|
Recruitment Status : Terminated (Due to frequent turnover of research coordinators and thus poor study accrual.)
First Posted : September 21, 2005
Results First Posted : July 9, 2012
Last Update Posted : October 28, 2013
|Condition or disease||Intervention/treatment||Phase|
|Urolithiasis||Drug: Flomax Drug: Sugar pill||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||24 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Efficacy of Flomax to Improve Stone Passage Following Shock Wave Lithotripsy|
|Study Start Date :||April 2005|
|Actual Primary Completion Date :||February 2009|
|Actual Study Completion Date :||February 2009|
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
- 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.
- 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.
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
|United States, Georgia|
|Atlanta, Georgia, United States, 30322|
|Principal Investigator:||Kenneth Ogan, MD||Emory University|