Trial Outcomes & Findings for Efficacy of Flomax to Improve Stone Passage Following Shock Wave Lithotripsy (NCT NCT00209131)

Results Overview

Time to passage of stone fragments following shock wave lithotripsy as documented by patient diaries and follow-up radiographic imaging.

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

24 participants

Primary outcome timeframe

2 weeks and 3 months

Results posted on

2013-10-28

Participant Flow

Patient recruitment took place in a medical clinic affiliated with a teaching hospital from May 2005 through February 2009.

Participant milestones

Participant milestones
Measure	Flomax Patients on this arm will be given 0.4mg of Flomax to be taken for one month following their shock wave lithotripsy procedure.	Sugar Pill Patients on this arm will be given a sugar pill to be taken for one month following their shock wave lithotripsy procedure.
Overall Study STARTED	15	11
Overall Study COMPLETED	0	0
Overall Study NOT COMPLETED	15	11

Reasons for withdrawal

Reasons for withdrawal
Measure	Flomax Patients on this arm will be given 0.4mg of Flomax to be taken for one month following their shock wave lithotripsy procedure.	Sugar Pill Patients on this arm will be given a sugar pill to be taken for one month following their shock wave lithotripsy procedure.
Overall Study Lack of personnel due to turnovers.	15	11

Baseline Characteristics

Efficacy of Flomax to Improve Stone Passage Following Shock Wave Lithotripsy

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Flomax n=15 Participants Patients on this arm will be given 0.4mg of Flomax to be taken for one month following their shock wave lithotripsy procedure.	Sugar Pill n=11 Participants Patients on this arm will be given a sugar pill to be taken for one month following their shock wave lithotripsy procedure.	Total n=26 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	15 Participants n=5 Participants	11 Participants n=7 Participants	26 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age Continuous	55 years STANDARD_DEVIATION 5 • n=5 Participants	53 years STANDARD_DEVIATION 5 • n=7 Participants	54 years STANDARD_DEVIATION 5 • n=5 Participants
Sex: Female, Male Female	7 Participants n=5 Participants	4 Participants n=7 Participants	11 Participants n=5 Participants
Sex: Female, Male Male	8 Participants n=5 Participants	7 Participants n=7 Participants	15 Participants n=5 Participants
Region of Enrollment United States	15 participants n=5 Participants	11 participants n=7 Participants	26 participants n=5 Participants

PRIMARY outcome

Timeframe: 2 weeks and 3 months

Population: No analysis was conducted.

Time to passage of stone fragments following shock wave lithotripsy as documented by patient diaries and follow-up radiographic imaging.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome data not reported

Adverse Events

Flomax

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Sugar Pill

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Kenneth Ogan

Emory University

Phone: 404-778-4898

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place