Urolithiasis
Conditions
Keywords
urolithiasis
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.
Interventions
DRUGFlomax
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.
DRUGSugar 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.
Sponsors
Emory University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to Passage of Stone Fragments | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Medical Evaluation | 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. |
Countries
United States
Participant flow
Recruitment details
Patient recruitment took place in a medical clinic affiliated with a teaching hospital from May 2005 through February 2009.
Participants by arm
| Arm | Count |
|---|---|
| Flomax Patients on this arm will be given 0.4mg of Flomax to be taken for one month following their shock wave lithotripsy procedure. | 15 |
| Sugar Pill Patients on this arm will be given a sugar pill to be taken for one month following their shock wave lithotripsy procedure. | 11 |
| Total | 26 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lack of personnel due to turnovers. | 15 | 11 |
Baseline characteristics
| Characteristic | Sugar Pill | Flomax | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 11 Participants | 15 Participants | 26 Participants |
| Age Continuous | 53 years STANDARD_DEVIATION 5 | 55 years STANDARD_DEVIATION 5 | 54 years STANDARD_DEVIATION 5 |
| Region of Enrollment United States | 11 participants | 15 participants | 26 participants |
| Sex: Female, Male Female | 4 Participants | 7 Participants | 11 Participants |
| Sex: Female, Male Male | 7 Participants | 8 Participants | 15 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
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.
Time frame: 2 weeks and 3 months
Population: No analysis was conducted.
Comparison: No analysis was conducted.p-value: <0.05Other
Secondary
Medical Evaluation
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