Kidney Stone
Conditions
Keywords
Kidney stone, Ureterolithiasis, Tamsulosin, Flowmax, Emergency Department
Brief summary
Tamsulosin (Flowmax)is approved by the FDA for the treatment for enlarged prostate. Several studies regarding the use of Tamsulosin for the treatment of lower kidney stones have been carried out in the non-Emergency Department setting. This study will compare Tamsulosin 0.4 mg with placebo in regards to rate and time of stone passing and will also look at amount of pain. The purpose of this study is to compare the usefulness of Tamsulosin versus placebo on time to stone passage and pain relief in Emergency Department patients with kidney stones.
Interventions
DRUGFlowmax
0.4 mg once a day until stone passage total = 9 tablets
DRUGplacebo
cornstarch
Sponsors
WellSpan Health
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 18 y.o. or older * diagnosed with a kidney stone less than or equal to 10 mm determined by CT scan * physician has made the decision that you will be discharged to home * must be able to take study medication for up to 10 days and strain your urine * must be able to keep a record of pain medication taken and complete a pain scale rating
Exclusion criteria
* patients currently taking: Tamsulosin (Flowmax), calcium channel blockers, beta blockers, alpha blockers, Sildenaphil (Viagara), Tadalaphil (Cilias), Warfarin (Coumadin, Jantoven), Cimetidine (Tagamet, Tagamet HB) * patients with a clinical and laboratory signs of: urinary tract infection, multiple kidney stones, diabetes, kidney failure, hypotension, pregnancy, fever * patient known to have hypersensitivity to Tamsulosin * patient history of cataract surgery * inability of patient to perform visual pain scale * allergy or intolerance to acetaminophen/oxycodone * patient is unable to understand informed consent * prisoners
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time of Stone Passage | 10 Days | Upon discharge, patient must be able to take the medication for 10 days and strain his/her urine. Patient must log the date and time of stone passage, if known. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Tamsulosin Flowmax: 0.4 mg once a day until stone passage total = 9 tablets | 28 |
| Placebo placebo: cornstarch | 25 |
| Total | 53 |
Baseline characteristics
| Characteristic | Tamsulosin | Placebo | Total |
|---|---|---|---|
| Age, Customized >=18 years | 28 participants | 25 participants | 53 participants |
| Sex: Female, Male Female | 11 Participants | 10 Participants | 21 Participants |
| Sex: Female, Male Male | 17 Participants | 15 Participants | 32 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 28 | 0 / 25 |
| serious Total, serious adverse events | 0 / 28 | 0 / 25 |
Outcome results
Primary
Time of Stone Passage
Upon discharge, patient must be able to take the medication for 10 days and strain his/her urine. Patient must log the date and time of stone passage, if known.
Time frame: 10 Days
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Tamsulosin | Time of Stone Passage | 68.8 hours |
| Placebo | Time of Stone Passage | 19.0 hours |