Kidney Stones, Ureteral Stones
Conditions
Keywords
Kidney Stones, Ureteral Stones, Flomax, Emergency Medicine, Urology
Brief summary
To determine if emergency department patients with acute ureteral colic pain due to a ureteral stone who are treated with tamsulosin, versus placebo, will experience a shorter time to passage of their stone or resolution of their pain. A secondary study objective will be to determine if there is a relationship between response to tamsulosin and stone size or position in the ureter.
Detailed description
This is a prospective randomized placebo controlled study of tamsulosin alone, vs placebo, to determine its effect on the rates of stone passage and resolution of pain in patients with acute renal colic pain that present to the emergency department. The study will be conducted in the Emergency Department (ED)and Emergency Department Observation Unit (EDOU) of William Beaumont Hospital, a high volume, university affiliated 952 bed suburban teaching hospital. Patients will be given a seven-day supply of tamsulosin (0.4mg daily) or placebo. They will also be given a prescription for Vicodin (30 pills) and Ibuprofen (600mg, 30 pills). They will be called on days 1, 2, 3, 7, and 10 following the index visit regarding passage of stone or 48 hours without pain. Patients will be asked to call in if they pass their stone or are without pain for 48 hours. Related return visits to Royal Oak or Troy Beaumont within 30 days of their index visit will be followed by chart review. The study will be limited to patients presenting to the emergency department with acutely symptomatic renal colic pain. Confirmation of a symptomatic stone will be made by imaging (helical CT scan or intravenous pyelogram). Study exclusion criteria: * Stone not documented on imaging * Stones \>10mm * Pregnancy * Age \<18 years * Evidence of infection with an obstructing stone * Obstructing stone in a solitary kidney * Currently taking tamsulosin, vardenafil, nifedipine, or steroids * Contraindications or allergy to tamsulosin * Ureteral surgery * Patients that are unable to understand consent * Patients that are unable to comply with follow-up
Interventions
DRUGTamsulosin
Study Drug
DRUGPlacebo
Placebo
Sponsors
Corewell Health East
Robert Swor
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Emergency Department patients with acutely symptomatic renal colic pain * Confirmation of a symptomatic stone will be made by imaging (helical CT scan or intravenous pyelogram).
Exclusion criteria
* Stones not documented on imaging * Stones \>10mm * Pregnancy * Age \<18 years * Evidence of infection with an obstructing stone * Obstructing stone in a solitary kidney * Currently taking tamsulosin, vardenafil, nifedipine, or steroids * Contraindications or allergy to tamsulosin * Ureteral surgery * Patients that are unable to understand consent * Patients that are unable to comply with follow-up
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Stone Passage | 1-7 days | Participants were asked during the follow-up phone call to indicate if their stone had passed within seven days. Phone calls were conducted at days 1, 2, 3, 7, 10 and 30 days after the emergency department discharge. Data is reported based on the information obtained up to the 7th day. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Amount (Mean Number of Tablets Taken) of Pain Medication Taken by Subjects up to Seven (7) Days Post Emergency Department Discharge | 1-7 days | — |
| High Pain Score by Treatment Group | 7 Days | Severity of Patient Pain at 7 days Post Emergency Department Visit. Patients were asked to describe their pain severity at each followup phone call, using a numerical scale, ranging from 0 (no pain) to 10 (worst possible pain). We report this measure at 7 days. |
Countries
United States
Participant flow
Recruitment details
127 subjects were enrolled in the study and 100 completed the study. Of the 27 that were excluded from analysis, 15 were excluded due to 'lost to follow-up', and another 12 had their stone removed surgically (physician decision) by the 7th day.
Participants by arm
| Arm | Count |
|---|---|
| Placebo Placebo Group | 62 |
| Tamsulosin Intervention - Tamsulosin
Tamsulosin: Study Drug | 65 |
| Total | 127 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 9 | 6 |
| Overall Study | Physician Decision | 6 | 6 |
Baseline characteristics
| Characteristic | Placebo | Tamsulosin | 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 | 62 Participants | 65 Participants | 127 Participants |
| Region of Enrollment United States | 62 participants | 65 participants | 127 participants |
| Sex: Female, Male Female | 23 Participants | 23 Participants | 46 Participants |
| Sex: Female, Male Male | 39 Participants | 42 Participants | 81 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 5 / 47 | 4 / 53 |
| serious Total, serious adverse events | 0 / 47 | 0 / 53 |
Outcome results
Primary
Stone Passage
Participants were asked during the follow-up phone call to indicate if their stone had passed within seven days. Phone calls were conducted at days 1, 2, 3, 7, 10 and 30 days after the emergency department discharge. Data is reported based on the information obtained up to the 7th day.
Time frame: 1-7 days
Population: In the placebo group, of the 47 subjects 18 (46.2%) passed their stone by Day 7. In the Tamsulosin group, of the 53 subjects 21 (53.9%) passed their stone by Day 7.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Stone Passage | 18 participants |
| Tamsulosin | Stone Passage | 21 participants |
Secondary
Amount (Mean Number of Tablets Taken) of Pain Medication Taken by Subjects up to Seven (7) Days Post Emergency Department Discharge
Time frame: 1-7 days
Population: The data table is limited to the information collected at Day 7. Of the 53 subjects in the placebo group only 29 provided information regarding pain medication at the Day 7 interview. For the Tamsulosin group, only 15 out of 47 provided the pain medication information at the Day 7 interview. At Day 7 each group had only 3 non-zero responses.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Placebo | Amount (Mean Number of Tablets Taken) of Pain Medication Taken by Subjects up to Seven (7) Days Post Emergency Department Discharge | 0.4 Pain tablets |
| Tamsulosin | Amount (Mean Number of Tablets Taken) of Pain Medication Taken by Subjects up to Seven (7) Days Post Emergency Department Discharge | 0.6 Pain tablets |
Secondary
High Pain Score by Treatment Group
Severity of Patient Pain at 7 days Post Emergency Department Visit. Patients were asked to describe their pain severity at each followup phone call, using a numerical scale, ranging from 0 (no pain) to 10 (worst possible pain). We report this measure at 7 days.
Time frame: 7 Days
Population: The data table is limited to the information collected at Day 7. Of the 53 subjects in the placebo group only 29 provided information at the Day 7 interview. For the Tamsulosin group, only 15 out of 47 provided information at the Day 7 interview.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Placebo | High Pain Score by Treatment Group | 1.69 units on a scale |
| Tamsulosin | High Pain Score by Treatment Group | 2.4 units on a scale |