Postoperative Urinary Retention
Conditions
Brief summary
The study aims to evaluate the efficacy of prophylactic tamsulosin in reducing the incidence of postoperative urinary retention in primary total knee and hip arthroplasty patients.
Detailed description
Prophylactic administration of tamsulosin will be compared to a placebo to evaluate the effectiveness in reducing the incidence of postoperative urinary retention in total hip and knee arthroplasty patients.
Interventions
DRUGTamsulosin
0.4 mg daily
DRUGPlacebo
one capsule daily
Sponsors
University of Michigan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
MALE
Age
35 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Men age 35 or older * Primary total hip and knee arthroplasty patients (general, spinal, or epidural anesthesia * No current use (\>1 month) of alpha-blockers * Community ambulator * Adequate organ and marrow function as defined below: leucocytes at least 3,000/µL, absolute neutrophil count at least 1,500/µL, platelets at least 100,000/µL, creatinine within normal institutional limits * Ability to understand, and the willingness to sign, a written informed consent
Exclusion criteria
* History of radical prostatectomy * Receiving any other investigational agents * Revision hip and knee arthroplasty patients * Severe liver or kidney disease * Taking strong inhibitors of CYP3A4 (ketoconazole, itraconazole, clarithromycin, ritonavir, indinavir/ritonavir, lopinavir, or conivaptan) * Being on alpha-blockers (alfuzosin, doxazosin, prazosin, terazosin, tamsulosin, phenoxybenzamine, or silodosin) * Being of 5-alpha reductase inhibitors (finasteride, dutasteride) * History of allergy or sensitivity to tamsulosin or other alpha-blockers (alfuzosin, doxazosin, prazosin, terazosin, or phenoxybenzamine) * Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements * Taking Sildenafil,Tadalafil, or Vardenafil
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Patients to Develop Postoperative Urinary Retention (POUR) | Postop day 1 | Patients who have not developed POUR will have two consecutive, spontaneous urine voids with residual volume of less than 200 mL, as determined by bladder scan or straight catheterization. Patients who do not successfully have the two spontaneous urine voids of less than 200 mL will be considered as having developed POUR. The incidence of POUR will be compared statistically between those taking and not taking tamsulosin at the time of surgery. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Length of Hospital Stay | 1-4 days postoperative | Length of hospital stay will be recorded in days and compared statistically between the two groups . |
| Incidence of Discharge to a Skilled Nursing Facility | 1-4 days postoperative | Discharge to a skilled nursing facility will be recorded (yes/no) and compared statistically between the two groups. |
| Incidence of Surgical Site Infection | Up to two weeks postoperative | Surgical site infection will be recorded (yes/no) and compared statistically between the two groups. |
| Acute Postoperative Pain Medication Dosages | Postoperative day 1 to day of discharge (1-4 days on average) | The dosages of postoperative pain medications will be compared statistically between the two groups. |
| Incidence of Postoperative Complications | Up to 31 days postoperative | Postoperative complications will be recorded and the incidence will be compared statistically between the two groups. |
Countries
United States
Participant flow
Pre-assignment details
176 subjects were enrolled in the study. 174 were randomized to either the active tamsulosin group or placebo group and 2 subjects were withdrawn prior to randomization. 43 additional patients were withdrawn after randomization.
Participants by arm
| Arm | Count |
|---|---|
| Tamsulosin 0.4 mg daily for five days pre-op through post-op day one (seven total)
Tamsulosin: 0.4 mg daily | 64 |
| Placebo One capsule daily for five days pre-op through post-op day one (seven total)
Placebo: one capsule daily | 67 |
| Total | 131 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | eligibility criteria no longer met | 6 | 3 |
| Overall Study | Lost to Follow-up | 0 | 1 |
| Overall Study | medication lost in mail | 0 | 1 |
| Overall Study | Physician Decision | 6 | 6 |
| Overall Study | Protocol Violation | 6 | 4 |
| Overall Study | Side effects | 1 | 0 |
| Overall Study | Withdrawal by Subject | 4 | 5 |
Baseline characteristics
| Characteristic | Tamsulosin | Placebo | Total |
|---|---|---|---|
| Age, Continuous | 60.55 years STANDARD_DEVIATION 10.4 | 61.37 years STANDARD_DEVIATION 9.6 | 60.98 years STANDARD_DEVIATION 9.96 |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 64 Participants | 67 Participants | 131 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 64 | 0 / 67 | 0 / 2 |
| other Total, other adverse events | 20 / 64 | 11 / 67 | 0 / 2 |
| serious Total, serious adverse events | 2 / 64 | 0 / 67 | 0 / 2 |
Outcome results
Primary
Number of Patients to Develop Postoperative Urinary Retention (POUR)
Patients who have not developed POUR will have two consecutive, spontaneous urine voids with residual volume of less than 200 mL, as determined by bladder scan or straight catheterization. Patients who do not successfully have the two spontaneous urine voids of less than 200 mL will be considered as having developed POUR. The incidence of POUR will be compared statistically between those taking and not taking tamsulosin at the time of surgery.
Time frame: Postop day 1
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Tamsulosin | Number of Patients to Develop Postoperative Urinary Retention (POUR) | 18 Participants |
| Placebo | Number of Patients to Develop Postoperative Urinary Retention (POUR) | 24 Participants |
p-value: 0.345Chi-squared
Secondary
Acute Postoperative Pain Medication Dosages
The dosages of postoperative pain medications will be compared statistically between the two groups.
Time frame: Postoperative day 1 to day of discharge (1-4 days on average)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Tamsulosin | Acute Postoperative Pain Medication Dosages | 44.85 morphine equivalent doses | Standard Deviation 47.18 |
| Placebo | Acute Postoperative Pain Medication Dosages | 36 morphine equivalent doses | Standard Deviation 31.56 |
p-value: 0.207Student T-test
Secondary
Incidence of Discharge to a Skilled Nursing Facility
Discharge to a skilled nursing facility will be recorded (yes/no) and compared statistically between the two groups.
Time frame: 1-4 days postoperative
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Tamsulosin | Incidence of Discharge to a Skilled Nursing Facility | 1 Participants |
| Placebo | Incidence of Discharge to a Skilled Nursing Facility | 1 Participants |
p-value: 1Fisher Exact
Secondary
Incidence of Postoperative Complications
Postoperative complications will be recorded and the incidence will be compared statistically between the two groups.
Time frame: Up to 31 days postoperative
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Tamsulosin | Incidence of Postoperative Complications | 2 Participants |
| Placebo | Incidence of Postoperative Complications | 2 Participants |
Secondary
Incidence of Surgical Site Infection
Surgical site infection will be recorded (yes/no) and compared statistically between the two groups.
Time frame: Up to two weeks postoperative
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Tamsulosin | Incidence of Surgical Site Infection | 0 Participants |
| Placebo | Incidence of Surgical Site Infection | 2 Participants |
p-value: 0.497Fisher Exact
Secondary
Length of Hospital Stay
Length of hospital stay will be recorded in days and compared statistically between the two groups .
Time frame: 1-4 days postoperative
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Tamsulosin | Length of Hospital Stay | 1.125 days | Standard Deviation 0.42 |
| Placebo | Length of Hospital Stay | 1.209 days | Standard Deviation 0.64 |
p-value: 0.378Student T-Test