A Phase 3 interventional study of Tamsulosin and Placebo in Postoperative Urinary Retention, sponsored by University of Michigan. Terminated at 1 site in United States. Open to male participants aged 35 Years and older. Per ClinicalTrials.gov, last updated 2019-04-12.
Sponsored by University of Michigan · Phase 3, Interventional, and Prevention
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.
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.
University of Michigan is the lead sponsor of 1,503 studies on the registry; 189 are open to participants now.
Of its 167 completed or terminated interventional studies of FDA-regulated products, 132 (79%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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
Exclusion Criteria:
0.4 mg daily for five days pre-op through post-op day one (seven total)
Drug: Tamsulosin
One capsule daily for five days pre-op through post-op day one (seven total)
Drug: Placebo
0.4 mg daily
Also known as: Flomax
one capsule daily
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
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
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
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
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)
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
| Milestone | Tamsulosin | Placebo |
|---|---|---|
| Started | 87 | 87 |
| Completed | 64 | 67 |
| Not completed | 23 | 20 |
| Withdrew: Lost to follow-up | 0 | 1 |
| Withdrew: Physician decision | 6 | 6 |
| Withdrew: Protocol violation | 6 | 4 |
| Withdrew: Withdrawal by subject | 4 | 5 |
| Withdrew: Side effects | 1 | 0 |
| Withdrew: Medication lost in mail | 0 | 1 |
| Withdrew: Eligibility criteria no longer met | 6 | 3 |
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.
| Participants | Tamsulosin | Placebo |
|---|---|---|
| Number of Patients to Develop Postoperative Urinary Retention (POUR) | 18 | 24 |
Length of hospital stay will be recorded in days and compared statistically between the two groups .
| days | Tamsulosin | Placebo |
|---|---|---|
| Length of Hospital Stay | 1.125 ± 0.42 | 1.209 ± 0.64 |
Discharge to a skilled nursing facility will be recorded (yes/no) and compared statistically between the two groups.
| Participants | Tamsulosin | Placebo |
|---|---|---|
| Incidence of Discharge to a Skilled Nursing Facility | 1 | 1 |
Surgical site infection will be recorded (yes/no) and compared statistically between the two groups.
| Participants | Tamsulosin | Placebo |
|---|---|---|
| Incidence of Surgical Site Infection | 0 | 2 |
The dosages of postoperative pain medications will be compared statistically between the two groups.
| morphine equivalent doses | Tamsulosin | Placebo |
|---|---|---|
| Acute Postoperative Pain Medication Dosages | 44.85 ± 47.18 | 36 ± 31.56 |
Postoperative complications will be recorded and the incidence will be compared statistically between the two groups.
| Participants | Tamsulosin | Placebo |
|---|---|---|
| Incidence of Postoperative Complications | 2 | 2 |
Collected over 31 days post-operatively. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Tamsulosin | 0/64 (0%) | 2/64 (3.1%) | 20/64 (31.3%) |
| Placebo | 0/67 (0%) | 0/67 (0%) | 11/67 (16.4%) |
| Not Randomized | 0/2 (0%) | 0/2 (0%) | 0/2 (0%) |
| Event | Tamsulosin | Placebo | Not Randomized |
|---|---|---|---|
| Floppy Iris SyndromeEye disorders | 2/64 | 0/67 | 0/2 |
| Event | Tamsulosin | Placebo | Not Randomized |
|---|---|---|---|
| increased post operative painSurgical and medical procedures | 5/64 | 2/67 | 0/2 |
| SyncopeGeneral disorders | 3/64 | 0/67 | 0/2 |
| Calf PainMusculoskeletal and connective tissue disorders | 3/64 | 0/67 | 0/2 |
| constipationGastrointestinal disorders | 2/64 | 1/67 | 0/2 |
| Urinary Tract InfectionInfections and infestations | 2/64 | 0/67 | 0/2 |
| hypotensionCardiac disorders | 0/64 | 2/67 | 0/2 |
| DizzinessGeneral disorders | 1/64 | 2/67 | 0/2 |
| Surgical Site InfectionInfections and infestations | 0/64 | 2/67 | 0/2 |
| Viral InfectionInfections and infestations | 1/64 | 0/67 | 0/2 |
| Hives/pruritusImmune system disorders | 1/64 | 0/67 | 0/2 |
| Age, Continuous(years) | Tamsulosin | Placebo | Total |
|---|---|---|---|
| Mean | 60.55 ± 10.4 | 61.37 ± 9.6 | 60.98 ± 9.96 |
| Sex: Female, Male(Participants) | Tamsulosin | Placebo | Total |
|---|---|---|---|
| Female | 0 | 0 | 0 |
| Male | 64 | 67 | 131 |
| Race and Ethnicity Not Collected(Participants) | Tamsulosin | Placebo | Total |
|---|---|---|---|
| Count of participants | — | — | 0 |
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Studies of the drug tested here: Tamsulosin