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interim analysis revealed no significant difference between study groups & increased sample size required to gain significance.
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| tamsulosin | Experimental | 0.4 mg daily for five days pre-op through post-op day one (seven total) |
|
| placebo | Placebo Comparator | One capsule daily for five days pre-op through post-op day one (seven total) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tamsulosin | Drug | 0.4 mg daily |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Postop day 1 |
| Measure | Description | Time Frame |
|---|---|---|
| Length of Hospital Stay | Length of hospital stay will be recorded in days and compared statistically between the two groups . | 1-4 days postoperative |
| Incidence of Discharge to a Skilled Nursing Facility |
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Inclusion Criteria:
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:
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| Name | Affiliation | Role |
|---|---|---|
| Andrew Urquhart, MD | University of Michigan, Dept of Orthopaedic Surgery | Principal Investigator |
| Manuel Schubert, MD | University of Michigan, Dept of Orthopaedic Surgery | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Michigan Health System | Ann Arbor | Michigan | 48109 | United States |
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Tamsulosin | 0.4 mg daily for five days pre-op through post-op day one (seven total) Tamsulosin: 0.4 mg daily |
| FG001 | Placebo | One capsule daily for five days pre-op through post-op day one (seven total) Placebo: one capsule daily |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Tamsulosin | 0.4 mg daily for five days pre-op through post-op day one (seven total) Tamsulosin: 0.4 mg daily |
| BG001 | Placebo | One capsule daily for five days pre-op through post-op day one (seven total) Placebo: one capsule daily |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Count of Participants | Participants | Postop day 1 |
|
31 days post-operatively
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Tamsulosin | 0.4 mg daily for five days pre-op through post-op day one (seven total) Tamsulosin: 0.4 mg daily |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Floppy Iris Syndrome | Eye disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| hypotension | Cardiac disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Andrew Urquhart | Michigan Medicine | 734-936-6636 | andrewu@med.umich.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 8, 2018 | Mar 13, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D000077409 | Tamsulosin |
| ID | Term |
|---|---|
| D000096926 | Benzenesulfonamides |
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
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| Placebo |
| Drug |
one capsule daily |
|
Discharge to a skilled nursing facility will be recorded (yes/no) and compared statistically between the two groups.
| 1-4 days postoperative |
| Incidence of Surgical Site Infection | Surgical site infection will be recorded (yes/no) and compared statistically between the two groups. | Up to two weeks postoperative |
| Acute Postoperative Pain Medication Dosages | The dosages of postoperative pain medications will be compared statistically between the two groups. | 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. | Up to 31 days postoperative |
| Protocol Violation |
|
| Withdrawal by Subject |
|
| Side effects |
|
| medication lost in mail |
|
| eligibility criteria no longer met |
|
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
One capsule daily for five days pre-op through post-op day one (seven total)
Placebo: one capsule daily
|
|
|
| Secondary | Length of Hospital Stay | Length of hospital stay will be recorded in days and compared statistically between the two groups . | Posted | Mean | Standard Deviation | days | 1-4 days postoperative |
|
|
|
|
| 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. | Posted | Count of Participants | Participants | 1-4 days postoperative |
|
|
|
|
| Secondary | Incidence of Surgical Site Infection | Surgical site infection will be recorded (yes/no) and compared statistically between the two groups. | Posted | Count of Participants | Participants | Up to two weeks postoperative |
|
|
|
|
| Secondary | Acute Postoperative Pain Medication Dosages | The dosages of postoperative pain medications will be compared statistically between the two groups. | Posted | Mean | Standard Deviation | morphine equivalent doses | Postoperative day 1 to day of discharge (1-4 days on average) |
|
|
|
|
| Secondary | Incidence of Postoperative Complications | Postoperative complications will be recorded and the incidence will be compared statistically between the two groups. | Posted | Count of Participants | Participants | Up to 31 days postoperative |
|
|
|
| 0 |
| 64 |
| 2 |
| 64 |
| 20 |
| 64 |
| EG001 | Placebo | One capsule daily for five days pre-op through post-op day one (seven total) Placebo: one capsule daily | 0 | 67 | 0 | 67 | 11 | 67 |
| EG002 | Not Randomized | Participants were withdrawn from study before randomization | 0 | 2 | 0 | 2 | 0 | 2 |
| Dizziness | General disorders | Systematic Assessment |
|
| Syncope | General disorders | Systematic Assessment |
|
| constipation | Gastrointestinal disorders | Systematic Assessment |
|
| increased post operative pain | Surgical and medical procedures | Systematic Assessment |
|
| delayed wound healing/wound dehiscence | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Surgical Site Infection | Infections and infestations | Systematic Assessment |
|
| Viral Infection | Infections and infestations | Systematic Assessment |
|
| Urinary Tract Infection | Infections and infestations | Systematic Assessment |
|
| Calf Pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Hives/pruritus | Immune system disorders | Systematic Assessment |
|
| Altered Mental Status | Nervous system disorders | Systematic Assessment |
|
| Shortness of Breath | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Gout Flare | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Fatigue | General disorders | Systematic Assessment |
|
| GI Bleed | Gastrointestinal disorders | Systematic Assessment |
|
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| D001555 |
| Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |