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Lack of enrollment
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This randomized open-label study will be comprised of 2 cohorts: one control group and one treatment group. The trial will be conducted as an open label randomized trial to evaluate the efficacy of tamsulosin in the prevention of post-operative urinary retention. The study will include pre- and post-surgical evaluations of patients including symptoms of urinary retention and any adverse effects contributable to the study medication.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tamsulosin Group | Experimental | Subjects will receive:
|
|
| Education Group | Active Comparator | Subjects will receive: 1) education about signs and symptoms of urinary retention |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tamsulosin | Drug | Tamsulosin may have prophylactic properties against post-operative urinary retention |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Post-operative Urinary Retention | 5 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Edward E. Messing, MD | University of Rochester | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Rochester | Rochester | New York | 14642 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Tamsulosin Group | Subjects will receive:
Tamsulosin: Tamsulosin may have prophylactic properties against post-operative urinary retention Education: Education about signs and symptoms of urinary retention |
| FG001 | Education Group | Subjects will receive: 1) education about signs and symptoms of urinary retention Education: Education about signs and symptoms of urinary retention |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Tamsulosin Group | Subjects will receive:
Tamsulosin: Tamsulosin may have prophylactic properties against post-operative urinary retention Education: Education about signs and symptoms of urinary retention |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 Participants With Post-operative Urinary Retention | Posted | Count of Participants | Participants | 5 days |
|
1 month
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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 Group | Subjects will receive:
Tamsulosin: Tamsulosin may have prophylactic properties against post-operative urinary retention Education: Education about signs and symptoms of urinary retention |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Edward Messing | University of Rochester | 585 - 275 - 0998 | edward_messing@urmc.rochester.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 | Aug 9, 2016 | Dec 28, 2018 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D000077409 | Tamsulosin |
| D004522 | Educational Status |
| ID | Term |
|---|---|
| D000096926 | Benzenesulfonamides |
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
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| Education | Other | Education about signs and symptoms of urinary retention |
|
| BG001 | Education Group | Subjects will receive: 1) education about signs and symptoms of urinary retention Education: Education about signs and symptoms of urinary retention |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| 0 |
| 1 |
| 0 |
| 1 |
| 0 |
| 1 |
| EG001 | Education Group | Subjects will receive: 1) education about signs and symptoms of urinary retention Education: Education about signs and symptoms of urinary retention | 0 | 4 | 0 | 4 | 0 | 4 |
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| D001555 |
| Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D012959 | Socioeconomic Factors |
| D011154 | Population Characteristics |