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The purpose of this study is to evaluate whether taking prophylactic (preventative) antibiotics at the time of standard of care clinic-based urethral bulking reduces the risk of post-procedural urinary tract infection (UTI).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Prophylactic Antibiotic Group | Experimental | Participants in this group will receive a single oral dose of either Bactrim (800 mg sulfamethoxazole + 160 mg trimethoprim) or if allergic to sulfonamides, a single oral dose of Macrobid (100 mg nitrofurantoin) at the time of standard of care clinic based urethral bulking procedure. |
|
| No Prophylactic Antibiotic Group | No Intervention | Participants in this group will not receive prophylactic antibiotics at the time of standard of care clinic based urethral bulking procedure. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bactrim (800/160 mg) or Macrobid (100mg) | Drug | Participants will receive a single oral dose of either Bactrim (800 mg sulfamethoxazole + 160 mg trimethoprim) or if allergic to sulfonamides, a single oral dose of Macrobid (100 mg nitrofurantoin) at the time of the urethral bulking procedure. |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of post-procedural urinary tract infection (UTI) within six weeks following urethral bulking procedure | The occurrence of urinary tract infection (UTI) within 6 weeks post-procedure will be compared between patients who receive prophylactic oral antibiotics administered in clinic at the time of urethral bulking and those who do not receive antibiotic prophylaxis. UTI will be defined by clinical diagnosis documented in the medical record, with or without supporting urine culture results. | 6 Weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Katherine Amin, MD | Contact | (305) 243-6590 | katherine.amin@med.miami.edu | |
| Elena Cortizas, MS | Contact | (305) 243-3593 | ecortizas@med.miami.edu |
| Name | Affiliation | Role |
|---|---|---|
| Katherine Amin, MD | University of Miami | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Desai Sethi Urology Institute | Miami | Florida | 33136 | United States |
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| ID | Term |
|---|---|
| D014552 | Urinary Tract Infections |
| D014550 | Urinary Incontinence, Stress |
| D014549 | Urinary Incontinence |
| ID | Term |
|---|---|
| D007239 | Infections |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| ID | Term |
|---|---|
| D015662 | Trimethoprim, Sulfamethoxazole Drug Combination |
| D009582 | Nitrofurantoin |
| D013420 | Sulfamethoxazole |
| D014295 | Trimethoprim |
| ID | Term |
|---|---|
| D000096926 | Benzenesulfonamides |
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
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|
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| University of Miami Hospitals and Clinics | Miami | Florida | 33136 | United States |
|
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D014555 | Urination Disorders |
| D059411 | Lower Urinary Tract Symptoms |
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D013424 |
| Sulfanilamides |
| D000814 | Aniline Compounds |
| D000588 | Amines |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D004338 | Drug Combinations |
| D004364 | Pharmaceutical Preparations |
| D009581 | Nitrofurans |
| D009574 | Nitro Compounds |
| D005663 | Furans |