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The goal of this clinical trial is to evaluate if prophylactic antibiotics in urethral bulking are effective in reducing postprocedural urinary tract infections.
Urethral bulking is a minimally invasive surgical treatment option for stress urinary incontinence (SUI). One commonly reported post-procedural complication is urinary tract infection (UTI). UTI rates are variable where studies have reported rates from as low as 0% to as high as 40%. Along with this variability, the instructional inserts for various bulking agents have inconsistent recommendations for use of prophylactic antibiotics. The American Urologic Association recommends antimicrobial prophylaxis for cystourethroscopy procedures involving minor manipulation. Currently, there are no clear guidelines regarding the utility of prophylactic antibiotics for urethral bulking. The objective of our study is to determine the effectiveness of prophylactic antibiotics in urethral bulking for reducing post procedural UTIs.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Antibiotic Group | Experimental | Those randomized to this group will receive a one-time dose of an oral antibiotic prior to the urethral bulking procedure. The antibiotic will be based on the participants' allergies, medical history, and current medication list. |
|
| No antibiotic group | Other | Those randomized to this group will not receive an antibiotic prior to the urethral bulking procedure. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Prophylactic antibiotics | Other | These participants will be given a single dose of an oral antibiotic prior to the procedure. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Rate of urinary tract infection (UTI) | The rate of UTI based on symptoms and a positive urine culture | Within 4 weeks after the procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of postoperative urinary retention | The rate of postoperative urinary retention | Within 4 weeks after the procedure |
| Rates of other postoperative complications | The rate of other complications (bleeding, discomfort, etc) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Tess Gao, MD | Contact | 973-971-7267 | tess.gao@atlantichealth.org |
| Name | Affiliation | Role |
|---|---|---|
| Erika Wasenda, MD | Atlantic Health System | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Atlantic Health | Recruiting | Morristown | New Jersey | 07960 | United States |
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| ID | Term |
|---|---|
| D014550 | Urinary Incontinence, Stress |
| ID | Term |
|---|---|
| D014549 | Urinary Incontinence |
| D014555 | Urination Disorders |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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| No antibiotics | Other | These participants will not be given an antibiotic prior to the procedure. |
|
| Within 4 weeks after the procedure |
| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D059411 | Lower Urinary Tract Symptoms |
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |