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Postoperative urinary tract infections (UTIs) affect 20-30% of patients undergoing elective gynecologic surgery and have a significant socioeconomic impact and cost. Preoperative antibiotics, sterile operating techniques, postoperative antibiotic and non-antibiotic medical therapies have been utilized to attempt to decrease this rate with little improvement. Utilization of an intraoperative antibiotic cystoscopic irrigant may decrease postoperative UTIs. The investigators have designed a prospective randomized controlled study to evaluate the effectiveness of an antibiotic cystoscopic fluid in preventing postoperative urinary tract infections in women undergoing elective pelvic floor surgery with cystoscopy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard Care | Placebo Comparator | Standard cystoscopy with normal saline solution. |
|
| Neosporin G. U. Irrigant | Active Comparator | Standard cystoscopy with normal saline solution containing Neosporin® G.U. at a 1mL/1000mL concentration. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cystoscopic Fluid containing Neosporin G. U. Irrigant | Drug | Normal saline cystoscopic fluid containing Neosporin G. U. Irrigant 1mL/1000mL |
|
| Measure | Description | Time Frame |
|---|---|---|
| Urinary Tract Infection | Urinary tract infection defined as positive urinalysis, urine culture, and/or positive lower urinary tract symptoms requiring antibiotic treatment. | 4 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| MetroHealth Medical Center | Cleveland | Ohio | 44109 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Standard Care | Standard cystoscopy with normal saline solution. Cystoscopy: Diagnostic cystoscopy performed during pelvic floor surgery Cystoscopic Fluid/Placebo: Normal saline cystoscopic fluid |
| FG001 | Neosporin G. U. Irrigant | Standard cystoscopy with normal saline solution containing Neosporin® G.U. at a 1mL/1000mL concentration. Cystoscopic Fluid containing Neosporin G. U. Irrigant: Normal saline cystoscopic fluid containing Neosporin G. U. Irrigant 1mL/1000mL Cystoscopy: Diagnostic cystoscopy performed during pelvic floor surgery |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Standard Care | Standard cystoscopy with normal saline solution. Cystoscopy: Diagnostic cystoscopy performed during pelvic floor surgery Cystoscopic Fluid/Placebo: Normal saline cystoscopic fluid |
| BG001 | Neosporin G. U. Irrigant |
| 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 | Urinary Tract Infection | Urinary tract infection defined as positive urinalysis, urine culture, and/or positive lower urinary tract symptoms requiring antibiotic treatment. | Posted | Number | 80% Confidence Interval | UTI | 4 weeks |
|
6 weeks
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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 | Standard Care | Standard cystoscopy with normal saline solution. Cystoscopy: Diagnostic cystoscopy performed during pelvic floor surgery Cystoscopic Fluid/Placebo: Normal saline cystoscopic fluid |
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Our primary limitation is the failure to reach statistical power based on the lower than expected incidence of UTI. Additionally, our patient cohort had a wide variation in surgical approach and techniques, which have different UTI risks at baseline. The total cohort is underpowered to identify differences in any one procedure type, such as vaginal reconstruction or mid-urethral slings.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Jeffrey Mangel | MetroHealth Medical Center | 2167784444 | jmangel@metrohealth.org |
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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 30, 2020 | Nov 30, 2021 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D014552 | Urinary Tract Infections |
| ID | Term |
|---|---|
| D007239 | Infections |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| ID | Term |
|---|---|
| D003558 | Cystoscopy |
| ID | Term |
|---|---|
| D004724 | Endoscopy |
| D003949 | Diagnostic Techniques, Surgical |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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| Cystoscopy | Procedure | Diagnostic cystoscopy performed during pelvic floor surgery |
|
| Cystoscopic Fluid/Placebo | Drug | Normal saline cystoscopic fluid |
|
Standard cystoscopy with normal saline solution containing Neosporin® G.U. at a 1mL/1000mL concentration.
Cystoscopic Fluid containing Neosporin G. U. Irrigant: Normal saline cystoscopic fluid containing Neosporin G. U. Irrigant 1mL/1000mL
Cystoscopy: Diagnostic cystoscopy performed during pelvic floor surgery
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | All participants were analyzed | Number | participants |
|
| Region of Enrollment | Number | participants |
|
| Surgery Type (patients could have more than 1 procedure) | Number | participants |
|
|
|
| 0 |
| 111 |
| 0 |
| 111 |
| 0 |
| 111 |
| EG001 | Neosporin G. U. Irrigant | Standard cystoscopy with normal saline solution containing Neosporin® G.U. at a 1mL/1000mL concentration. Cystoscopic Fluid containing Neosporin G. U. Irrigant: Normal saline cystoscopic fluid containing Neosporin G. U. Irrigant 1mL/1000mL Cystoscopy: Diagnostic cystoscopy performed during pelvic floor surgery | 0 | 105 | 0 | 105 | 0 | 105 |
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| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D003950 | Diagnostic Techniques, Urological |
| D019060 | Minimally Invasive Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D013520 | Urologic Surgical Procedures |
| D013519 | Urogenital Surgical Procedures |