Cytoscopic Antibiotic Irrigant to Reduce Postoperative Urinary Tract Infection

Study Overview
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Brief Summary
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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.

Official Title
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Cytoscopic Antibiotic Irrigant to Reduce Postoperative Urinary Infection: A Randomized Controlled Study

Conditions
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Urinary Tract Infections

Intervention / Treatment
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* Drug: Cystoscopic Fluid containing Neosporin G. U. Irrigant
* Procedure: Cystoscopy
* Drug: Cystoscopic Fluid/Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult women at least 18 years of age Elective Female Pelvic Medicine and Reconstructive Surgery or Gynecologic Minimally Invasive surgeries including hysterectomy, suburethral sling, and pelvic organ prolapse repair that require cystoscopy. Exclusion Criteria: Surgeries that include: intradetrusor Botox, vaginal mesh excision, and fistula repair Pregnancy History of nephrolithiasis Allergy to study medications Congenital urogenital anomaly Neurogenic bladder

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Standard Care<br>Standard cystoscopy with normal saline solution. | Procedure: Cystoscopy<br>* Diagnostic cystoscopy performed during pelvic floor surgery<br>Drug: Cystoscopic Fluid/Placebo<br>* Normal saline cystoscopic fluid<br>|
| Active Comparator: Neosporin G. U. Irrigant<br>Standard cystoscopy with normal saline solution containing Neosporin® G.U. at a 1mL/1000mL concentration. | Drug: Cystoscopic Fluid containing Neosporin G. U. Irrigant<br>* Normal saline cystoscopic fluid containing Neosporin G. U. Irrigant 1mL/1000mL<br>Procedure: Cystoscopy<br>* Diagnostic cystoscopy performed during pelvic floor surgery<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 |