Cytoscopic Antibiotic Irrigant to Reduce Postoperative Urinary Infection: A Randomized Controlled Study
Overview
- Phase
- Phase 4
- Intervention
- Cystoscopy
- Conditions
- Urinary Tract Infections
- Sponsor
- MetroHealth Medical Center
- Enrollment
- 242
- Locations
- 1
- Primary Endpoint
- Urinary Tract Infection
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief Summary
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.
Investigators
Jeffrey Mangel
Physician
MetroHealth Medical Center
Eligibility Criteria
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
Arms & Interventions
Standard Care
Standard cystoscopy with normal saline solution.
Intervention: Cystoscopy
Standard Care
Standard cystoscopy with normal saline solution.
Intervention: Cystoscopic Fluid/Placebo
Neosporin G. U. Irrigant
Standard cystoscopy with normal saline solution containing Neosporin® G.U. at a 1mL/1000mL concentration.
Intervention: Cystoscopic Fluid containing Neosporin G. U. Irrigant
Neosporin G. U. Irrigant
Standard cystoscopy with normal saline solution containing Neosporin® G.U. at a 1mL/1000mL concentration.
Intervention: Cystoscopy
Outcomes
Primary Outcomes
Urinary Tract Infection
Time Frame: 4 weeks
Urinary tract infection defined as positive urinalysis, urine culture, and/or positive lower urinary tract symptoms requiring antibiotic treatment.