Cytoscopic Antibiotic Irrigant to Reduce Postoperative Urinary Tract Infection

Phase 4

Completed

• Conditions: Urinary Tract Infections
• Interventions: Procedure: Cystoscopy; Drug: Cystoscopic Fluid containing Neosporin G. U. Irrigant; Drug: Cystoscopic Fluid/Placebo

• Registration Number: NCT03099863
• Lead Sponsor: MetroHealth Medical Center

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-04
• Study First Submitted: 2017-03-23
• Study First Submitted QC: 2017-04-03
• Study First Posted: 2017-04-04
• Primary Completion: 2020-06
• Study Completion: 2020-06
• Results First Submitted: 2021-10-18
• Status Verified: 2021-12
• Results First Submitted QC: 2021-12-01
• Last Update Submitted: 2021-12-01
• Results First Posted: 2021-12-30
• Last Update Posted: 2021-12-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 242

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.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard Care	Cystoscopy	Standard cystoscopy with normal saline solution.
Neosporin G. U. Irrigant	Cystoscopic Fluid containing Neosporin G. U. Irrigant	Standard cystoscopy with normal saline solution containing Neosporin® G.U. at a 1mL/1000mL concentration.
Standard Care	Cystoscopic Fluid/Placebo	Standard cystoscopy with normal saline solution.
Neosporin G. U. Irrigant	Cystoscopy	Standard cystoscopy with normal saline solution containing Neosporin® G.U. at a 1mL/1000mL concentration.

Primary Outcome Measures

Name	Time	Method
Urinary Tract Infection	4 weeks	Urinary tract infection defined as positive urinalysis, urine culture, and/or positive lower urinary tract symptoms requiring antibiotic treatment.

Trial Locations

Locations (1)

MetroHealth Medical Center; 🇺🇸 Cleveland, Ohio, United States