Cytoscopic Antibiotic Irrigant to Reduce Postoperative Urinary Tract Infection

MetroHealth Medical Center

Status and phase: Completed; Phase 4

Conditions: Urinary Tract Infections

Treatments: Drug: Cystoscopic Fluid/Placebo; Drug: Cystoscopic Fluid containing Neosporin G. U. Irrigant; Procedure: Cystoscopy

Study type: Interventional

Funder types: Other

Identifiers

NCT03099863

IRB15-00769

Details and patient eligibility

About

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.

Enrollment: 242 patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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242 participants in 2 patient groups, including a placebo group

Standard Care

Placebo Comparator group

Description:

Standard cystoscopy with normal saline solution.

Treatment:

Drug: Cystoscopic Fluid/Placebo

Procedure: Cystoscopy

Neosporin G. U. Irrigant

Active Comparator group

Description:

Standard cystoscopy with normal saline solution containing Neosporin® G.U. at a 1mL/1000mL concentration.

Treatment:

Drug: Cystoscopic Fluid containing Neosporin G. U. Irrigant

Procedure: Cystoscopy