Cytoscopic Antibiotic Irrigant to Reduce Postoperative Urinary Tract Infection

Urinary Tract Infections Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03099863
• Other study ID #: IRB15-00769
• Status: Completed
• Phase: Phase 4
• Start date: April 2016
• Est. completion date: June 2020

Study information

• Verified date: December 2021
• Source: MetroHealth Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 242
• Est. completion date: June 2020
• Est. primary completion date: June 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Communicable Diseases
• Infections
• Urinary Tract Infections

Intervention

Drug:
• Cystoscopic Fluid containing Neosporin G. U. Irrigant
Normal saline cystoscopic fluid containing Neosporin G. U. Irrigant 1mL/1000mL

Procedure:
• Cystoscopy
Diagnostic cystoscopy performed during pelvic floor surgery

Drug:
• Cystoscopic Fluid/Placebo
Normal saline cystoscopic fluid

Locations

Country	Name	City	State
United States	MetroHealth Medical Center	Cleveland	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
MetroHealth Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Urinary Tract Infection	Urinary tract infection defined as positive urinalysis, urine culture, and/or positive lower urinary tract symptoms requiring antibiotic treatment.	4 weeks