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Cytoscopic Antibiotic Irrigant to Reduce Postoperative Urinary Tract Infection

Primary Purpose

Urinary Tract Infections

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Cystoscopic Fluid containing Neosporin G. U. Irrigant
Cystoscopy
Cystoscopic Fluid/Placebo
Sponsored by
MetroHealth Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Urinary Tract Infections

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleAccepts 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

Sites / Locations

  • MetroHealth Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Standard Care

Neosporin G. U. Irrigant

Arm Description

Standard cystoscopy with normal saline solution.

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
March 23, 2017
Last Updated
December 1, 2021
Sponsor
MetroHealth Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT03099863
Brief Title
Cytoscopic Antibiotic Irrigant to Reduce Postoperative Urinary Tract Infection
Official Title
Cytoscopic Antibiotic Irrigant to Reduce Postoperative Urinary Infection: A Randomized Controlled Study
Study Type
Interventional

2. Study Status

Record Verification Date
December 2021
Overall Recruitment Status
Completed
Study Start Date
April 2016 (Actual)
Primary Completion Date
June 2020 (Actual)
Study Completion Date
June 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
MetroHealth Medical Center

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urinary Tract Infections

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
242 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Standard Care
Arm Type
Placebo Comparator
Arm Description
Standard cystoscopy with normal saline solution.
Arm Title
Neosporin G. U. Irrigant
Arm Type
Active Comparator
Arm Description
Standard cystoscopy with normal saline solution containing Neosporin® G.U. at a 1mL/1000mL concentration.
Intervention Type
Drug
Intervention Name(s)
Cystoscopic Fluid containing Neosporin G. U. Irrigant
Intervention Description
Normal saline cystoscopic fluid containing Neosporin G. U. Irrigant 1mL/1000mL
Intervention Type
Procedure
Intervention Name(s)
Cystoscopy
Intervention Description
Diagnostic cystoscopy performed during pelvic floor surgery
Intervention Type
Drug
Intervention Name(s)
Cystoscopic Fluid/Placebo
Intervention Description
Normal saline cystoscopic fluid
Primary Outcome Measure Information:
Title
Urinary Tract Infection
Description
Urinary tract infection defined as positive urinalysis, urine culture, and/or positive lower urinary tract symptoms requiring antibiotic treatment.
Time Frame
4 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Facility Information:
Facility Name
MetroHealth Medical Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44109
Country
United States

12. IPD Sharing Statement

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Cytoscopic Antibiotic Irrigant to Reduce Postoperative Urinary Tract Infection

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