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Urinary Tract Infections Rates Using 50% Dextrose Plus Washout Versus Normal Saline as Cystoscopy Fluid

Primary Purpose

Hysterectomy

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
50% dextrose
Normal Saline
Sponsored by
Mayo Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Hysterectomy

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Preoperative scheduling CPT codes for hysterectomy

Exclusion Criteria:

  • Discharged home with indwelling foley catheter
  • Indwelling foley catheter > 24 hours
  • Ureteral injury
  • Chronic immunosuppression
  • History of diabetes
  • Recurrent UTIs (≥2 infections in six months or ≥3 infections in one year)
  • Reported Chronic Kidney Disease
  • Renal anomalies

Sites / Locations

  • Mayo ClinicRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

50% dextrose

Normal Saline

Arm Description

Cystoscopic distention of 40 cc of 50% dextrose plus 300 cc of normal saline washout

Cystoscopic distention media of normal saline.

Outcomes

Primary Outcome Measures

rates of urinary tract infections at 6-9 days post-operative
be rates of urinary tract infections at 6-9 days post-operatively. This will be defined as a urine culture yielding greater than 100,000 gram-negative colony-forming units per milliliter

Secondary Outcome Measures

Full Information

First Posted
October 19, 2018
Last Updated
April 19, 2023
Sponsor
Mayo Clinic
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1. Study Identification

Unique Protocol Identification Number
NCT03719755
Brief Title
Urinary Tract Infections Rates Using 50% Dextrose Plus Washout Versus Normal Saline as Cystoscopy Fluid
Official Title
Comparison of Urinary Tract Infections Rates Using 50% Dextrose Plus Washout Versus Normal Saline as Cystoscopy Fluid: a Prospective Study
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 1, 2018 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
Our study will compare the rates of postoperative urinary tract infections (UTI) between patients who undergo cystoscopy using 50% dextrose injection plus bladder washout versus normal saline after hysterectomy for benign indications. Primary outcome will be rates of urinary tract infections at 6-9 days post-operatively. This will be defined as a urine culture yielding greater than 100,000 gram-negative colony-forming units per milliliter.
Detailed Description
This will be a prospective cohort study of the rate of UTIs after cystoscopic distention media of normal saline with maximum injection of 40 cc of 50% dextrose plus 300 cc of normal saline washout versus normal saline after hysterectomy for benign indications. A pre-operative urine culture will be obtained via mid-stream clean catch prior to administration of routine pre-operative prophylactic antibiotics. At 6-9 days post-operatively, a repeat urine culture will be obtained via mid-stream clean catch. Appropriate treatment will be administered if the urine culture is positive.Primary outcome will be rates of urinary tract infections at 6-9 days post-operatively. This will be defined as a urine culture yielding greater than 100,000 gram-negative colony-forming units per milliliter.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hysterectomy

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Masking Description
Subjects are blinded to distention media
Allocation
Randomized
Enrollment
140 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
50% dextrose
Arm Type
Active Comparator
Arm Description
Cystoscopic distention of 40 cc of 50% dextrose plus 300 cc of normal saline washout
Arm Title
Normal Saline
Arm Type
Placebo Comparator
Arm Description
Cystoscopic distention media of normal saline.
Intervention Type
Procedure
Intervention Name(s)
50% dextrose
Intervention Description
maximum injection of 40 cc of 50% dextrose plus 300 cc of normal saline washout versus normal saline after hysterectomy for benign indications.
Intervention Type
Procedure
Intervention Name(s)
Normal Saline
Intervention Description
Cystoscopic distention media of normal saline
Primary Outcome Measure Information:
Title
rates of urinary tract infections at 6-9 days post-operative
Description
be rates of urinary tract infections at 6-9 days post-operatively. This will be defined as a urine culture yielding greater than 100,000 gram-negative colony-forming units per milliliter
Time Frame
6-9 days post-operative

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
hysterectomy for all indications
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Preoperative scheduling CPT codes for hysterectomy Exclusion Criteria: Discharged home with indwelling foley catheter Indwelling foley catheter > 24 hours Ureteral injury Chronic immunosuppression History of diabetes Recurrent UTIs (≥2 infections in six months or ≥3 infections in one year) Reported Chronic Kidney Disease Renal anomalies
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Teresa Sniezek
Phone
480-342-0349
Email
Sniezek.Teresa@mayo.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Johnny Yi, MD
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85259
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Teresa Sniezek
Phone
480-342-0349
Email
Sniezek.Teresa@mayo.edu
First Name & Middle Initial & Last Name & Degree
Johnny Yi, MD

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
https://www.mayo.edu/research/clinical-trials
Description
Mayo Clinic Clinical Trials

Learn more about this trial

Urinary Tract Infections Rates Using 50% Dextrose Plus Washout Versus Normal Saline as Cystoscopy Fluid

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