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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

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

NCT ID

NCT03719755

First Posted

October 19, 2018

Last Updated

April 19, 2023

Sponsor

Mayo Clinic

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

Studies a U.S. FDA-regulated Device Product

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

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

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

Sniezek.Teresa@mayo.edu

First Name & Middle Initial & Last Name & Degree

Johnny Yi, MD

12. IPD Sharing Statement

Plan to Share IPD

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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