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

NCT03719755 | Completed

• 1 other identifier: 17-000176
• Study Type: interventional
• Target: 152
• Locations: 1 country
• Sites: 1

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.

Conditions

Hysterectomy

Outcome Measures

Primary Outcomes (1)

• 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

  6-9 days post-operative

Study Arms (2)

50% dextrose

ACTIVE COMPARATOR

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

Procedure: 50% dextrose

Normal Saline

PLACEBO COMPARATOR

Cystoscopic distention media of normal saline.

Procedure: Normal Saline

Interventions

50% dextrose PROCEDURE

maximum injection of 40 cc of 50% dextrose plus 300 cc of normal saline washout versus normal saline after hysterectomy for benign indications.

50% dextrose

Normal Saline PROCEDURE

Cystoscopic distention media of normal saline

Normal Saline

Eligibility Criteria

• Gender Eligibility Details: hysterectomy for all indications
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Preoperative scheduling CPT codes for hysterectomy

You may not qualify if:

• 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

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic

Scottsdale, Arizona, 85259, United States

Location

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Interventions

Glucose; Saline Solution

Intervention Hierarchy (Ancestors)

Hexoses; Monosaccharides; Sugars; Carbohydrates; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Johnny Yi, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participant masked to distention media
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 19, 2018
• First Posted: October 25, 2018
• Study Start: February 1, 2018
• Primary Completion: December 30, 2024
• Study Completion: December 30, 2024
• Last Updated: March 30, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)