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

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Mayo Clinic

Status

Completed

Conditions

Hysterectomy

Treatments

Procedure: Normal Saline
Procedure: 50% dextrose

Study type

Interventional

Funder types

Other

Identifiers

NCT03719755
17-000176

Details and patient eligibility

About

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.

Full 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.

Enrollment

152 patients

Sex

Female

Volunteers

No 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

Trial design

Primary purpose

Diagnostic

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

152 participants in 2 patient groups, including a placebo group

50% dextrose
Active Comparator group
Description:
Cystoscopic distention of 40 cc of 50% dextrose plus 300 cc of normal saline washout
Treatment:
Procedure: 50% dextrose
Normal Saline
Placebo Comparator group
Description:
Cystoscopic distention media of normal saline.
Treatment:
Procedure: Normal Saline

Trial contacts and locations

1

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Central trial contact

Teresa Sniezek

Data sourced from clinicaltrials.gov

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