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

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ClinicalTrials.gov Identifier: NCT03719755
Recruitment Status : Recruiting
First Posted : October 25, 2018
Last Update Posted : October 25, 2018
Sponsor:
Information provided by (Responsible Party):
Jeffrey L. Cornella, Mayo Clinic

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.

Condition or disease Intervention/treatment Phase
Hysterectomy Procedure: 50% dextrose Procedure: Normal Saline Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 140 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Masking Description: Subjects are blinded to distention media
Primary Purpose: Diagnostic
Official Title: Comparison of Urinary Tract Infections Rates Using 50% Dextrose Plus Washout Versus Normal Saline as Cystoscopy Fluid: a Prospective Study
Actual Study Start Date : February 1, 2018
Estimated Primary Completion Date : May 2019
Estimated Study Completion Date : May 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Dextrose

Arm Intervention/treatment
Active Comparator: 50% dextrose
Cystoscopic distention of 40 cc of 50% dextrose plus 300 cc of normal saline washout
Procedure: 50% dextrose
maximum injection of 40 cc of 50% dextrose plus 300 cc of normal saline washout versus normal saline after hysterectomy for benign indications.

Placebo Comparator: Normal Saline
Cystoscopic distention media of normal saline.
Procedure: Normal Saline
Cystoscopic distention media of normal saline




Primary Outcome Measures :
  1. rates of urinary tract infections at 6-9 days post-operative [ Time Frame: 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



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   hysterectomy for benign indications
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03719755


Contacts
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Contact: Heather Crowe 480-342-3987 Crowe.Heather1@mayo.edu

Locations
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United States, Arizona
Mayo Clinic Recruiting
Scottsdale, Arizona, United States, 85259
Contact: Heather Crowe    480-342-3987    Crowe.Heather1@mayo.edu   
Principal Investigator: Jeffrey Cornella, MD         
Sponsors and Collaborators
Mayo Clinic
Investigators
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Principal Investigator: Jeffrey Cornella, MD Mayo Clinic

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Responsible Party: Jeffrey L. Cornella, Principal Investigator, Mayo Clinic
ClinicalTrials.gov Identifier: NCT03719755     History of Changes
Other Study ID Numbers: 17-000176
First Posted: October 25, 2018    Key Record Dates
Last Update Posted: October 25, 2018
Last Verified: October 2018

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

Additional relevant MeSH terms:
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Urinary Tract Infections
Infection
Urologic Diseases