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Dextrose + Washout versus Normal Saline for Urinary Tract Infection
N/A
Waitlist Available
Led By Jeffrey Cornella, MD
Research Sponsored by Mayo Clinic
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6-9 days post-operative
Summary
This trial will compare UTI rates in patients who had hysterectomy with two different bladder washout solutions. Results will measure UTI rates 6-9 days after surgery.
Who is the study for?
This trial is for patients scheduled for hysterectomy without a history of diabetes, chronic kidney disease, or recurrent UTIs. It excludes those with ureteral injury, chronic immunosuppression, renal anomalies, and anyone who needs an indwelling catheter for more than 24 hours post-surgery.
What is being tested?
The study compares the effectiveness of using 50% dextrose injection plus bladder washout versus normal saline in preventing urinary tract infections after a hysterectomy. The main focus is on the number of UTIs occurring within 6-9 days post-operation.
What are the potential side effects?
Potential side effects may include discomfort from the cystoscopy fluid used during surgery. Specific side effects related to the use of dextrose or saline will be monitored and compared between groups.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6-9 days post-operative
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6-9 days post-operative
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
rates of urinary tract infections at 6-9 days post-operative
Trial Design
2Treatment groups
Active Control
Placebo Group
Group I: 50% dextroseActive Control1 Intervention
Cystoscopic distention of 40 cc of 50% dextrose plus 300 cc of normal saline washout
Group II: Normal SalinePlacebo Group1 Intervention
Cystoscopic distention media of normal saline.
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Who is running the clinical trial?
Mayo ClinicLead Sponsor
3,353 Previous Clinical Trials
3,060,883 Total Patients Enrolled
3 Trials studying Hysterectomy
170 Patients Enrolled for Hysterectomy
Jeffrey Cornella, MDPrincipal InvestigatorMayo Clinic
1 Previous Clinical Trials
4 Total Patients Enrolled
Johnny Yi, MDPrincipal InvestigatorMayo Clinic
2 Previous Clinical Trials
30 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- Injury to the tube that carries urine from the kidney to the bladder.You have a long-term weakened immune system.You have a history of diabetes.You have had two urinary tract infections in the past six months or three infections in the past year.You have a history of long-term kidney disease.Kidney problemsYou were sent home with a tube in your body to help you pee.You have a urinary catheter that has been in place for more than 24 hours.
Research Study Groups:
This trial has the following groups:- Group 1: 50% dextrose
- Group 2: Normal Saline
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.