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

Study Overview
=================
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.

Official Title
-----------------
Comparison of Urinary Tract Infections Rates Using 50% Dextrose Plus Washout Versus Normal Saline as Cystoscopy Fluid: a Prospective Study

Conditions
-----------------
Hysterectomy

Intervention / Treatment
-----------------
* Procedure: 50% dextrose
* Procedure: Normal Saline


Participation Criteria
=================
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
Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 50% dextrose<br>Cystoscopic distention of 40 cc of 50% dextrose plus 300 cc of normal saline washout | Procedure: 50% dextrose<br>* maximum injection of 40 cc of 50% dextrose plus 300 cc of normal saline washout versus normal saline after hysterectomy for benign indications.<br>|
| Placebo Comparator: Normal Saline<br>Cystoscopic distention media of normal saline. | Procedure: Normal Saline<br>* Cystoscopic distention media of normal saline<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |