Catherization, Urinary Tract Infection Bacterial
Conditions
Keywords
Betadine, Sterile Water, Catherization
Brief summary
The purpose of this study is to determine whether cleaning of the urethra, or external opening to the bladder, with sterile water (water that has been treated to remove bacteria and living organisms) vs Betadine also known as Povidone-Iodine (a medical grade cleaning solution) changes the rates of bacteria in the urine after a temporary catheter, or draining tube, is placed into the bladder. Chemical antiseptics, including Betadine, are the current standard of care. An additional goal of this study is to determine whether cleaning of the urethra, or external opening to the bladder, with sterile water vs betadine changes the amount of discomfort or pain patients experience with placement of a temporary catheter, or draining tube, in the bladder.
Interventions
DRUGPovidone-Iodine
Providone-Iodine for periurethral preparation
DRUGSterile water
Sterile water for periurethral preparation
Sponsors
University of Louisville
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Aged 18+ * Patient undergoing in office straight catherization
Exclusion criteria
* History of culture proven recurrent urinary tract infection (2 in any 6-month period or 3 in any 12-month period) * Urine Analysis with +Nitrites * Catherization for any reason in the last 4 weeks * History of Iodine allergy * Patients unable to speak English * Patient does not have the capacity to consent * 2-3rd trimester pregnancy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Bacteruria | Within 2 weeks of the patients procedure date | Bacteruria defined as the presence of bacteria within patient urine evaluated with urinalysis. Bacterial presence will be further characterized by colony forming unit count on urine culture. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Urethral Pain | At the time of catherization | Urethral pain at the time of catheterization rated by patients on a visual analog scale zero to ten with zero representing no pain and ten representing the worst pain of their life. |
Countries
United States
Contacts
CONTACTKathryn C Seymour, MD
CONTACTAnkita Gupta, MD, MPH
PRINCIPAL_INVESTIGATORAnkita Gupta, MD, MPH
University of Louisville
Outcome results
None listed