Purpose

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.

Conditions

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
Female
Accepts 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

Study Design

Phase
Phase 4
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Prevention
Masking
Single (Participant)

Arm Groups

ArmDescriptionAssigned Intervention
Active Comparator
Betadine
Betadine periurethral preparation
  • Drug: Povidone-Iodine
    Providone-Iodine for periurethral preparation
Sham Comparator
Sterile Water
Sterile Water periurethral preparation
  • Drug: Sterile water
    Sterile water for periurethral preparation

Recruiting Locations

UofL Physicians - Urogynecology Springs Urogynecology Office
Louisville, Kentucky 40205
Contact:
Kathryn Seymour, MD
502-588-7660
kathryn.seymour@louisville.edu

UofL Health - Urogynecology Mary & Elizabeth Hospital, Medical Plaza 3
Louisville, Kentucky 40215
Contact:
Kathryn Seymour, MD
502-588-7660
kathryn.seymour@louisville.edu

More Details

Status
Recruiting
Sponsor
University of Louisville

Study Contact

Kathryn C Seymour, MD
502-588-7660
kathryn.seymour@louisville.edu

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.