Recruiting

Sterile Water vs. Betadine

Sponsor:

University of Louisville

Code:

NCT07044726

Conditions

Catherization

Urinary Tract Infection Bacterial

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Accepted

Interventions

Povidone-Iodine

Sterile water

Study Details

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.

Conditions

Catherization

Urinary Tract Infection Bacterial

Study ID

NCT07044726

Start date

Jun 30, 2025

Status verified date

May, 2026

Completion date

May 21, 2028

Anticipated

Primary completion date

May 21, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Accepted

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

Enrollment

148 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

active comparator: Betadine

Betadine periurethral preparation

sham comparator: Sterile Water

Sterile Water periurethral preparation

Interventions

Povidone-Iodine

Providone-Iodine for periurethral preparation

Sterile water

Sterile water for periurethral preparation

Primary outcome measure

  • Bacteruria [ Time Frame: Within 2 weeks of the patients procedure date ]

Central Contacts and Locations

Central contacts

Kathryn C Seymour, MD

502-588-7660kathryn.seymour@louisville.edu

Ankita Gupta, MD, MPH

502-588-7660

Locations

UofL Physicians - Urogynecology Springs Urogynecology Office

Recruiting

Louisville, Kentucky, United States, 40205

Contacts

Kathryn Seymour, MD

502-588-7660kathryn.seymour@louisville.edu

Principal Investigator:

Ankita Gupta, MD

UofL Health - Urogynecology Mary & Elizabeth Hospital, Medical Plaza 3

Recruiting

Louisville, Kentucky, United States, 40215

Contacts

Kathryn Seymour, MD

502-588-7660kathryn.seymour@louisville.edu

Principal Investigator:

Ankita Gupta, MD

More Information

Sponsor

University of Louisville

Last update posted

May 4, 2026

Last verified

May, 2026

Keywords

  • Betadine
  • Sterile Water
  • Catherization

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Louisville on 2026-05-04.