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Betadine vs Sterile Water for Periurethral Preparation

University of Louisville (UOFL) logo

University of Louisville (UOFL)

Status and phase

Not yet enrolling
Phase 4

Conditions

Urinary Tract Infection Bacterial
Catherization

Treatments

Drug: Povidone-Iodine
Drug: Sterile water

Study type

Interventional

Funder types

Other

Identifiers

NCT07044726
25.0260

Details and patient eligibility

About

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.

Enrollment

148 estimated patients

Sex

Female

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

148 participants in 2 patient groups

Betadine
Active Comparator group
Description:
Betadine periurethral preparation
Treatment:
Drug: Povidone-Iodine
Sterile Water
Sham Comparator group
Description:
Sterile Water periurethral preparation
Treatment:
Drug: Sterile water

Trial documents
1

Trial contacts and locations

2

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Central trial contact

Kathryn C Seymour, MD; Ankita Gupta, MD, MPH

Data sourced from clinicaltrials.gov

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