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NCT Number: NCT07044726

Betadine vs Sterile Water for Periurethral Preparation

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.

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Key information

Conditions

Catherization Urinary Tract Infection Bacterial

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

UofL Health - Urogynecology Mary & Elizabeth Hospital, Medical Plaza 3, Louisville, Kentucky, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Povidone-Iodine

Drug

Providone-Iodine for periurethral preparation

Sterile water

Drug

Sterile water for periurethral preparation

Primary outcomes

  1. Bacteruria

    Time frame: 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 outcomes

  1. Urethral Pain

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Ankita Gupta, MD, MPH

CONTACT

502-588-7660

Kathryn C Seymour, MD

CONTACT

[email protected]

502-588-7660

Sponsors and collaborators

Lead sponsor

University of Louisville

Other

Registry information

Official study title

Betadine vs Sterile Water for Periurethral Preparation Prior to Straight Catherization in the Clinic Setting: A Randomized Controlled Trial

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Jul 1, 2025
Registry last updated
May 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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