Betadine vs Sterile Water for Periurethral Preparation

NCT07044726 — Phase 4, Recruiting, 148 participants, University of Louisville

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

Registry	NCT07044726
Status	Recruiting
Phase	Phase 4
Study type	Interventional; randomized, parallel, masking: single, prevention
Enrollment	148 (Estimated)
Sponsor	University of Louisville (Other)
Conditions	Catherization, Urinary Tract Infection Bacterial
Interventions	Povidone-Iodine, Sterile water (Drug)
Dates	start 2025-06-30, primary completion 2028-05-21 (estimated), completion 2028-05-21 (estimated), first posted 2025-07-01, last updated 2026-05-04
Locations	2 sites in United States

-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.

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+Arms and interventions

Arm	Type	Interventions	Description
Betadine	Active comparator	Drug: Povidone-Iodine	Betadine periurethral preparation
Sterile Water	Sham comparator	Drug: Sterile water	Sterile Water periurethral preparation

Povidone-Iodine (Drug): Providone-Iodine for periurethral preparation
Sterile water (Drug): Sterile water for periurethral preparation

+Outcome measures

Primary outcomes

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 outcomes

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.

+Eligibility

Sex: Female, ages: 18 Years to any, 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

+Locations (2)

Facility	City	Country	Status
UofL Physicians - Urogynecology Springs Urogynecology Office	Louisville, Kentucky	United States	Recruiting
UofL Health - Urogynecology Mary & Elizabeth Hospital, Medical Plaza 3	Louisville, Kentucky	United States	Recruiting

+Study documents

Study Protocol and Statistical Analysis Plan (PDF, 2025-04-10)

+Investigators

Ankita Gupta, MD, MPH, Principal investigator, University of Louisville