A Phase 4 interventional study of Povidone-Iodine and Sterile water in Catherization and Urinary Tract Infection Bacterial, sponsored by University of Louisville. Recruiting at 2 sites in United States. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-05-04.
Sponsored by University of Louisville · Phase 4, Interventional, and Prevention
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.
University of Louisville is the lead sponsor of 284 studies on the registry; 53 are open to participants now.
Of its 20 completed or terminated interventional studies of FDA-regulated products, 7 (35%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Betadine periurethral preparation
Drug: Povidone-Iodine
Sterile Water periurethral preparation
Drug: Sterile water
Providone-Iodine for periurethral preparation
Sterile water for periurethral preparation
Bacteruria
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.
Time frame: Within 2 weeks of the patients procedure date
Urethral Pain
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.
Time frame: At the time of catherization
Documents are hosted by the registry — open the source record to download them.
Plan to share: No — Individual participant data collected in this study will be used solely for the purposes of completing this study
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