Betadine versus sterile water for cleaning the urethra before straight catheter placement
Official title: Betadine vs Sterile Water for Periurethral Preparation Prior to Straight Catherization in the Clinic Setting: A Randomized Controlled Trial
Run by University of Louisville · NCT07044726 · Data updated 2026-11-12
This study will test whether cleaning the urethra with sterile water or Betadine changes urine bacteria and how much discomfort adults feel when they get an in‑office straight catheter.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | Women only |
| Enrollment | 148 (estimated) |
| Sponsor | University of Louisville Academic / other |
| Locations | 2 sites (Louisville, Kentucky and 1 other locations) |
| Status | Recruiting |
| Started | June 30, 2025 |
| Main results expected | May 21, 2028 |
| Study ends | May 21, 2028 |
| Registry record updated | May 4, 2026 |
| Trial ID | NCT07044726 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults aged 18 or older who are having an in‑office straight catheter placed, can consent in English, do not have recent catheterization or recurrent culture‑proven UTIs, and do not have an iodine allergy or late pregnancy are ideal candidates.
✕Probably not a fit
People with recurrent culture‑proven UTIs, positive nitrites on urinalysis, recent catheterization, iodine allergy, inability to consent, non‑English speakers, or who are in the 2nd–3rd trimester of pregnancy are not likely to be eligible or benefit from this comparison.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
Adults undergoing in‑office straight catheterization will have their urethral opening cleaned with either sterile water or povidone‑iodine (Betadine) before the catheter is placed. Researchers will compare rates of bacteria in the urine after catheterization and ask patients to rate discomfort or pain related to the procedure. People with recent catheterization, recurrent culture‑proven UTIs, positive nitrite on urinalysis, iodine allergy, inability to consent, non‑English speakers, or late pregnancy are excluded. The work is being done at University of Louisville urogynecology clinics and is a Phase 4 interventional comparison of two periurethral preparation methods.
Why it matters
Potential benefit: If successful, the finding could reduce use of chemical antiseptics or improve patient comfort by identifying a simpler, less irritating cleaning option that has similar infection outcomes.
How similar studies have gone: Povidone‑iodine is a common standard antiseptic, but there are few direct comparisons with sterile water, so this head‑to‑head question has limited prior randomized evidence.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
-
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 contacts
- Principal investigator: Ankita Gupta, MD, MPH — University of Louisville
- Study coordinator: Kathryn C Seymour, MD
- Email: kathryn.seymour@louisville.edu
- Phone: 502-588-7660
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.