NCT07044726 Betadine vs Sterile Water for Periurethral Preparation
| NCT ID | NCT07044726 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | University of Louisville |
| Condition | Catherization |
| Study Type | INTERVENTIONAL |
| Enrollment | 148 participants |
| Start Date | 2025-06-30 |
| Primary Completion | 2028-05-21 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 148 participants in total. It began in 2025-06-30 with a primary completion date of 2028-05-21.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility 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
Contact & Investigator
Ankita Gupta, MD, MPH
PRINCIPAL INVESTIGATOR
University of Louisville
Frequently Asked Questions
Who can join the NCT07044726 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Catherization. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07044726 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT07044726 currently recruiting?
Yes, NCT07044726 is actively recruiting participants. Contact the research team at kathryn.seymour@louisville.edu for enrollment information.
Where is the NCT07044726 trial being conducted?
This trial is being conducted at Louisville, United States, Louisville, United States.
Who is sponsoring the NCT07044726 clinical trial?
NCT07044726 is sponsored by University of Louisville. The principal investigator is Ankita Gupta, MD, MPH at University of Louisville. The trial plans to enroll 148 participants.