Betadine vs Sterile Water for Periurethral Preparation
Part of paid clinical trials in Louisville, Kentucky.
- Sponsor
- University of Louisville
- Study ID
- NCT07044726
- Phase
- PHASE4
- Status
- Recruiting
Conditions
- Catherization
- Urinary Tract Infection Bacterial
Eligibility Criteria
- Sex
- FEMALE
- Age
- 18 Years - N/A
- Healthy Volunteers
- Accepted
Interventions
- Povidone-Iodine — DRUGProvidone-Iodine for periurethral preparation
- Sterile water — DRUGSterile water for periurethral preparation
Study Details
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.
Key Dates
- Start date
- Jun 30, 2025
- Status verified
- May 2026
- Primary completion
- May 21, 2028
- Completion
- May 21, 2028
Study Design
- Enrollment
- 148 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- PREVENTION
Arms
- Active Comparator: BetadineBetadine periurethral preparation
- Sham Comparator: Sterile WaterSterile Water periurethral preparation
Primary Outcome Measure
Bacteruria [ Time Frame: Within 2 weeks of the patients procedure date ]
Central Contacts
- Kathryn C Seymour, MD502-588-7660
- Ankita Gupta, MD, MPH502-588-7660
Locations (2)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| UofL Health - Urogynecology Mary & Elizabeth Hospital, Medical Plaza 3 | Louisville | Kentucky | 40215 | Ankita Gupta, MD (PRINCIPAL_INVESTIGATOR) |
| UofL Physicians - Urogynecology Springs Urogynecology Office | Louisville | Kentucky | 40205 | Ankita Gupta, MD (PRINCIPAL_INVESTIGATOR) |