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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Betadine | Active Comparator | Betadine periurethral preparation |
|
| Sterile Water | Sham Comparator | Sterile Water periurethral preparation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Povidone-Iodine | Drug | Providone-Iodine for periurethral preparation |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Within 2 weeks of the patients procedure date |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | At the time of catherization |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kathryn C Seymour, MD | Contact | 502-588-7660 | kathryn.seymour@louisville.edu | |
| Ankita Gupta, MD, MPH | Contact | 502-588-7660 |
| Name | Affiliation | Role |
|---|---|---|
| Ankita Gupta, MD, MPH | University of Louisville | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UofL Physicians - Urogynecology Springs Urogynecology Office | Recruiting | Louisville | Kentucky | 40205 | United States |
Individual participant data collected in this study will be used solely for the purposes of completing this study
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 10, 2025 | Jun 16, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D011206 | Povidone-Iodine |
| ID | Term |
|---|---|
| D007466 | Iodophors |
| D017613 | Iodine Compounds |
| D007287 | Inorganic Chemicals |
| D011145 | Polyvinyls |
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| Sterile water |
| Drug |
Sterile water for periurethral preparation |
|
| UofL Health - Urogynecology Mary & Elizabeth Hospital, Medical Plaza 3 | Recruiting | Louisville | Kentucky | 40215 | United States |
|
| D014753 |
| Vinyl Compounds |
| D000475 | Alkenes |
| D006839 | Hydrocarbons, Acyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011205 | Povidone |
| D011760 | Pyrrolidinones |
| D011759 | Pyrrolidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D010969 | Plastics |
| D011108 | Polymers |
| D046911 | Macromolecular Substances |
| D001697 | Biomedical and Dental Materials |
| D008420 | Manufactured Materials |
| D013676 | Technology, Industry, and Agriculture |