Betadine vs Sterile Water for Periurethral Preparation
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Povidone-Iodine, Sterile water.
- Who it may be relevant to
- Registry conditions: Catherization, Urinary Tract Infection Bacterial. Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Betadine vs Sterile Water for Periurethral Preparation Prior to Straight Catherization in the Clinic Setting: A Randomized Controlled Trial
Overview
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.
Interventions
- Drug Povidone-Iodine
Providone-Iodine for periurethral preparation - Drug Sterile water
Sterile water for periurethral preparation
Primary outcome measures
- Bacteruria [Time frame: Within 2 weeks of the patients procedure date]
Secondary outcome measures (1)
- Urethral Pain [Time frame: At the time of catherization]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Prevention
Study locations
United States · 2 centers
- UofL Physicians - Urogynecology Springs Urogynecology Office — Louisville
- UofL Health - Urogynecology Mary & Elizabeth Hospital, Medical Plaza 3 — Louisville
Identifiers
NCT: NCT07044726 · 25.0260