Betadine vs Sterile Water for Periurethral Preparation
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexFemale
Age18+
SponsorUniversity of Louisville
About this trial
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
This trial accepts healthy volunteersQualifiers
Aged 18+
Patient undergoing in office straight catherization
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Povidone-Iodine
DrugProvidone-Iodine for periurethral preparation
Sterile water
DrugSterile water for periurethral preparation
Treatment groups
148 Participants
are divided into 2 treatment groupsGroup A: BetadineActive comparator 1 intervention
Group B: Sterile WaterSham comparator 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
Within 2 weeks of the patients procedure dateSecondary outcomes
1
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.
Time frame
At the time of catherizationSponsors and contacts
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Source ClinicalTrials.gov