Betadine vs Sterile Water for Periurethral Preparation
1 other identifier
interventional
148
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Jun 2025
Typical duration for phase_4
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 16, 2025
CompletedStudy Start
First participant enrolled
June 30, 2025
CompletedFirst Posted
Study publicly available on registry
July 1, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 21, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
May 21, 2028
May 4, 2026
May 1, 2026
2.9 years
June 16, 2025
May 1, 2026
Conditions
Keywords
Outcome Measures
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.
Within 2 weeks of the patients procedure date
Secondary Outcomes (1)
Urethral Pain
At the time of catherization
Study Arms (2)
Betadine
ACTIVE COMPARATORBetadine periurethral preparation
Sterile Water
SHAM COMPARATORSterile Water periurethral preparation
Interventions
Eligibility Criteria
You may qualify if:
- Aged 18+
- Patient undergoing in office straight catherization
You may not qualify if:
- 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
- rd trimester pregnancy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
UofL Physicians - Urogynecology Springs Urogynecology Office
Louisville, Kentucky, 40205, United States
UofL Health - Urogynecology Mary & Elizabeth Hospital, Medical Plaza 3
Louisville, Kentucky, 40215, United States
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ankita Gupta, MD, MPH
University of Louisville
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Fellowship Director of Urogynecology and Pelvic Reconstructive Surgery
Study Record Dates
First Submitted
June 16, 2025
First Posted
July 1, 2025
Study Start
June 30, 2025
Primary Completion (Estimated)
May 21, 2028
Study Completion (Estimated)
May 21, 2028
Last Updated
May 4, 2026
Record last verified: 2026-05
Data Sharing
- IPD Sharing
- Will not share
Individual participant data collected in this study will be used solely for the purposes of completing this study