CatherizationPhase 4NCT07044726
Betadine vs Sterile Water for Periurethral Preparation
A Phase 4 study testing Povidone-Iodine and Sterile water in people with Catherization and Urinary Tract Infection Bacterial, run by University of Louisville at 2 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Catherization, Urinary Tract Infection Bacterial
- What is being tested?
- Povidone-Iodine and Sterile water
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 148 participants
- Where
- 2 sitesUnited States
- Study dates
- 30 Jun 2025to 21 May 2028
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Aged 18+
- Patient undergoing in office straight catherization
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Ankita Gupta, MD, MPH contact
United States2 sites, 2 recruiting
- Recruiting
UofL Physicians - Urogynecology Springs Urogynecology Office
Louisville, Kentucky, 40205
Kathryn Seymour, MD, 502-588-7660, kathryn.seymour@louisville.edu
Ankita Gupta, MD
- Recruiting
UofL Health - Urogynecology Mary & Elizabeth Hospital, Medical Plaza 3
Louisville, Kentucky, 40215
Kathryn Seymour, MD, 502-588-7660, kathryn.seymour@louisville.edu
Ankita Gupta, MD
About this study
Official title: Betadine vs Sterile Water for Periurethral Preparation Prior to Straight Catherization in the Clinic Setting: A Randomized Controlled 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.
- Conditions
- Catherization, Urinary Tract Infection Bacterial
- Being tested
- Povidone-Iodine, Sterile water
- Keywords
- Betadine, Sterile Water, Catherization
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Povidone-IodineDrug
Providone-Iodine for periurethral preparation
Sterile waterDrug
Sterile water for periurethral preparation
| Study group | Role | What they receive |
|---|---|---|
| Betadine | Active comparator | Betadine periurethral preparation Receives: Drug: Povidone-Iodine |
| Sterile Water | Sham comparator | Sterile Water periurethral preparation Receives: Drug: Sterile water |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Within 2 weeks of the patients procedure date
Secondary 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.
Measured: At the time of catherization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2025
- Study start30 Jun 2025
- Primary completion21 May 2028 (estimated)
- Study completion21 May 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CatherizationStudies of the same condition, open and under way.
- More trials run by University of LouisvilleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 148 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Louisville
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ankita Gupta, University of Louisville
- Investigators
- Ankita Gupta, MD, MPH, Principal investigator, University of Louisville
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07044726
- Sponsor's protocol ID
- 25.0260
- Status last verified
- May 2026
- First submitted
- 16 Jun 2025
- Last updated
- 4 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data collected in this study will be used solely for the purposes of completing this study
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Betadine vs Sterile Water for Periurethral Preparation Prior to Straight Catherization in the Clinic Setting: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07044726
- Acronym / sponsor ID
- 25.0260
- Conditions
- Catherization, Urinary Tract Infection Bacterial
- Keywords
- Betadine, Sterile Water, Catherization
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 148 participants (estimated)
- Lead sponsor
- University of LouisvilleUniversity, hospital or other
- Study start
- 30 Jun 2025 (actual)
- Primary completion
- 21 May 2028 (estimated)
- Study completion
- 21 May 2028 (estimated)
- First posted
- 1 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Betadine | Active comparator | Drug: Povidone-IodineBetadine periurethral preparation |
| Sterile Water | Sham comparator | Drug: Sterile waterSterile Water periurethral preparation |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Aged 18+
- Patient undergoing in office straight catherization
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Povidone-IodineProvidone-Iodine for periurethral preparation | Drug | Betadine |
| Sterile waterSterile water for periurethral preparation | Drug | Sterile Water |
Primary outcome
Bacteruria
Time frame: Within 2 weeks of the patients procedure date
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.
1 secondary outcome
Urethral Pain
Time frame: At the time of catherization
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2026.
- Individual participant dataSharing planned: No. Individual participant data collected in this study will be used solely for the purposes of completing this study
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ankita Gupta, MD, MPH contact
Ankita Gupta, MD, MPH principal investigator
University of Louisville
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Povidone-Iodine and Sterile water in people with Catherization and Urinary Tract Infection Bacterial, run by University of Louisville at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kathryn C Seymour, MD (502-588-7660, kathryn.seymour@louisville.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bacteruria (time frame: Within 2 weeks of the patients procedure date). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 May 2026.