Urinary Tract InfectionNCT07239219
The Impact of Irrisept in Reducing Urinary Tract Infection During Urethral Catheter Removal.
A study testing 0.05% Chlorhexidine Gluconate and Normal Saline in people with Urinary Tract Infection and Antibiotic, run by Ohio State University at 1 site in United States.
Trial summary
Given the high burden of post-catheter removal UTIs, this study aims to evaluate Irrisept instillation as a non-antibiotic intervention to reduce infection rates. By comparing Irrisept to saline irrigation, the study will provide critical insights into the efficacy of antiseptic bladder irrigation in preventing UTIs… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Urinary Tract Infection, Antibiotic, Catheter Infection
- What is being tested?
- 0.05% Chlorhexidine Gluconate and Normal Saline
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2026to 1 Jan 2028
- Phase
- Interventional
- 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
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Presenting to the urology clinic for catheter removal
- Must be 18 years or older.
- The patient must be able to understand and willing to provide informed consent as described in this study protocol.
- Must be willing to complete a post-catheter removal survey
Who cannot join
- Allergy or adverse reaction to chlorohexidine gluconate
- Under the age of 18
- Refuse to provide informed consent
- On antibiotic therapy for any indication.
- Women who are pregnant or breastfeeding
- Signs of skin or systemic infection
- Patients undergoing catheter exchange
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
The Ohio State University
Columbus, Ohio, 43212-3153
Hiren Patel, MD, PhD, 6142938155, hiren.patel@osumc.edu
About this study
Official title: To Determine the Efficacy of Irrisept in Reducing Urinary Tract Infection During Urethral Catheter Removal.
Given the high burden of post-catheter removal UTIs, this study aims to evaluate Irrisept instillation as a non-antibiotic intervention to reduce infection rates. By comparing Irrisept to saline irrigation, the study will provide critical insights into the efficacy of antiseptic bladder irrigation in preventing UTIs while minimizing antibiotic use. If successful, this approach could lead to new clinical guidelines for catheter removal protocols, improving patient outcomes and reducing healthcare costs.
- Conditions
- Urinary Tract Infection, Antibiotic, Catheter Infection
- Being tested
- 0.05% Chlorhexidine Gluconate, Normal Saline
- Keywords
- UTI, antibiotic, Catheter infection, CAUTI
- Medical subject headings
- Urinary Tract Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
0.05% Chlorhexidine GluconateOther
0.05% CHG is instilled into the bladder prior to trial of void.
Normal SalineOther
Bladder is back filled with normal saline.
| Study group | Role | What they receive |
|---|---|---|
| Control | Active comparator | Standard of care Receives: Other: Normal Saline |
| Experimental | Experimental | Experimental Receives: Other: 0.05% Chlorhexidine Gluconate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Urinary tract infection
Evaluate the rate of urinary tract infection after urethral catheter removal.
Measured: 30 days
Secondary outcomes (2)
Antibiotic use
Evaluate the rates of antibiotic use 30 days after urethral catheter removal
Measured: 30 days
Adverse Events
Evaluate the rates of adverse events 30 days after urethral catheter removal
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2025
- Study start1 Jan 2026
- Primary completion1 Jan 2028 (estimated)
- Study completion1 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urinary Tract InfectionStudies of the same condition, open and under way.
- More trials run by Ohio State UniversityThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ohio State University
- Sponsor type
- University, hospital or other
- Collaborators
- Irrimax Corporation
- Responsible party
- Principal investigator, Hiren Patel, Ohio State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07239219
- Sponsor's protocol ID
- STUDY20250670
- Status last verified
- Nov 2025
- First submitted
- 14 Nov 2025
- Last updated
- 31 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- To Determine the Efficacy of Irrisept in Reducing Urinary Tract Infection During Urethral Catheter Removal.
- ClinicalTrials.gov ID
- NCT07239219
- Acronym / sponsor ID
- STUDY20250670
- Conditions
- Urinary Tract Infection, Antibiotic, Catheter Infection
- Keywords
- UTI, antibiotic, Catheter infection, CAUTI
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Ohio State UniversityUniversity, hospital or other
- Collaborators
- Irrimax Corporation
- Study start
- 1 Jan 2026 (actual)
- Primary completion
- 1 Jan 2028 (estimated)
- Study completion
- 1 Jan 2028 (estimated)
- First posted
- 20 Nov 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.
Given the high burden of post-catheter removal UTIs, this study aims to evaluate Irrisept instillation as a non-antibiotic intervention to reduce infection rates. By comparing Irrisept to saline irrigation, the study will provide critical insights into the efficacy of antiseptic bladder irrigation in preventing UTIs while minimizing antibiotic use. If successful, this approach could lead to new clinical guidelines for catheter removal protocols, improving patient outcomes and reducing healthcare costs.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | Active comparator | Other: Normal SalineStandard of care |
| Experimental | Experimental | Other: 0.05% Chlorhexidine GluconateExperimental |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Presenting to the urology clinic for catheter removal
- Must be 18 years or older.
- The patient must be able to understand and willing to provide informed consent as described in this study protocol.
- Must be willing to complete a post-catheter removal survey
Key exclusion criteria (7 listed)
- Allergy or adverse reaction to chlorohexidine gluconate
- Under the age of 18
- Refuse to provide informed consent
- On antibiotic therapy for any indication.
- Women who are pregnant or breastfeeding
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 |
|---|---|---|
| 0.05% Chlorhexidine Gluconate0.05% CHG is instilled into the bladder prior to trial of void. | Other | Experimental |
| Normal SalineBladder is back filled with normal saline. | Other | Control |
Primary outcome
Urinary tract infection
Time frame: 30 days
Evaluate the rate of urinary tract infection after urethral catheter removal.
2 secondary outcomes
Antibiotic use
Time frame: 30 days
Adverse Events
Time frame: 30 days
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 31 Jul 2026.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 0.05% Chlorhexidine Gluconate and Normal Saline in people with Urinary Tract Infection and Antibiotic, run by Ohio State University at 1 site 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 4 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 31 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Urinary tract infection (time frame: 30 days). 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 31 Jul 2026.