Irrisept to reduce urinary tract infections when a urethral catheter is removed
To Determine the Efficacy of Irrisept in Reducing Urinary Tract Infection During Urethral Catheter Removal.
This study tests whether rinsing the bladder with Irrisept (0.05% chlorhexidine) instead of saline at the time of catheter removal reduces UTIs in adults having their urethral catheter removed.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 300 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Ohio State University Academic / other |
| Locations | 1 site (Columbus, Ohio) |
| Trial ID | NCT07239219 on ClinicalTrials.gov |
What this trial studies
Adults presenting to a urology clinic for urethral catheter removal will be assigned to receive bladder irrigation with either 0.05% chlorhexidine (Irrisept) or normal saline at the time of catheter removal. Participants will be followed with a post-removal survey and clinical monitoring for signs and laboratory-confirmed urinary tract infection over a defined follow-up period. Key exclusion criteria include current antibiotic therapy, active infection, pregnancy or breastfeeding, allergy to chlorhexidine, and catheter exchange procedures. The study compares infection rates and downstream antibiotic use between the two irrigation approaches to determine if the antiseptic irrigation reduces post-catheter UTIs.
Who should consider this trial
Good fit: Adults (age 18+) who present to the participating urology clinic for urethral catheter removal, can consent, are willing to complete a follow-up survey, and are not on antibiotics, pregnant, breastfeeding, or showing signs of current infection.
Not a fit: Patients already on antibiotic therapy, with active systemic or skin infection, who are pregnant or breastfeeding, undergoing catheter exchange, or allergic to chlorhexidine are unlikely to receive benefit or be eligible for this intervention.
Why it matters
Potential benefit: If successful, this approach could lower post-catheter UTI rates, reduce antibiotic use, and simplify catheter-removal protocols to improve patient outcomes and lower costs.
How similar studies have performed: Antiseptic bladder or catheter-care approaches have had mixed results in prior work, so this specific use of 0.05% chlorhexidine irrigation is relatively novel and has limited clinical precedent.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Presenting to the urology clinic for catheter removal 2. Must be 18 years or older. 3. The patient must be able to understand and willing to provide informed consent as described in this study protocol. 4. Must be willing to complete a post-catheter removal survey Exclusion Criteria: 1. Allergy or adverse reaction to chlorohexidine gluconate 2. Under the age of 18 3. Refuse to provide informed consent 4. On antibiotic therapy for any indication. 5. Women who are pregnant or breastfeeding 6. Signs of skin or systemic infection 7. Patients undergoing catheter exchange
Where this trial is running
Columbus, Ohio
- The Ohio State University — Columbus, Ohio, United States (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.