NCT07239219 · Ohio State University
The Impact of Irrisept in Reducing Urinary Tract Infection During Urethral Catheter Removal.
What this study is about
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 effectiveness of antiseptic bladder irrigation in preventing UTIs while minimizing antibiotic use.
View original scientific description
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.
Interventions
OTHER
0.05% Chlorhexidine Gluconate
0.05% CHG is instilled into the bladder prior to trial of void.
OTHER
Normal Saline
Bladder is back filled with normal saline.
Primary outcome measures
Urinary tract infection
Time frame: 30 days
Evaluate the rate of urinary tract infection after urethral catheter removal.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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
Exclusion criteria
- 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
Where
- Columbus, Ohio
Collaborators
Irrimax Corporation
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Nov 20, 2025 · Source of record for eligibility and locations