The Impact of Irrisept in Reducing Urinary Tract Infection During Urethral Catheter Removal.

November 16, 2025 updated by: Hiren Patel, Ohio State University

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

300

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Columbus, Ohio, United States, 43212-3153
        • Recruiting
        • The Ohio State University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental
Other: 0.05% Chlorhexidine Gluconate
0.05% CHG is instilled into the bladder prior to trial of void.
Active Comparator: Control
Standard of care
Other: Normal Saline
Bladder is back filled with normal saline.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Urinary tract infection
Time Frame: 30 days
Evaluate the rate of urinary tract infection after urethral catheter removal.
30 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Antibiotic use
Time Frame: 30 days
Evaluate the rates of antibiotic use 30 days after urethral catheter removal
30 days
Adverse Events
Time Frame: 30 days
Evaluate the rates of adverse events 30 days after urethral catheter removal
30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ohio State University

Collaborators

Irrimax Corporation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

December 31, 2025

Primary Completion (Estimated)

January 1, 2028

Study Completion (Estimated)

January 1, 2028

Study Registration Dates

First Submitted

November 14, 2025

First Submitted That Met QC Criteria

November 16, 2025

First Posted (Actual)

November 20, 2025

Study Record Updates

Last Update Posted (Actual)

November 20, 2025

Last Update Submitted That Met QC Criteria

November 16, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STUDY20250670

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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