Recruiting

Irrisept & Saline

Sponsor:

Ohio State University

Code:

NCT07239219

Conditions

Urinary Tract Infection

Antibiotic

Catheter Infection

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

0.05% Chlorhexidine Gluconate

Normal Saline

Study Details

Brief 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 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

Study ID

NCT07239219

Start date

Jan 1, 2026

Status verified date

Nov, 2025

Completion date

Jan 1, 2028

Anticipated

Primary completion date

Jan 1, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

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 Design

Enrollment

300 participants

Anticipated

Allocation

Randomized

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Control

Standard of care

experimental: Experimental

Experimental

Interventions

0.05% Chlorhexidine Gluconate

0.05% CHG is instilled into the bladder prior to trial of void.

Normal Saline

Bladder is back filled with normal saline.

Primary outcome measure

  • Urinary tract infection [ Time Frame: 30 days ]

Central Contacts and Locations

Locations

The Ohio State University

Recruiting

Columbus, Ohio, United States, 43212-3153

Contacts

Hiren Patel, MD, PhD

6142938155hiren.patel@osumc.edu

More Information

Sponsor

Ohio State University

Last update posted

Jul 31, 2026

Last verified

Nov, 2025

Keywords

  • UTI
  • antibiotic
  • Catheter infection
  • CAUTI

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Ohio State University on 2026-07-31.