NCT07239219

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for not_applicable

Timeline
20mo left

Started Dec 2025

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress17%
Dec 2025Jan 2028

First Submitted

Initial submission to the registry

November 14, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 20, 2025

Completed
1 month until next milestone

Study Start

First participant enrolled

December 31, 2025

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2028

Last Updated

November 20, 2025

Status Verified

November 1, 2025

Enrollment Period

2 years

First QC Date

November 14, 2025

Last Update Submit

November 16, 2025

Conditions

Urinary Tract InfectionAntibioticCatheter Infection

Keywords

UTIantibioticCatheter infectionCAUTI

Outcome Measures

Primary Outcomes (1)

  • Urinary tract infection

    Evaluate the rate of urinary tract infection after urethral catheter removal.

    30 days

Secondary Outcomes (2)

  • Antibiotic use

    30 days

  • Adverse Events

    30 days

Study Arms (2)

Control

ACTIVE COMPARATOR

Standard of care

Other: Normal Saline

Experimental

EXPERIMENTAL

Experimental

Other: 0.05% Chlorhexidine Gluconate

Interventions

0.05% Chlorhexidine GluconateOTHER

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

Experimental
Normal SalineOTHER

Bladder is back filled with normal saline.

Control

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Ohio State University

Columbus, Ohio, 43212-3153, United States

RECRUITING

MeSH Terms

Conditions

Urinary Tract Infections

Interventions

chlorhexidine gluconateSaline Solution

Condition Hierarchy (Ancestors)

InfectionsUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

Crystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical Preparations

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor, Principal Investigator

Study Record Dates

First Submitted

November 14, 2025

First Posted

November 20, 2025

Study Start

December 31, 2025

Primary Completion (Estimated)

January 1, 2028

Study Completion (Estimated)

January 1, 2028

Last Updated

November 20, 2025

Record last verified: 2025-11

Locations

US(1)