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

NCT ID: NCT07239219

Last Updated: 2025-11-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-12-31

Study Completion Date

2028-01-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Urinary Tract Infection Antibiotic Catheter Infection

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Control

Standard of care

Group Type ACTIVE_COMPARATOR

Normal Saline

Intervention Type OTHER

Bladder is back filled with normal saline.

Experimental

Experimental

Group Type EXPERIMENTAL

0.05% Chlorhexidine Gluconate

Intervention Type OTHER

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

0.05% Chlorhexidine Gluconate

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

Intervention Type OTHER

Normal Saline

Bladder is back filled with normal saline.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Irrimax Corporation

INDUSTRY

Sponsor Role collaborator

Ohio State University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Hiren Patel

Assistant Professor, Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

The Ohio State University

Columbus, Ohio, United States

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

United States

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Hiren Patel, MD, PhD

Role: primary

6142938155

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

STUDY20250670

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Intravesical LGG VS Saline Bladder Wash RCT
NCT05230511 RECRUITING PHASE2