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NCT Number: NCT07239219

The Impact 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.

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Key information

Conditions

Urinary Tract Infection Antibiotic Catheter Infection Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Infections Male Urogenital Diseases Urinary Tract Infections Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Ohio State University

Columbus, Ohio, 43212-3153, United States

Location status: Recruiting

Location contact

Hiren Patel, MD, PhD

CONTACT

[email protected]

6142938155

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

0.05% Chlorhexidine Gluconate

Other

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

Normal Saline

Other

Bladder is back filled with normal saline.

Primary outcomes

  1. Urinary tract infection

    Time frame: 30 days

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

Secondary outcomes

  1. Antibiotic use

    Time frame: 30 days

    Evaluate the rates of antibiotic use 30 days after urethral catheter removal

  2. Adverse Events

    Time frame: 30 days

    Evaluate the rates of adverse events 30 days after urethral catheter removal

Sponsors and collaborators

Lead sponsor

Ohio State University

Other

Collaborators

  • Irrimax Corporation

Registry information

Official study title

To Determine the Efficacy of Irrisept in Reducing Urinary Tract Infection During Urethral Catheter Removal.

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Nov 20, 2025
Registry last updated
Nov 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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