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

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

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07239219

Enrollment

300

Registered

2025-11-20

Start date

2026-01-01

Completion date

2028-01-01

Last updated

2026-07-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Antibiotic, Catheter Infection, Urinary Tract Infection

Keywords

UTI, antibiotic, Catheter infection, CAUTI

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.

Interventions

OTHER0.05% Chlorhexidine Gluconate

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

OTHERNormal Saline

Bladder is back filled with normal saline.

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

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

Design outcomes

Primary

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

Secondary

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 1, 2026