Effect of Chlorhexidine Gluconate Bladder Instillations in Patients With Chronic Suprapubic Catheters on Unplanned Healthcare Encounters and Quality of Life

NCT ID: NCT06163469

Last Updated: 2025-05-13

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-04-01
• Study Completion Date: 2025-12-31

Brief Summary

The goal of this clinical trial is to evaluate the feasibility and tolerability of 0.05% Chlorhexidine Gluconate (CGH) bladder instillations in an outpatient setting at the time of suprapubic catheter (SPC) exchange in patients with history of recurrent urinary tract infections (UTI). The main questions are:

1. is instillation of 150mL of CGH for five-minute duration at the time of SPC exchange feasible in an outpatient setting and tolerable for patients.

2. does this protocol decrease the rate of unplanned health care visits and improve patient quality of life.

Patients will undergo the treatment protocol during their routine suprapubic catheter exchanges.

Detailed Description

Bacterial colonization is present in up to 95% of chronically catheterized patients. Although a positive urine culture collected from an indwelling catheter is not in isolation indicative of an acute urinary tract infection (UTI), long term catheter use is associated with increased rates of recurrent urinary tract infections (rUTI), pyelonephritis, and bacteremia. Using antibiotics for prevention of infections in this patient population can be challenging given the side effects, cost, and emergence of resistant bacteria with antibiotic therapy. To limit systemic side effects, intravesical irrigation is a promising route of medication administration. The use of a non-antibiotic anti-microbial at the time of SPC exchange would eliminate the obstacles of non-compliance and antibiotic resistance associated with antibiotic irrigation for preventive therapy. Irrisept, a 0.05% Chlorhexidine Gluconate (CHG) irrigation in sterile water, could be a promising agent to reduce symptomatic UTIs and unplanned tube changes in chronically catheterized patients.

The proposed route of intravesical instillation involves the administration of a therapeutic agent directly into the bladder via a urinary catheter. This route allows for local contact with bladder mucosa and urinary pathogens. It is a currently accepted route of administration used for therapeutics in urologic conditions including, but not limited to UTI prophylaxis, bladder cancer, hemorrhagic cystitis, and interstitial cystitis. Benefits of intravesical instillation include maximizing exposure of the therapeutic within the bladder while limiting systemic absorption and side effects.

A volume 150cc is based on current clinical administration of bladder instillations. Current intravesical drug delivery is most commonly utilized in volumes 50-150cc for in-office instillation. Population studies of normal volunteers demonstrate that 1st bladder sensation occurs between 125-200cc with subsequent desire to void occurring between 170-370cc. Increasing instillation volumes greater than 150cc, especially in the chronically catheterized population, can lead to patient discomfort or dysreflexia and inability to tolerate the therapy without analgesia or anesthetic.

Conditions

Neurogenic Bladder; Urinary Retention

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Arm I

Participants will get bladder instillations of normal saline for three months and then six months of instillations with chlorohexidine gluconate. After the instillation phase the patients will undergo an observational phase with six months of catheter exchanges without the intervention.

Group Type: EXPERIMENTAL

Bladder instillation with Irrisept

Intervention Type: DEVICE

9 months of bladder instillations (3 months of saline and 6 months of chlorohexidine gluconate)

Interventions

Bladder instillation with Irrisept

9 months of bladder instillations (3 months of saline and 6 months of chlorohexidine gluconate)

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Indwelling suprapubic catheter with insertion date at least 1 year prior to study enrollment date.
• History of urinary tract infections, treated for at least 1 positive urine culture in last 6 months

Exclusion Criteria

• Current radiographic evidence of urolithiasis
• History of vesicoureteral reflux
• History of renal transplantation
• History of bladder augmentation
• Inability to stop use of other rUTI prophylaxis treatments for the duration of their trial enrollment
• Life expectancy of less than 12 months prior to consent.
• Known hypersensitivity or allergy to chlorhexidine.
• Women who are pregnant or breastfeeding.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Irrimax Corporation

INDUSTRY

Sponsor Role: collaborator

Yale University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Joshua Sterling, MD, MSc

Role: PRINCIPAL_INVESTIGATOR

Yale University

Locations

Yale New Haven Health

New Haven, Connecticut, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Joshua Sterling, MD, MSc

Role: CONTACT

joshua.sterling@yale.edu

203-737-3619

Facility Contacts

Joshua Sterling

Role: primary

joshua.sterling@yale.edu

203-737-8076

Other Identifiers

000

Identifier Type: OTHER

Identifier Source: secondary_id

2000034836

Identifier Type: -

Identifier Source: org_study_id