Clinical trial NCT06163469: Effect of Chlorhexidine Gluconate Bladder Instillations in Patients With Chronic Suprapubic Catheters on Unplanned Healthcare Encounters and Quality of Life
Official title: Instillation in Neurogenic Bladders to Decrease Unplanned Healthcare Encounters
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Neurogenic Bladder
Urinary Retention
Keywords: recurrent UTI
bladder irrigation
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: Irrimax Corporation
First posted: 2023-12-08
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: tolerability and feasibility of CGH bladder instillation
timeFrame: 9 months
Secondary outcomes:
measure: Incidence of bacteriuria
timeFrame: monthly for 15 months
measure: effect of chlorhexidine gluconate catheter biofilm flora
timeFrame: up to 9 months
measure: Incidence of symptomatic UTI
timeFrame: up to 15 months
measure: impact of mechanical bladder washing
timeFrame: up to 9 months
measure: effect of chlorhexidine changes the microbiome of the bladder
timeFrame: up to 15 months
measure: unplanned healthcare contact between routine SPC exchanges
timeFrame: up to 15 months
measure: patient quality of life and overall satisfaction
timeFrame: up to 15 months
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale New Haven Health
state: Connecticut
Study officials:
affiliation: Yale University
name: Joshua Sterling, MD, MSc
role: PRINCIPAL_INVESTIGATOR
References: