Actively Recruiting
Effect of Chlorhexidine Gluconate Bladder Instillations During Suprapubic Catheter Exchange on Unplanned Healthcare Visits and Quality of Life in Patients with Neurogenic Bladder
Led by Yale University · Updated on 2025-05-13
70
Participants Needed
1
Research Sites
26 weeks
Total Duration
On this page
Sponsors
Y
Yale University
Lead Sponsor
I
Irrimax Corporation
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the use of 0.05% Chlorhexidine Gluconate (CHG) bladder instillations to reduce unplanned healthcare visits and improve quality of life in patients with neurogenic bladder and chronic suprapubic catheters who have a history of recurrent urinary tract infections. This trial explores whether applying CHG directly into the bladder during routine catheter exchanges is feasible and tolerable in an outpatient setting. The study addresses challenges with antibiotic resistance and side effects by testing a non-antibiotic antimicrobial approach. Participants will receive bladder instillations through their suprapubic catheters as part of their usual catheter exchange visits. The treatment includes three months of normal saline instillations followed by six months of 0.05% Chlorhexidine Gluconate instillations. After the nine-month instillation period, there will be an additional six months of observation with catheter exchanges without any instillations. This protocol is designed to maximize bladder exposure to the therapeutic agent while minimizing systemic absorption and side effects. During the study, participants will undergo monthly assessments for bacteriuria, symptomatic urinary tract infections, and changes in bladder microbiome and catheter biofilm flora. Researchers will also monitor the tolerability and feasibility of the instillations, the impact on unplanned healthcare visits, and patient quality of life and satisfaction. The total study duration is 15 months, during which patients will participate in treatment and observation phases with regular follow-up evaluations.
CONDITIONS
Brief Title
Effect of Chlorhexidine Gluconate Bladder Instillations in Patients With Chronic Suprapubic Catheters on Unplanned Healthcare Encounters and Quality of Life
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Indwelling suprapubic catheter inserted at least one year before enrollment
- History of urinary tract infections with at least one positive urine culture treated in the last six months
You will not qualify if you...
- Current radiographic evidence of urolithiasis
- History of vesicoureteral reflux
- History of renal transplantation
- History of bladder augmentation
- Unable to stop other recurrent UTI prevention treatments during the trial
- Life expectancy less than 12 months before consent
- Known allergy or hypersensitivity to chlorhexidine
- Women who are pregnant or breastfeeding
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 9 months
Participants receive bladder instillations starting with 3 months of saline followed by 6 months of chlorhexidine gluconate instillations to reduce urinary tract infections and unplanned catheter changes.
Visits at each suprapubic catheter exchange during the 9 months of instillations
Duration - 6 months
Participants are observed for 6 months after treatment during routine suprapubic catheter exchanges without bladder instillations to monitor outcomes.
Visits at routine catheter exchanges during the 6-month observational phase
Trial Site Locations
Total: 1 location
1
Yale New Haven Health
New Haven, Connecticut, United States, 06519
Actively Recruiting
Research Team
J
Joshua Sterling, MD, MSc
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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