Actively Recruiting
Effect of Chlorhexidine Gluconate Bladder Instillations in Patients With Chronic Suprapubic Catheters on Unplanned Healthcare Encounters and Quality of Life
Led by Yale University · Updated on 2025-05-13
70
Participants Needed
1
Research Sites
91 weeks
Total Duration
On this page
Sponsors
Y
Yale University
Lead Sponsor
I
Irrimax Corporation
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official 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 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
You will not qualify if you...
- 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.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here