Status:
RECRUITING
Effect of Chlorhexidine Gluconate Bladder Instillations in Patients With Chronic Suprapubic Catheters on Unplanned Healthcare Encounters and Quality of Life
Lead Sponsor:
Yale University
Collaborating Sponsors:
Irrimax Corporation
Conditions:
Neurogenic Bladder
Urinary Retention
Eligibility:
All Genders
18+ years
Phase:
NA
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...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2025
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT06163469
Start Date
April 1 2024
End Date
December 31 2025
Last Update
May 13 2025
Active Locations (1)
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1
Yale New Haven Health
New Haven, Connecticut, United States, 06519