Effect of Chlorhexidine Gluconate Bladder Instillations in Patients With Chronic Suprapubic Catheters on Unplanned Healthcare Encounters and Quality of Life (NCT06163469)
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: To join this study, participants generally need to meet the listed inclusion criteria (2 items) and avoid the listed exclusions (9 items).
Location: Yale New Haven Health — New Haven, Connecticut
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistCheck every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).
Usually NOT eligible if any of the following apply:
- 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.
🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
📍 All Participating Trial Locations (1 Sites)
- Yale New Haven Health — New Haven, Connecticut
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.