Using Chlorhexidine Gluconate to improve outcomes for patients with chronic suprapubic catheters

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial evaluates the feasibility and tolerability of administering 0.05% Chlorhexidine Gluconate (CGH) bladder instillations during outpatient suprapubic catheter exchanges in patients with a history of recurrent urinary tract infections (UTIs). The study aims to determine if this treatment can reduce unplanned healthcare visits and enhance the quality of life for these patients. Participants will receive a 150mL instillation of CGH for five minutes at the time of catheter exchange, allowing for direct contact with the bladder mucosa. The approach seeks to minimize systemic side effects and antibiotic resistance associated with traditional antibiotic prophylaxis.

Why it matters

Who can join: the full rules

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.

Where it's running

• Yale New Haven Health
  New Haven, Connecticut, United States Recruiting

Study contacts

• Principal investigator: Joshua Sterling, MD, MSc — Yale University
• Study coordinator: Joshua Sterling, MD, MSc
• Email: joshua.sterling@yale.edu
• Phone: 203-737-3619

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.