Using Chlorhexidine Gluconate to improve outcomes for patients with chronic suprapubic catheters
Instillation in Neurogenic Bladders to Decrease Unplanned Healthcare Encounters
This study is testing if a special solution called Chlorhexidine can help people with chronic suprapubic catheters avoid urinary infections and improve their quality of life during catheter changes.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 70 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Yale University Academic / other |
| Locations | 1 site (New Haven, Connecticut) |
| Trial ID | NCT06163469 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are patients with an indwelling suprapubic catheter for at least one year and a history of urinary tract infections.
Not a fit: Patients with current urolithiasis, renal transplantation, or known hypersensitivity to chlorhexidine may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly reduce the incidence of recurrent UTIs and improve the quality of life for patients with chronic suprapubic catheters.
How similar studies have performed: While the use of intravesical irrigation for UTI prophylaxis is established, the specific application of Chlorhexidine Gluconate in this context is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
New Haven, Connecticut
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.