NCT06163469 Effect of Chlorhexidine Gluconate Bladder Instillations in Patients With Chronic Suprapubic Catheters on Unplanned Healthcare Encounters and Quality of Life
| NCT ID | NCT06163469 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Yale University |
| Condition | Neurogenic Bladder |
| Study Type | INTERVENTIONAL |
| Enrollment | 70 participants |
| Start Date | 2024-04-01 |
| Primary Completion | 2025-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 70 participants in total. It began in 2024-04-01 with a primary completion date of 2025-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 (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.
Eligibility 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.
Contact & Investigator
Joshua Sterling, MD, MSc
PRINCIPAL INVESTIGATOR
Yale University
Frequently Asked Questions
Who can join the NCT06163469 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Neurogenic Bladder. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06163469 currently recruiting?
Yes, NCT06163469 is actively recruiting participants. Contact the research team at joshua.sterling@yale.edu for enrollment information.
Where is the NCT06163469 trial being conducted?
This trial is being conducted at New Haven, United States.
Who is sponsoring the NCT06163469 clinical trial?
NCT06163469 is sponsored by Yale University. The principal investigator is Joshua Sterling, MD, MSc at Yale University. The trial plans to enroll 70 participants.