Effect of Chlorhexidine Gluconate Bladder Instillations in Patients With Chronic Suprapubic Catheters on Unplanned Healthcare Encounters and Quality of Life

Launched by YALE UNIVERSITY · Nov 30, 2023

Keywords

ClinConnect Summary

This clinical trial is looking at a treatment method using a solution called Chlorhexidine Gluconate (CGH) for patients with chronic suprapubic catheters, which are tubes placed in the bladder to help with urine drainage. The purpose of the study is to see if using this solution during routine catheter exchanges can make it easier for patients and help reduce the number of unexpected trips to the doctor due to urinary tract infections (UTIs). Additionally, researchers want to find out if this treatment improves the overall quality of life for participants.

To join the study, participants need to have had a suprapubic catheter for at least one year and a history of UTIs, with at least one positive urine test in the last six months. However, individuals with certain conditions like kidney stones, specific bladder issues, or allergies to chlorhexidine cannot participate. During the trial, participants will receive the treatment when they have their catheters changed in an outpatient setting. This means they can go home the same day without needing to stay overnight in the hospital.

Gender

ALL

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.