RECRUITINGINTERVENTIONAL

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

Instillation in Neurogenic Bladders to Decrease Unplanned Healthcare Encounters

About This Trial

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 May Be Eligible (Plain English)

Who May Qualify: - 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 Who Should NOT Join This Trial: - 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. Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language

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.

Treatments Being Tested

DEVICE

Bladder instillation with Irrisept

9 months of bladder instillations (3 months of saline and 6 months of chlorohexidine gluconate)

Locations (1)

Yale New Haven Health

New Haven, Connecticut, United States