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.
Eligibility criteria
Qualifiers
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
Disqualifiers
Current radiographic evidence of urolithiasis
History of vesicoureteral reflux
History of renal transplantation
History of bladder augmentation
Trial design
Treatments tested in this trial
- Bladder instillation with Irrisept
Treatment groups
Sponsors and collaborators
Yale University
Lead sponsor
Irrimax Corporation
Collaborator