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.
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
Current radiographic evidence of urolithiasis
History of vesicoureteral reflux
History of renal transplantation
History of bladder augmentation
Single group
Bladder instillation with Irrisept
Device9 months of bladder instillations (3 months of saline and 6 months of chlorohexidine gluconate)
tolerability and feasibility of CGH bladder instillation
Tolerability and feasibility of CGH bladder instillation of 150mL for five-minute duration at the time of SPC exchange. Volumes of each instillation and tolerated dwell time will be recorded with each instillation.
Incidence of bacteriuria
Urine cultures will be taken at each SPC exchange for nine months while undergoing irrigations (3 months with saline and 6 months with Irrisept) and for an additional six months following completion of instillation treatment. Incidence of bacteriuria prior to the start of instillation will be compared to the incidence during the instillation phase and observation phase.
effect of chlorhexidine gluconate catheter biofilm flora
the catheter tips will be sent for culture at each exchange. results between the saline and CGH irrigations will be compared
Incidence of symptomatic UTI
Participants will complete a validated UTI symptom assessment at the time of instillation and then three days later when the urine culture is finalized. Responses will be compared to each participants self reported typical UTI symptoms to differentiate between asymptomatic bacteruria and symptomatic UTI.
impact of mechanical bladder washing
Urine culture results and patient questionnaires during the saline irrigations will be compared to those during the CGH irrigation
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Yale University
Lead sponsor
Irrimax Corporation
Collaborator
