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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorYale University

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

70 Participants
are divided into 1 treatment group

Sponsors and collaborators

Yale University

Lead sponsor

Irrimax Corporation

Collaborator