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

Description

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.

Conditions

Neurogenic Bladder, Urinary Retention

Study Overview

Study Details

Study overview

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.

Instillation in Neurogenic Bladders to Decrease Unplanned Healthcare Encounters

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

Condition
Neurogenic Bladder
Intervention / Treatment

-

Contacts and Locations

New Haven

Yale New Haven Health, New Haven, Connecticut, United States, 06519

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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.

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Yale University,

Joshua Sterling, MD, MSc, PRINCIPAL_INVESTIGATOR, Yale School of Medicine

Study Record Dates

2025-12-31