RecruitingNot ApplicableNCT06163469

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


Sponsor

Yale University

Enrollment

70 participants

Start Date

Apr 1, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

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

Min Age: 18 Years

Inclusion Criteria2

  • 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 Criteria8

  • 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.

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Interventions

DEVICEBladder 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

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NCT06163469


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