Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID06163469

Effect of Chlorhexidine Gluconate Bladder Instillations During Suprapubic Catheter Exchange on Unplanned Healthcare Visits and Quality of Life in Patients with Neurogenic Bladder

Led by Yale University · Updated on 2025-05-13

70

Participants Needed

1

Research Sites

26 weeks

Total Duration

On this page

Sponsors

Y

Yale University

Lead Sponsor

I

Irrimax Corporation

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are evaluating the use of 0.05% Chlorhexidine Gluconate (CHG) bladder instillations to reduce unplanned healthcare visits and improve quality of life in patients with neurogenic bladder and chronic suprapubic catheters who have a history of recurrent urinary tract infections. This trial explores whether applying CHG directly into the bladder during routine catheter exchanges is feasible and tolerable in an outpatient setting. The study addresses challenges with antibiotic resistance and side effects by testing a non-antibiotic antimicrobial approach. Participants will receive bladder instillations through their suprapubic catheters as part of their usual catheter exchange visits. The treatment includes three months of normal saline instillations followed by six months of 0.05% Chlorhexidine Gluconate instillations. After the nine-month instillation period, there will be an additional six months of observation with catheter exchanges without any instillations. This protocol is designed to maximize bladder exposure to the therapeutic agent while minimizing systemic absorption and side effects. During the study, participants will undergo monthly assessments for bacteriuria, symptomatic urinary tract infections, and changes in bladder microbiome and catheter biofilm flora. Researchers will also monitor the tolerability and feasibility of the instillations, the impact on unplanned healthcare visits, and patient quality of life and satisfaction. The total study duration is 15 months, during which patients will participate in treatment and observation phases with regular follow-up evaluations.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Indwelling suprapubic catheter inserted at least one year before enrollment
  • History of urinary tract infections with at least one positive urine culture treated in the last six months
Not Eligible

You will not qualify if you...

  • Current radiographic evidence of urolithiasis
  • History of vesicoureteral reflux
  • History of renal transplantation
  • History of bladder augmentation
  • Unable to stop other recurrent UTI prevention treatments during the trial
  • Life expectancy less than 12 months before consent
  • Known allergy or hypersensitivity to chlorhexidine
  • Women who are pregnant or breastfeeding

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - 9 months

Participants receive bladder instillations starting with 3 months of saline followed by 6 months of chlorhexidine gluconate instillations to reduce urinary tract infections and unplanned catheter changes.

Visits at each suprapubic catheter exchange during the 9 months of instillations

Follow-up

Duration - 6 months

Participants are observed for 6 months after treatment during routine suprapubic catheter exchanges without bladder instillations to monitor outcomes.

Visits at routine catheter exchanges during the 6-month observational phase

Trial Site Locations

Total: 1 location

1

Yale New Haven Health

New Haven, Connecticut, United States, 06519

Actively Recruiting

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Research Team

J

Joshua Sterling, MD, MSc

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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