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Procedure

Chlorhexidine Gluconate for Neurogenic Bladder

N/A

Recruiting

Led By Joshua Sterling, MD, MSc

Research Sponsored by Yale University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Must not have

History of vesicoureteral reflux

History of renal transplantation

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 15 months

Awards & highlights

No Placebo-Only Group

Summary

This trial tests a therapy to reduce UTIs and improve quality of life in patients with recurrent UTIs. It looks at how feasible and tolerable it is in an outpatient setting.

Who is the study for?

This trial is for people who've had a suprapubic catheter for over a year and have had urinary tract infections treated in the last 6 months. It's not for those with certain bladder conditions, kidney issues, or allergies to chlorhexidine. Pregnant or breastfeeding women and patients on other UTI prevention treatments can't join.

What is being tested?

The study tests if rinsing the bladder with Chlorhexidine Gluconate during routine catheter changes is doable in an outpatient setting, tolerable by patients, reduces unplanned healthcare visits, and improves quality of life.

What are the potential side effects?

Possible side effects may include discomfort at the instillation site or allergic reactions to Chlorhexidine Gluconate for those sensitive to it.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had a condition where urine flows backward from my bladder to kidneys.

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I have had a kidney transplant.

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I have had surgery to make my bladder larger.

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I am not pregnant or breastfeeding.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 15 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 15 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 15 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

tolerability and feasibility of CGH bladder instillation

Secondary study objectives

Incidence of bacteriuria

Incidence of symptomatic UTI

effect of chlorhexidine changes the microbiome of the bladder

+4 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Arm IExperimental Treatment1 Intervention

Participants will get bladder instillations of normal saline for three months and then six months of instillations with chlorohexidine gluconate. After the instillation phase the patients will undergo an observational phase with six months of catheter exchanges without the intervention.

0 / 4Eligibility criteria met