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Procedure

Arm I for Urinary Retention

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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 15 months
Awards & highlights

Study 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.Check my eligibility
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.See study design
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.

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
tolerability and feasibility of CGH bladder instillation
Secondary outcome measures
Incidence of bacteriuria
Incidence of symptomatic UTI
effect of chlorhexidine changes the microbiome of the bladder
+4 more

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.

Find a Location

Who is running the clinical trial?

Yale UniversityLead Sponsor
1,853 Previous Clinical Trials
2,738,491 Total Patients Enrolled
Irrimax CorporationIndustry Sponsor
9 Previous Clinical Trials
2,007 Total Patients Enrolled
Joshua Sterling, MD, MScPrincipal InvestigatorYale School of Medicine

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is there an ongoing call for participants in this trial?

"Per the information found on clinicaltrials.gov, this research endeavour is not currently accepting participants. Originally posted on January 1st 2024 and last updated on November 30th 2023, it appears that there are 65 other trials actively recruiting patients now."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Effect of Chlorhexidine Gluconate Bladder Instillations in Patients With Chronic Suprapubic Catheters on Unplanned Healthcare Encounters and Quality of Life
2024. "Effect of Chlorhexidine Gluconate Bladder Instillations in Patients With Chronic Suprapubic Catheters on Unplanned Healthcare Encounters and Quality of Life". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06163469.
All > Urinary Retention
~47 spots leftby Jun 2025
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