RecruitingNot Applicable

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

United States70 participantsStarted 2024-04-01

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion 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 Exclusion Criteria: * 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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Since this trial is studying whether chlorhexidine gluconate bladder instillations are tolerable and feasible — rather than already proving they work — what do we actually know so far about whether this approach is safe for people using suprapubic catheters long-term?
2I have a chronic suprapubic catheter due to neurogenic bladder or urinary retention — how would my specific situation affect whether I might be a good candidate to even discuss this study with the research team?
3The trial is measuring unplanned healthcare encounters and quality of life as outcomes — how does that compare to what standard care is currently doing for me in terms of reducing infections or hospital visits?
4What does the bladder instillation process actually involve day-to-day, and is the time commitment or procedure something that would realistically fit into my current routine?
5Before considering a study like this, are there established treatments for managing my catheter-related complications that my care team thinks I should try first?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

tolerability and feasibility of CGH bladder instillation

Timeframe: 9 months

Trial details

NCT IDNCT06163469

SponsorYale University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-03-30

Contact for this trial

Joshua Sterling, MD, MSc

203-737-3619 joshua.sterling@yale.edu

View on ClinicalTrials.gov More Neurogenic Bladder trials