Study of Chlorhexidine Gluconate for Chronic Suprapubic Catheters

This study is looking at whether using 0.05% Chlorhexidine Gluconate (CGH) bladder instillations can help patients with long-term suprapubic catheters (a tube placed into the bladder through the belly) who often get urinary tract infections (UTIs). The main goals are to see if these instillations are easy to do in an outpatient setting and if patients can tolerate them well. Researchers also want to find out if this treatment can reduce unplanned hospital visits and improve your quality of life. You might be able to join if you are 18 or older, have had a suprapubic catheter for at least a year, and have had UTIs in the past six months. The study is currently recruiting 70 participants.

Study design
This is an interventional study, meaning participants will receive a specific treatment. It plans to enroll 70 participants.
What's involved
You would receive bladder instillations during your routine suprapubic catheter exchanges for 9 months (3 months of saline followed by 6 months of chlorhexidine gluconate).
Compensation
Not stated in the trial record.
Follow-up
The primary endpoints for tolerability and feasibility are measured at 9 months.

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NCT06163469

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

Recruiting
NAAges 18+InterventionalTreatment
Yale University
~70 participants
Updated 2026-06-18 on ClinicalTrials.gov
What's tested:Bladder instillation with Irrisept

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
tolerability and feasibility of CGH bladder instillation
Measured over 9 months
Neurogenic Bladder
Urinary Retention
1 sites across 1 states
Connecticut1
  • Joshua Sterling, MD, MSc · PRINCIPAL_INVESTIGATOR · Yale University

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Eligibility criteria

Inclusion

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

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.
  • tolerability and feasibility of CGH bladder instillation9 months

    Tolerability and feasibility of CGH bladder instillation of 150mL for five-minute duration at the time of SPC exchange. Volumes of each instillation and tolerated dwell time will be recorded with each instillation.