Recruiting

Chlorhexidine Gluconate

Sponsor:

Yale University

Code:

NCT06163469

Conditions

Neurogenic Bladder

Urinary Retention

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Bladder instillation with Irrisept

Study Details

Brief 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.

Conditions

Neurogenic Bladder

Urinary Retention

Study ID

NCT06163469

Start date

Apr 1, 2024

Status verified date

Jun, 2026

Completion date

Dec 31, 2027

Anticipated

Primary completion date

Mar 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

70 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Arm I

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.

Interventions

Bladder instillation with Irrisept

9 months of bladder instillations (3 months of saline and 6 months of chlorohexidine gluconate)

Primary outcome measure

  • tolerability and feasibility of CGH bladder instillation [ Time Frame: 9 months ]

Central Contacts and Locations

Central contacts

Joshua Sterling, MD, MSc

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

Locations

Yale New Haven Health

Recruiting

New Haven, Connecticut, United States, 06519

Contacts

Joshua Sterling

203-737-8076joshua.sterling@yale.edu

More Information

Sponsor

Yale University

Last update posted

Jun 18, 2026

Last verified

Jun, 2026

Keywords

  • recurrent UTI
  • bladder irrigation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Yale University on 2026-06-18.