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

Part of paid clinical trials in New Haven, Connecticut.

Sponsor
Yale University
Study ID
NCT06163469
Status
Recruiting
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Conditions

  • Neurogenic Bladder
  • Urinary Retention

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Bladder instillation with Irrisept — DEVICE
    9 months of bladder instillations (3 months of saline and 6 months of chlorohexidine gluconate)

Study Details

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.

Key Dates

Start date
Apr 1, 2024
Status verified
May 2025
Primary completion
Jun 30, 2025
Completion
Dec 31, 2025

Study Design

Enrollment
70 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

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.

Primary Outcome Measure

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

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Yale New Haven HealthNew HavenConnecticut06519
Joshua Sterling
[email protected]
203-737-8076

Find similar trials in New Haven, CT

By research site
Yale New Haven Health· New Haven, CT

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