Instillation in Neurogenic Bladders to Decrease Unplanned Healthcare Encounters

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
United States
Connecticut
Yale New Haven Health
RECRUITING
New Haven
Contact Information
Primary
Joshua Sterling, MD, MSc
joshua.sterling@yale.edu
203-737-3619
Time Frame
Start Date: 2024-04-01
Estimated Completion Date: 2025-12-31
Participants
Target number of participants: 70
Treatments
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.
Sponsors
Collaborators: Irrimax Corporation
Leads: Yale University

This content was sourced from clinicaltrials.gov