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

NCT06163469 | Recruiting FDA Device

• 2 other identifiers: 2000034836000
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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. 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. 2.does this protocol decrease the rate of unplanned health care visits and improve patient quality of life.

Conditions

Neurogenic Bladder; Urinary Retention

Keywords

recurrent UTI; bladder irrigation

Outcome Measures

Primary Outcomes (1)

• tolerability and feasibility of CGH bladder instillation

  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.

  9 months

Secondary Outcomes (7)

• Incidence of bacteriuria

  monthly for 15 months

• effect of chlorhexidine gluconate catheter biofilm flora

  up to 9 months

• Incidence of symptomatic UTI

  up to 15 months

• impact of mechanical bladder washing

  up to 9 months

• effect of chlorhexidine changes the microbiome of the bladder

  up to 15 months

Study Arms (1)

Arm I

EXPERIMENTAL

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.

Device: Bladder instillation with Irrisept

Interventions

Bladder instillation with Irrisept DEVICE

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

Arm I

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Yale University: lead
• Irrimax Corporation: collaborator

Study Sites (1)

Yale New Haven Health

New Haven, Connecticut, 06519, United States

RECRUITING

MeSH Terms

Conditions

Urinary Bladder, Neurogenic; Urinary Retention; Urinary Tract Infections

Interventions

Administration, Intravesical

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Nervous System Diseases; Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Urination Disorders; Infections

Intervention Hierarchy (Ancestors)

Administration, Topical; Drug Administration Routes; Drug Therapy; Therapeutics

Study Officials

• Joshua Sterling, MD, MSc

  Yale University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Joshua Sterling, MD, MSc

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 30, 2023
• First Posted: December 8, 2023
• Study Start: April 1, 2024
• Primary Completion: June 30, 2025
• Study Completion: December 31, 2025
• Last Updated: May 13, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE
• Time Frame: beginning 3 months and ending 5 years following article publication
• Access Criteria: Researchers who provide a methodologically sound proposal.

Locations

US (1)