Ignite Creation Date:
2024-05-06 @ 7:52 PM
Last Modification Date:
2024-10-26 @ 3:15 PM
Study NCT ID:
NCT06163469
Status:
RECRUITING
Last Update Posted:
2024-04-08
First Post:
2023-11-30
Brief Title:
Effect of Chlorhexidine Gluconate Bladder Instillations in Patients With Chronic Suprapubic Catheters on Unplanned Healthcare Encounters and Quality of Life
Sponsor:
Yale University
Organization:
Yale University
Study Overview
Official Title:
Instillation in Neurogenic Bladders to Decrease Unplanned Healthcare Encounters
Status:
RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this clinical trial is to evaluate the feasibility and tolerability of 005 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
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
Detailed Description:
Bacterial colonization is present in up to 95 of chronically catheterized patients Although a positive urine culture collected from an indwelling catheter is not in isolation indicative of an acute urinary tract infection UTI long term catheter use is associated with increased rates of recurrent urinary tract infections rUTI pyelonephritis and bacteremia Using antibiotics for prevention of infections in this patient population can be challenging given the side effects cost and emergence of resistant bacteria with antibiotic therapy To limit systemic side effects intravesical irrigation is a promising route of medication administration The use of a non-antibiotic anti-microbial at the time of SPC exchange would eliminate the obstacles of non-compliance and antibiotic resistance associated with antibiotic irrigation for preventive therapy Irrisept a 005 Chlorhexidine Gluconate CHG irrigation in sterile water could be a promising agent to reduce symptomatic UTIs and unplanned tube changes in chronically catheterized patients
The proposed route of intravesical instillation involves the administration of a therapeutic agent directly into the bladder via a urinary catheter This route allows for local contact with bladder mucosa and urinary pathogens It is a currently accepted route of administration used for therapeutics in urologic conditions including but not limited to UTI prophylaxis bladder cancer hemorrhagic cystitis and interstitial cystitis Benefits of intravesical instillation include maximizing exposure of the therapeutic within the bladder while limiting systemic absorption and side effects
A volume 150cc is based on current clinical administration of bladder instillations Current intravesical drug delivery is most commonly utilized in volumes 50-150cc for in-office instillation Population studies of normal volunteers demonstrate that 1st bladder sensation occurs between 125-200cc with subsequent desire to void occurring between 170-370cc Increasing instillation volumes greater than 150cc especially in the chronically catheterized population can lead to patient discomfort or dysreflexia and inability to tolerate the therapy without analgesia or anesthetic
The proposed route of intravesical instillation involves the administration of a therapeutic agent directly into the bladder via a urinary catheter This route allows for local contact with bladder mucosa and urinary pathogens It is a currently accepted route of administration used for therapeutics in urologic conditions including but not limited to UTI prophylaxis bladder cancer hemorrhagic cystitis and interstitial cystitis Benefits of intravesical instillation include maximizing exposure of the therapeutic within the bladder while limiting systemic absorption and side effects
A volume 150cc is based on current clinical administration of bladder instillations Current intravesical drug delivery is most commonly utilized in volumes 50-150cc for in-office instillation Population studies of normal volunteers demonstrate that 1st bladder sensation occurs between 125-200cc with subsequent desire to void occurring between 170-370cc Increasing instillation volumes greater than 150cc especially in the chronically catheterized population can lead to patient discomfort or dysreflexia and inability to tolerate the therapy without analgesia or anesthetic
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 000 | OTHER | CTGTY | None |