Neurogenic BladderNCT06163469
Effect of Chlorhexidine Gluconate Bladder Instillations in Patients With Chronic Suprapubic Catheters on Unplanned Healthcare Encounters and Quality of Life
A study testing Bladder instillation with Irrisept in people with Neurogenic Bladder and Urinary Retention, run by Yale University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neurogenic Bladder, Urinary Retention
- What is being tested?
- Bladder instillation with Irrisept
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2024to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Yale New Haven Health
New Haven, Connecticut, 06519
Joshua Sterling, 203-737-8076, joshua.sterling@yale.edu
About this study
Official title: Instillation in Neurogenic Bladders to Decrease Unplanned Healthcare Encounters
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:
- 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.
- 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.
Read the 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 0.05% 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.
- Conditions
- Neurogenic Bladder, Urinary Retention
- Being tested
- Bladder instillation with Irrisept
- Keywords
- recurrent UTI, bladder irrigation
- Medical subject headings
- Urinary Bladder, Neurogenic, Urinary Retention, Urinary Tract Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bladder instillation with IrriseptDevice
9 months of bladder instillations (3 months of saline and 6 months of chlorohexidine gluconate)
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Bladder instillation with Irrisept |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 9 months
Secondary outcomes (7)
Incidence of bacteriuria
Urine cultures will be taken at each SPC exchange for nine months while undergoing irrigations (3 months with saline and 6 months with Irrisept) and for an additional six months following completion of instillation treatment. Incidence of bacteriuria prior to the start of instillation will be compared to the incidence during the instillation phase and observation phase.
Measured: monthly for 15 months
effect of chlorhexidine gluconate catheter biofilm flora
the catheter tips will be sent for culture at each exchange. results between the saline and CGH irrigations will be compared
Measured: up to 9 months
Incidence of symptomatic UTI
Participants will complete a validated UTI symptom assessment at the time of instillation and then three days later when the urine culture is finalized. Responses will be compared to each participants self reported typical UTI symptoms to differentiate between asymptomatic bacteruria and symptomatic UTI.
Measured: up to 15 months
impact of mechanical bladder washing
Urine culture results and patient questionnaires during the saline irrigations will be compared to those during the CGH irrigation
Measured: up to 9 months
effect of chlorhexidine changes the microbiome of the bladder
Urine culture data from the CGH instillation phase will be compared to culture data from the saline irrigation and observational period. Changes in the dominant bacteria from each culture will be reported.
Measured: up to 15 months
unplanned healthcare contact between routine SPC exchanges
At each SPC change and instillation an interval history will be taken any unplanned healthcare utilization (I.e. emergency room, primary care, and urology calls and visits) will be recorded. The number of recorded events during the instillation and observation phases will be compared.
Measured: up to 15 months
patient quality of life and overall satisfaction
participants will complete a validated six question quality of life questionnaire at months 0, 3, 6, 9, 12, and 15. Changes in the sum total (lower the sum the higher the quality of life) and individual responses will be tabulated.
Measured: up to 15 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2023
- Study start1 Apr 2024
- Primary completion30 Mar 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neurogenic BladderStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- Irrimax Corporation
- Responsible party
- Sponsor
- Investigators
- Joshua Sterling, MD, MSc, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06163469
- Sponsor's protocol ID
- 2000034836
- Other IDs
- 000
- Status last verified
- Jun 2026
- First submitted
- 30 Nov 2023
- Last updated
- 18 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Instillation in Neurogenic Bladders to Decrease Unplanned Healthcare Encounters
- ClinicalTrials.gov ID
- NCT06163469
- Acronym / sponsor ID
- 2000034836
- Conditions
- Neurogenic Bladder, Urinary Retention
- Keywords
- recurrent UTI, bladder irrigation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- Irrimax Corporation
- Study start
- 1 Apr 2024 (actual)
- Primary completion
- 30 Mar 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 8 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
- 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 0.05% 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arm I | Experimental | Device: Bladder instillation with IrriseptParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bladder instillation with Irrisept9 months of bladder instillations (3 months of saline and 6 months of chlorohexidine gluconate) | Device | Arm I |
Primary outcome
tolerability and feasibility of CGH bladder instillation
Time frame: 9 months
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.
7 secondary outcomes
Incidence of bacteriuria
Time frame: monthly for 15 months
effect of chlorhexidine gluconate catheter biofilm flora
Time frame: up to 9 months
Incidence of symptomatic UTI
Time frame: up to 15 months
impact of mechanical bladder washing
Time frame: up to 9 months
effect of chlorhexidine changes the microbiome of the bladder
Time frame: up to 15 months
unplanned healthcare contact between routine SPC exchanges
Time frame: up to 15 months
patient quality of life and overall satisfaction
Time frame: up to 15 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2026.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Joshua Sterling, MD, MSc principal investigator
Yale University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bladder instillation with Irrisept in people with Neurogenic Bladder and Urinary Retention, run by Yale University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Joshua Sterling, MD, MSc (203-737-3619, joshua.sterling@yale.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
tolerability and feasibility of CGH bladder instillation (time frame: 9 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2026.