Chlorhexidine Gluconate for Neurogenic Bladder

Recruiting in Palo Alto (17 mi)

Overseen by Joshua Sterling, MD, MSc

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Yale University

Disqualifiers: Urolithiasis, Vesicoureteral reflux, Renal transplant, others

No Placebo Group

Approved in 3 Jurisdictions

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

If you are currently using other treatments to prevent recurrent urinary tract infections, you will need to stop them while participating in this trial.

Is Chlorhexidine Gluconate safe for use in the bladder?

Chlorhexidine Gluconate can cause severe bladder irritation and allergic reactions in some people, even if they have used it before without problems. It is not recommended for prolonged use in the bladder due to the risk of severe irritation. ^{1 2 3 4 5}

How does the treatment with Chlorhexidine Gluconate for Neurogenic Bladder differ from other treatments?

Chlorhexidine Gluconate is unique because it is used as a bladder instillation, meaning it is directly introduced into the bladder, which is different from many other treatments that might be taken orally or applied externally. However, studies have shown that prolonged contact with the bladder can cause severe irritation, and there is a risk of allergic reactions, making its use potentially problematic compared to other treatments. ^{1 5 6 7 8}

Research Team

Joshua Sterling, MD, MSc

Principal Investigator

Yale University

Eligibility Criteria

This trial is for people who've had a suprapubic catheter for over a year and have had urinary tract infections treated in the last 6 months. It's not for those with certain bladder conditions, kidney issues, or allergies to chlorhexidine. Pregnant or breastfeeding women and patients on other UTI prevention treatments can't join.

Inclusion Criteria

Indwelling suprapubic catheter with insertion date at least 1 year prior to study enrollment date.

I have been treated for a urinary tract infection in the last 6 months.

Exclusion Criteria

I have had a condition where urine flows backward from my bladder to kidneys.

Current radiographic evidence of urolithiasis

I have had a kidney transplant.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment - Saline Instillation

Participants receive bladder instillations of normal saline for three months during routine SPC exchanges

3 months

Monthly visits for SPC exchange and instillation

Treatment - Chlorhexidine Gluconate Instillation

Participants receive bladder instillations with chlorhexidine gluconate for six months during routine SPC exchanges

6 months

Monthly visits for SPC exchange and instillation

Observation

Participants undergo an observational phase with six months of catheter exchanges without the intervention

6 months

Monthly visits for SPC exchange

Follow-up

Participants are monitored for safety and effectiveness after treatment

3 months

Treatment Details

Interventions

• Bladder instillation with Irrisept (Procedure)

Trial Overview The study tests if rinsing the bladder with Chlorhexidine Gluconate during routine catheter changes is doable in an outpatient setting, tolerable by patients, reduces unplanned healthcare visits, and improves quality of life.

Participant Groups

Group I: Arm I Experimental Treatment 1 Intervention

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.

Bladder instillation with Irrisept is already approved in United States, European Union, Australia for the following indications:

🇺🇸 Approved in United States as Irrisept for:

• Prevention of urinary tract infections in patients with chronic suprapubic catheters

🇪🇺 Approved in European Union as Chlorhexidine Gluconate for:

• Antiseptic for skin and wound cleansing
• Preparation for catheterization

🇦🇺 Approved in Australia as Chlorhexidine Gluconate for:

• Antiseptic for skin and wound cleansing
• Preparation for catheterization

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Yale New Haven Health New Haven, CT

Who Is Running the Clinical Trial?

Yale University

Lead Sponsor

Trials

1963

Patients Recruited

3,046,000+

Irrimax Corporation

Industry Sponsor

Trials

11

Patients Recruited

2,100+

References

1. England pubmed.ncbi.nlm.nih.gov

The effect of chlorhexidine irrigation of the bladder in the rat. [2019] Rats' bladders were irrigated with aqueous solutions of chlorhexidine digluconate 1 : 5,000 or 1 : 10,000 for varying periods up to 48 hours. Histologic examination of the bladders showed severe erosive cystitis in a high percentage of cases. It is concluded that chlorhexidine cannot be recommended for prolonged irrigation of the bladder or for instillation during the intermittent catheterisation where chlorhexidine has repeated and prolonged contact with bladder mucosa.

2. England pubmed.ncbi.nlm.nih.gov

Prospective, randomized, double-blind study of safety and tolerability of intravesical resiniferatoxin (RTX) in interstitial cystitis (IC). [2018] To determine the safety and tolerability of intravesical resiniferatoxin (RTX) in interstitial cystitis (IC) patients.

3. Iran pubmed.ncbi.nlm.nih.gov

The efficacy and safety of intravesical Bacillus-Calmette-Guerin in the treatment of female patients with interstitial cystitis: a double-blinded prospective placebo controlled study. [2007] To evaluate the efficacy and safety of intravesical Bacillus Calmette-Gurein injection in the treatment of female patients with interstitial cystitis.

4. England pubmed.ncbi.nlm.nih.gov

Prospective, randomized trial to evaluate high-versus low-dose interferon-alpha 2b versus conventional chemotherapy in prevention of the recurrence of superficial transitional cell carcinoma of the urinary bladder. [2019] Forty-four patients with superficial bladder cancer were randomized to receive 10 MU (14 patients) or 100 MU (14 patients) of interferon (IFN)-alpha 2b or 1.3 g ethoglucid (16 patients) instilled into the bladder once weekly for 10 weeks and then monthly for 1 year. Efficacy (evaluated in 34 patients who completed the course of treatment), based on recurrence rate and time to first recurrence, was similar in the three groups. No systemic toxicity of treatment was seen. Severe chemocystitis occurred in some patients who received ethoglucid (three had to discontinue treatment), while no local toxicity was seen with IFN-alpha 2b treatment.

5. England pubmed.ncbi.nlm.nih.gov

Anaphylactic reaction to intraurethral chlorhexidine: sensitisation following previous repeated uneventful administration. [2021] Instillagel(®) (CliniMed, High Wycombe, UK) is commonly used in urethral catheterisation and to facilitate the passage of instruments into the bladder in urological practice. Its active ingredients include 0.25% chlorhexidine, 2% lidocaine, 0.06% methyl hydroxybenzoate and 0.025% propyl hydroxybenzoate. We discuss the case of an 84-year-old man who received intraurethral Instillagel(®) prior to laser ablation of a recurrent transitional cell carcinoma of the bladder, resulting in anaphylaxis. Subsequent investigation confirmed allergy to chlorhexidine. Although there are previous reports in the literature, this is the first report of intraurethral chlorhexidine resulting in anaphylaxis in a patient who had had repeated, uneventful previous exposures. As such, this case illustrates the phenomenon of chlorhexidine sensitisation and that previous uneventful exposures do not exclude the diagnosis of anaphylaxis in the context of sudden, unexpected deterioration.

6. United States pubmed.ncbi.nlm.nih.gov

Development and characterization of an infection inhibiting urinary catheter. [2014] Catheter associated bacturia is common in hospitals and nursing homes. The objective of this study was to develop an infection inhibiting urinary catheter for prolonged use. Methods were established to add chlorhexidine digluconate (CHG) to a silicone elastomer and to compression mold the material to form a urinary catheter. CHG was randomly dispersed in the elastomer to be released through elution. Samples of the material, with CHG concentrations ranging from 1 to 4% by weight, were tested for in vitro release characteristics over a 28 day period and for in vivo toxicity over a 7 day period. Release profiles followed a common pattern for each concentration: an initial peak during the first 24 hours was followed by a subsequent decline. CHG amounts released into the saline medium were directly related to the CHG concentration of the samples; 4% samples released the largest amounts and 1% samples released the least amounts. Both 3% and 4% CHG by weight samples released measurable amounts of CHG throughout the entire observation period, whereas 1% CHG by weight samples were depleted after 9 days, and 2% CHG by weight samples were depleted after 19 days. No samples were found to be toxic during in vivo evaluations. These studies suggest that CHG bearing silicone rubber urinary catheters could resist surface colonization and infection for extended periods without toxicity.

7. United States pubmed.ncbi.nlm.nih.gov

Myelin toxicity of chlorhexidine in zebrafish larvae. [2023] Chlorhexidine gluconate (CHG) is a topical antiseptic solution recommended for skin preparation before central venous catheter placement and maintenance in adults and children. Although CHG is not recommended for use in children aged

8. United States pubmed.ncbi.nlm.nih.gov

Chlorhexidine in urethral gel: does it cause pain at flexible cystoscopy? [2013] To investigate the effect of chlorhexidine gluconate in urethral local anesthetic gel on patients undergoing outpatient flexible cystoscopy. We postulated that chlorhexidine was contributing to the pain and urgency that occurs during and after cystoscopy.