Chlorhexidine Irrigation for Bladder Cancer

Overseen By Sagar Shah, BS

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Icahn School of Medicine at Mount Sinai

Disqualifiers: Pregnancy, Uncontrolled illness, others

No Placebo Group

Approved in 5 Jurisdictions

Trial Summary

What is the purpose of this trial?

This is a single arm, interventional pilot study of using chlorhexidine irrigation intra-operatively and post-operatively among patients undergoing radical cystectomy with urinary diversion. The intervention comprises of using irrigation of ileal conduit or ileal neobladder intra-operatively and then for irrigation of either post-surgery with Irrisept ®. The sterilization of urine will be assessed at 10 days after cystectomy. Incidence of symptomatic urinary tract infections within the 30-day post-operative period will be estimated.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.

What data supports the effectiveness of the treatment Chlorhexidine for bladder cancer?

Research on chlorhexidine irrigation in other contexts, like after prostate surgery, shows it can help reduce infections, but there's no direct evidence for its effectiveness in treating bladder cancer. ^{1 2 3 4 5}

Is chlorhexidine safe for use in bladder irrigation?

Chlorhexidine has been used safely for bladder irrigation in some studies, with no evidence of bladder damage or toxic side effects, although small amounts were found in the blood of some patients. However, there is a risk of allergic reactions, such as anaphylaxis (a severe allergic reaction), even in those who have used it without problems before. ^{1 6 7 8 9}

How is the treatment chlorhexidine unique for bladder cancer?

Chlorhexidine is unique for bladder cancer as it is primarily an antiseptic used to prevent infections, and its use in bladder cancer is novel compared to standard cancer treatments like chemotherapy or immunotherapy. It is administered through bladder irrigation, which is different from typical systemic cancer treatments. ^{3 9 10 11 12}

Research Team

John P Sfakianos, MD

Principal Investigator

Associate Professor of Urology

Eligibility Criteria

This trial is for patients undergoing radical cystectomy with urinary diversion due to bladder cancer. Participants must be suitable for surgery and willing to have their surgical site irrigated with a chlorhexidine solution both during and after the procedure.

Inclusion Criteria

Provision of signed and dated informed consent form

I have been diagnosed with bladder cancer.

Serum creatinine ≤ 1.5 mg/dL

Exclusion Criteria

Pregnancy or lactation

Known allergic reactions to components of the Irrisept irrigating system, chlorhexidine

I have had or will have surgery to redirect urine flow not using ileal conduit or neobladder.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Surgery and Initial Treatment

Participants undergo radical cystectomy with urinary diversion and receive intra-operative chlorhexidine irrigation

1 day

1 visit (in-person)

Post-operative Irrigation

Participants receive daily irrigation with Irrisept for 10 to 21 days depending on the type of urinary diversion

10-21 days

Follow-up

Participants are monitored for sterilization of urine and incidence of symptomatic urinary tract infections

30 days

Treatment Details

Interventions

• Chlorhexidine (Antiseptic)

Trial Overview The study tests the effectiveness of Irrisept® (a chlorhexidine-based antimicrobial wound lavage) in sterilizing urine and reducing urinary tract infections when used during and after bladder surgery.

Participant Groups

Group I: Patients undergoing radical cystectomy with urinary diversion Experimental Treatment 1 Intervention

Patients undergoing radical cystectomy and ileal conduit or ileal neobladder will receive Irrisept ® Antimicrobial Wound Lavage as intervention

Chlorhexidine is already approved in Canada, Japan for the following indications:

Approved in Canada as Chlorhexidine for:

• Preoperative skin preparation
• Hand hygiene
• Mouthwash
• Dental plaque control
• Gingivitis treatment
• Skin infections
• Wound care

Approved in Japan as Chlorhexidine for:

• Preoperative skin preparation
• Hand hygiene
• Mouthwash
• Dental plaque control
• Gingivitis treatment
• Skin infections
• Wound care

Who Is Running the Clinical Trial?

Icahn School of Medicine at Mount Sinai

Lead Sponsor

Trials

933

Recruited

579,000+

Irrimax Corporation

Industry Sponsor

Trials

11

Recruited

2,100+

Findings from Research

In a study of 167 patients with low- to intermediate-risk Non-Muscle Invasive Bladder Cancer (NMIBC), Continuous Saline Bladder Irrigation (CSBI) significantly reduced the risk of bladder tumor recurrence after blue light transurethral resection (TURBT), with recurrence rates of 23.1% in the CSBI group compared to 45.8% in the control group.

CSBI was found to be safe, with no reported complications related to the irrigation, suggesting it could be a beneficial addition to post-surgical care for NMIBC patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Continuous saline bladder irrigation after blue light transurethral resection of bladder tumor increases recurrence-free survival in low- to intermediate-risk non-muscle invasive bladder cancer. Gondran-Tellier, B., Abdallah, R., Sichez, PC., et al.[2021]

In a study of 235 patients with non-muscle invasive bladder cancer, overnight continuous saline bladder irrigation (CSBI) after thulium laser en bloc resection and immediate chemotherapy did not significantly improve recurrence-free survival (RFS) or progression-free survival (PFS) compared to those who did not receive CSBI.

Both groups experienced only Grade I complications, indicating that overnight CSBI is safe but does not enhance oncological outcomes for patients undergoing this treatment regimen.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Overnight Continuous Saline Bladder Irrigation After En Bloc Resection of Bladder Tumor Does Not Improve Oncological Outcomes in Patients Who Have Received Intravesical Chemotherapy. Yang, Y., Liu, C., Yan, X., et al.[2022]

Intravesical irrigation with BCG significantly reduced the recurrence rate of bladder tumors to 12.5%, compared to 46.9% for Mitomycin-C and 61.8% for Thiotepa, indicating BCG's superior efficacy in preventing tumor recurrence after surgery.

Despite BCG's effectiveness, the study suggests that due to its side effects, Mitomycin-C or Thiotepa may be preferred as first-line treatments for preventing recurrence, especially in patients who cannot tolerate BCG.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Intravesical BCG, mitomycin-C and thiotepa in the prevention of bladder tumor recurrence after operation]. Wang, SH.[2013]

An 84-year-old man experienced anaphylaxis after receiving Instillagel(®) for urethral catheterization, highlighting a serious allergic reaction to chlorhexidine, one of its active ingredients.

This case emphasizes that even patients with prior uneventful exposures to chlorhexidine can develop sensitization, leading to unexpected anaphylactic reactions during subsequent uses.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Anaphylactic reaction to intraurethral chlorhexidine: sensitisation following previous repeated uneventful administration. Dyer, JE., Nafie, S., Mellon, JK., et al.[2021]

In a randomized controlled study of men after transurethral operations, postoperative bladder irrigation with chlorhexidine significantly reduced the incidence of bacteriuria from 36.7% in control patients to 12.8% in those receiving the antiseptic, indicating its efficacy in preventing urinary infections.

Chlorhexidine irrigation did not eliminate pre-existing infections, but it was found to be safe, with no evidence of bladder damage or toxic side effects, despite small amounts being detected in the blood of some patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bladder irrigation with chlorhexidine for the prevention of urinary infection after transurethral operations: a prospective controlled study. Ball, AJ., Carr, TW., Gillespie, WA., et al.[2019]

A randomized controlled trial involving 20 home care patients found no significant difference in urinary tract infection risk between using 0.05% chlorhexidine gluconate (CHG) and sterile water for periurethral cleansing before catheterization.

None of the participants developed symptomatic bacteriuria, indicating that using sterile water is a safe alternative for cleansing without increasing infection risk.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Water versus antiseptic periurethral cleansing before catheterization among home care patients: a randomized controlled trial. Cheung, K., Leung, P., Wong, YC., et al.[2013]

Irrigation of rat bladders with chlorhexidine digluconate solutions (1:5,000 and 1:10,000) for up to 48 hours resulted in severe erosive cystitis in many cases, indicating significant tissue damage.

The study concludes that chlorhexidine should not be used for prolonged bladder irrigation or during intermittent catheterization due to its harmful effects on the bladder mucosa.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of chlorhexidine irrigation of the bladder in the rat. Harper, WE., Matz, LR.[2019]

References

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

Randomized controlled study of the efficacy and safety of continuous saline bladder irrigation after transurethral resection for the treatment of non-muscle-invasive bladder cancer. [2017]

2. France pubmed.ncbi.nlm.nih.gov

Continuous saline bladder irrigation after blue light transurethral resection of bladder tumor increases recurrence-free survival in low- to intermediate-risk non-muscle invasive bladder cancer. [2021]

3. Netherlands pubmed.ncbi.nlm.nih.gov

The use of intermittent chlorhexidine bladder irrigation in the prevention of post-prostatectomy infective complications. [2013]

4. Switzerland pubmed.ncbi.nlm.nih.gov

Overnight Continuous Saline Bladder Irrigation After En Bloc Resection of Bladder Tumor Does Not Improve Oncological Outcomes in Patients Who Have Received Intravesical Chemotherapy. [2022]

5. China pubmed.ncbi.nlm.nih.gov

[Intravesical BCG, mitomycin-C and thiotepa in the prevention of bladder tumor recurrence after operation]. [2013]

6. England pubmed.ncbi.nlm.nih.gov

Anaphylactic reaction to intraurethral chlorhexidine: sensitisation following previous repeated uneventful administration. [2021]

7. England pubmed.ncbi.nlm.nih.gov

A comparison of the effect of chlorhexidine antisepsis, soap and antibiotics on bacteriuria, perineal colonization and environmental contamination in spinally injured patients. [2019]

8. China pubmed.ncbi.nlm.nih.gov

[Low-concentration hydrogen peroxide solution for continuous bladder irrigation after transurethral resection of the prostate]. [2022]

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

Bladder irrigation with chlorhexidine for the prevention of urinary infection after transurethral operations: a prospective controlled study. [2019]

10. England pubmed.ncbi.nlm.nih.gov

Hibitane bladder irrigation in the prevention of catheter-associated urinary infection. [2019]

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

Water versus antiseptic periurethral cleansing before catheterization among home care patients: a randomized controlled trial. [2013]

12. England pubmed.ncbi.nlm.nih.gov

The effect of chlorhexidine irrigation of the bladder in the rat. [2019]