Chlorhexidine Irrigation for Bladder Cancer

Overseen By Sagar Shah, BS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Icahn School of Medicine at Mount Sinai

Disqualifiers: Pregnancy, Uncontrolled illness, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 5 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

40 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a special rinse called chlorhexidine, an antiseptic, to determine if it can prevent infections after certain bladder cancer surgeries. It specifically targets individuals undergoing a radical cystectomy (bladder removal) with a new urinary diversion method, such as an ileal conduit or neobladder. Researchers aim to discover if using this rinse during and after surgery keeps urine germ-free and reduces urinary tract infections within 30 days. This trial suits bladder cancer patients who require bladder surgery with urinary diversion and can use the rinse twice a day. As an unphased trial, it allows patients to contribute to innovative research that could enhance post-surgical outcomes.

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 prior data suggests that chlorhexidine irrigation is safe for bladder cancer patients undergoing radical cystectomy?

Research shows that chlorhexidine, used in this trial, is generally well-tolerated. It often serves as a disinfectant for cleaning skin and surgical areas. Past studies have demonstrated that rinsing wounds with chlorhexidine reduces infections after surgeries. Although specific safety data from this study is not yet available, chlorhexidine is widely used in healthcare for infection prevention. This widespread use suggests it is considered safe when used correctly, though it may have some side effects. Prospective participants should know that chlorhexidine has a strong history of safe use in similar medical situations. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Chlorhexidine is unique for bladder cancer treatment because it uses an antimicrobial approach to potentially reduce infection risks during surgery. Unlike standard chemotherapy or immunotherapy options, which target cancer cells, chlorhexidine focuses on preventing surgical site infections by cleansing the area with an antimicrobial wound lavage. This method is particularly exciting for researchers as it could improve surgical outcomes and patient recovery times by minimizing post-operative complications.

What evidence suggests that chlorhexidine irrigation might be an effective treatment for bladder cancer?

Research has shown that using chlorhexidine for bladder rinsing may reduce urinary tract infections in bladder cancer patients undergoing surgery. In this trial, patients having radical cystectomy with urinary diversion will receive Irrisept® Antimicrobial Wound Lavage as an intervention. One study found that using a product like Irrisept for bladder rinsing lowered infection rates after bladder removal surgery. Chlorhexidine effectively kills bacteria and keeps the urinary tract clean during recovery. Lower infection rates can lead to fewer complications and a smoother recovery. Overall, chlorhexidine rinsing appears promising for improving surgical outcomes in bladder cancer patients. ^{1 6 7 8 9}

Who Is on the Research Team?

John P Sfakianos, MD

Principal Investigator

Associate Professor of Urology

Are You a Good Fit for This Trial?

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.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• Chlorhexidine

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.

How Is the Trial Designed?

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 European Union, United States, Canada, Japan for the following indications:

Approved in European Union as Chlorhexidine for:

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

Approved in United States as Chlorhexidine for:

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

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+

Published Research Related to This Trial

In a study of 32 men undergoing prostate surgery, peri-operative irrigation with 0.05% chlorhexidine gluconate did not achieve sterile urine in most patients but significantly reduced the incidence of intra-operative bacteraemia and severe wound infections.

The use of chlorhexidine was safe, as it did not cause injuries to bladder mucosal tissue, and it also led to shorter post-operative urinary catheter requirements and hospital stays.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The use of intermittent chlorhexidine bladder irrigation in the prevention of post-prostatectomy infective complications. Adesanya, AA., Osegbe, DN., Amaku, EO.[2013]

In spinally injured patients undergoing intermittent catheterization, daily chlorhexidine antisepsis significantly reduced bacteriuria from 74% to 60% in male patients not on antibiotics (P < 0.01).

However, chlorhexidine did not affect perineal colonization by coliforms or environmental contamination, indicating that while it helps reduce urinary infections, it may not impact overall bacterial presence in the perineal area.

NCBI (Pubmed)

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. Sanderson, PJ., Weissler, S.[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]

Using a low-concentration hydrogen peroxide solution (0.15% HPS) for continuous bladder irrigation after transurethral resection of the prostate (TURP) significantly reduced postoperative blood loss compared to normal saline, with a smaller decrease in hemoglobin levels (3.38 g/L vs 7.29 g/L).

Patients receiving HPS experienced shorter bladder irrigation duration (32.57 hours vs 46.10 hours), lower catheter blockage rates (3.3% vs 11.8%), and reduced hospital stays (4.22 days vs 4.67 days), indicating that HPS is both effective and safe for postoperative care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Low-concentration hydrogen peroxide solution for continuous bladder irrigation after transurethral resection of the prostate]. Xu, M., Xue, BX., Yang, DR., et al.[2022]

In a study of 250 patients with low- to intermediate-risk non-muscle invasive bladder cancer, continuous saline bladder irrigation (CSBI) showed a 5-year recurrence-free survival rate of 62.6%, which is lower than the 70.4% rate for those receiving mitomycin C (MMC), but no significant differences in recurrence rates were found between the two treatments.

CSBI was associated with a significantly lower incidence of adverse events compared to MMC, suggesting it may be a safer option for patients after transurethral resection of bladder tumors.

NCBI (Pubmed)

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. Onishi, T., Sugino, Y., Shibahara, T., et al.[2017]

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 patients admitted for urological emergencies, regular chlorhexidine bladder irrigations significantly reduced the rate of catheter-induced urinary infections, keeping urine sterile in 52% of treated patients compared to only 26% in the control group.

This suggests that chlorhexidine bladder irrigations can be an effective preventive measure against urinary infections in patients with catheters, enhancing patient safety during hospital stays.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hibitane bladder irrigation in the prevention of catheter-associated urinary infection. Kirk, D., Dunn, M., Bullock, DW., et al.[2019]

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]

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 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]

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]

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC6261727/

Evaluation of an enhanced recovery protocol on patients ...

This study evaluates the safety and efficacy of the protocol for patients having radical cystectomy for bladder cancer. Methods. Length of stay (LOS), early in- ...

2.

cancer.gov

cancer.gov/research/participate/clinical-trials-search/v?id=NCI-2024-06347

Chlorhexidine Irrigation to Reduce Urinary Tract Infections ...

Bladder irrigation with using Irrisept may reduce the rate of urinary tract infections in patients with bladder cancer undergoing radical cystectomy with ...

3.

onlinelibrary.wiley.com

onlinelibrary.wiley.com/doi/10.1111/ijun.12392

The effect of preoperative oral hygiene on postoperative ...

This study showed a significant reduction in the prescription of antibiotics following cystectomy when participants completely adhered to ...

4.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC9280843/

Updates on enhanced recovery after surgery for radical ...

Collective data suggest ERAS contributes to improved complication rates, decreased hospital length-of-stay, and/or time to bowel recovery.

5.

researchgate.net

researchgate.net/profile/Justin-Collins-8/publication/303529060_Enhanced_Recovery_After_Robot-assisted_Radical_Cystectomy_EAU_Robotic_Urology_Section_Scientific_Working_Group_Consensus_View/links/5b607da50f7e9bc79a72a97c/Enhanced-Recovery-After-Robot-assisted-Radical-Cystectomy-EAU-Robotic-Urology-Section-Scientific-Working-Group-Consensus-View.pdf?origin=scientificContributions

Enhanced-Recovery-After-Robot-assisted-Radical- ...

An approach that combines robotic surgery with an ERP optimised for RARC patients has the potential to further improve patient outcomes. However, due to the.

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11807858/

Classification and Risk Factors for Surgical Site Infections ...

An estimated 83,000 patients will be diagnosed with bladder cancer in the United States alone, with an estimated 16,000 bladder cancer-related deaths in 2023.

7.

goldjournal.net

goldjournal.net/article/S0090-4295(23)00951-2/fulltext

Does Alexis Wound Protector/Retractor Reduce the Risk of ...

To assess if Alexis dual-ring wound protector/retractor reduced the incidence of superficial and deep incisional infection following open radical cystectomy ( ...

8.

sciencedirect.com

sciencedirect.com/science/article/pii/S0090429523009512

Does Alexis Wound Protector/Retractor Reduce the Risk of ...

The use of Alexis significantly reduces the rate of superficial and deep incisional infection following ORC.

9.

connect.careboxhealth.com

connect.careboxhealth.com/en-US/trial/listing/557217

Chlorhexidine Antiseptic Irrigation of the Bowel Segment ...

30 ± 7 days post radical cystectomy with urinary diversion. Outcome measure. Percentage of symptomatic urinary tract infections. Measure description.