40 Participants Needed

Chlorhexidine Irrigation for Bladder Cancer

MF
SS
Overseen BySagar Shah, BS
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Icahn School of Medicine at Mount Sinai
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 5 JurisdictionsThis treatment is already approved in other countries

Trial Summary

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.12345

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.16789

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.39101112

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.

Research Team

JP

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
See 3 more

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.
See 1 more

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
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
1Treatment groups
Experimental Treatment
Group I: Patients undergoing radical cystectomy with urinary diversionExperimental Treatment1 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

Find a Clinic Near You

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

References

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]
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]
The use of intermittent chlorhexidine bladder irrigation in the prevention of post-prostatectomy infective complications. [2013]
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]
[Intravesical BCG, mitomycin-C and thiotepa in the prevention of bladder tumor recurrence after operation]. [2013]
Anaphylactic reaction to intraurethral chlorhexidine: sensitisation following previous repeated uneventful administration. [2021]
A comparison of the effect of chlorhexidine antisepsis, soap and antibiotics on bacteriuria, perineal colonization and environmental contamination in spinally injured patients. [2019]
[Low-concentration hydrogen peroxide solution for continuous bladder irrigation after transurethral resection of the prostate]. [2022]
Bladder irrigation with chlorhexidine for the prevention of urinary infection after transurethral operations: a prospective controlled study. [2019]
Hibitane bladder irrigation in the prevention of catheter-associated urinary infection. [2019]
11.United Statespubmed.ncbi.nlm.nih.gov
Water versus antiseptic periurethral cleansing before catheterization among home care patients: a randomized controlled trial. [2013]
The effect of chlorhexidine irrigation of the bladder in the rat. [2019]
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