Bladder Cancer, Urinary Tract Infection
Conditions
Keywords
Bladder Cancer, Radical Cystectomy, Ileal Conduit, Neobladder, Chlorhexidine Gluconate, Irrisept
Brief summary
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.
Detailed description
Th research team proposes to increase the rate of sterilization of urine from patients with urinary diversion and reduce the incidence of UTI up to 30 ± 7 days post radical cystectomy and urinary diversion using 50 ± 25ml of Irrisept ® irrigation solution lavage of the bowel segment during surgery for a contact time of 2 minutes. For patients who obtain an ileal conduits irrigation using 50 ± 25ml of Irrisept ® will be performed daily for 10 days +/- 3 days and for those patients obtaining ileal neobladders irrigation using 50 ± 25ml of Irrisept ® will continue for 21 days +/- 7 days. The irrigation will continue for the given time described above as this is usually when stents and catheters are removed.
Interventions
DEVICEIrrisept® Antimicrobial Wound Lavage
Irrisept® Antimicrobial Wound Lavage is a single-use, manual, self-contained irrigation device comprised of a 450mL bottle of 0.05% Chlorhexidine Gluconate (CHG) in 99.95% Sterile Water for Irrigation, United States Pharmacopeia (USP) and an applicator (labeled Irriprobe®). The solution is aseptically filled in a Blow-Fill-Seal (BFS) bottle. The CHG acts as a preservative to inhibit microbial growth in the solution.
Sponsors
Irrimax Corporation
Icahn School of Medicine at Mount Sinai
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
This is single center, open-label study where the participants will be identified from the principal investigator and sub-investigator's clinic. All the participants who meet the study criteria and sign the consent form will be assigned to the study intervention.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Provision of signed and dated informed consent form. * Stated availability for the duration of the study, and willingness to comply with all study procedures, including willingness to adhere to twice daily irrigation of neobladder or ileal conduit. * Male or female, ≥ 18 years of age * Confirmed diagnosis of bladder cancer * Candidate for radical cystectomy with urinary diversion * ECOG performance status of 0-2 * Serum creatinine ≤ 1.5 mg/dL
Exclusion criteria
* Has undergone or planned to undergo urinary diversion other than ileal conduit or neobladder. * Pregnancy or lactation. * Known allergic reactions to components of the Irrisept irrigating system, chlorhexidine. * Patient must not have any uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that, in the opinion of the investigator, would limit compliance with study requirements.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants that have negative urine culture | 30 ± 7 days post radical cystectomy with urinary diversion. | Negative urine culture will be defined as a colony count of less than or equal to 100000 CFU/ml. The urine sample will be collected by catheterization of the conduit with a 16F Foley catheter, which provides the least number of CFU of bacteria compared to collection from the ostomy bag. Patients with ileal neobladder will give a spontaneously voided urine sample when able or will be obtained from catheterized urine for those who cannot void. |
| Proportion of participants with incident symptomatic UTI | 30 ± 7 days post radical cystectomy with urinary diversion. | Proportion of participants with incident symptomatic UTI by 30 ± 7 days post radical cystectomy with urinary diversion. Symptomatic UTI will be defined as a positive urine culture in the presence of fever (≥38°C) with or without associated flank/abdominal pain. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of urine leak from neobladder/ ileal conduit | 30 ± 7 days post radical cystectomy with urinary diversion | — |
| Percentage of patients with sepsis | 30 ± 7 days post radical cystectomy with urinary diversion | Percentage of patients with sepsis (when the body reacts to an infection) will be assessed. In case \>/= 10% of participants experience sepsis, the intervention will be considered unacceptable. |
| Percentage of symptomatic urinary tract infections | 30 ± 7 days post radical cystectomy with urinary diversion | Symptomatic urinary tract infection is when a person has positive UTI and has fever and other symptoms including pain when passing urine and pain in the lower belly. |
Countries
United States
Contacts
Primary ContactMonali Fatterpekar, PhD
Backup ContactSagar Shah, BS
Outcome results
None listed