A Novel Urinary Access System for Universal Transcatheter Cystoscopy at The Time of Hysterectomy

Atlantic Health System

Status: Unknown

Conditions: Hysterectomy

Treatments: Device: Standard Foley catheter; Device: Novel urinary access system (CystoSureTM)

Study type: Interventional

Funder types: Other

Identifiers

NCT03503175

1178748

Details and patient eligibility

About

Cystoscopy is a commonly performed procedure after gynecologic surgery, however, its use may increase patients' risk for acquiring urinary tract infections due to urinary tract instrumentation entry and reentry of the lower urinary tract with the cystoscope and foley catheter. Use of a novel multi-channel transurethral bladder catheter that allows for cystoscopy through a specialized port will permit cystoscopy to be performed without catheter removal. This may allow for intraoperative detection of urinary tract injuries with a reduction in both urethral manipulation and hospital-associated urinary tract infections. Other potential benefits may include a shorter procedure time and ease of use for providers.

Full description

A cystoscopy is a procedure that inserts a thin tube with a light and camera through the urethra, so that the inside of the bladder can be checked for injuries. Current guidelines recommend that this is done after a hysterectomy. Normally, doing a cystoscopy requires that a patient's foley catheter (a tube inserted through the urethra and into the bladder to drain urine) gets removed and then replaced. This can potentially lead to a urinary tract infection (UTI).

CystoSureTM is a silicone device that was developed by surgeons to enable easy and standardized cystoscopy. The design of the CystoSureTM catheter has separate channels for draining the bladder and performing cystoscopy, so doctors can perform a cystoscopy without removing the catheter (which can, as described above, potentially lead to a UTI). In this study, investigators want to examine whether using a CystoSureTM catheter instead of a standard foley catheter could therefore lead to a reduced number of UTIs in hysterectomy patients. CystoSureTM is cleared by the FDA.

Enrollment: 364 estimated patients

Sex: Female

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Women age 18-90
• Undergoing hysterectomy with or without concomitant procedures

Exclusion criteria

• Known history of urinary tract anomaly (i.e. urethral diverticulum, ureteral duplication, ectopic ureter)
• ≥3 UTIs in past 6 months
• Immunosuppressed patients
• Premeditated urologic procedure during hysterectomy surgery

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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364 participants in 2 patient groups

Novel urinary access system

Experimental group

Description:

Participants randomized to this arm will receive the novel urinary access system (CystoSureTM).

Treatment:

Device: Novel urinary access system (CystoSureTM)

Standard Foley catheter

Active Comparator group

Description:

Participants randomized to this arm will receive a standard Foley catheter and rigid cystoscopy.

Treatment:

Device: Standard Foley catheter