NCT03503175

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 364 (estimated)
• Sponsor: Atlantic Health System · Academic / Other
• Sex: Female
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed 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.

Conditions

• Hysterectomy

Interventions

Type	Name	Description
DEVICE	Novel urinary access system (CystoSureTM)	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).
DEVICE	Standard Foley catheter	Participants randomized to this arm will receive a standard Foley catheter and standard rigid cystoscopy.

Timeline

• Start date: 2018-07-26
• Primary completion: 2022-02-01
• Completion: 2022-03-01
• First posted: 2018-04-19
• Last updated: 2020-07-28

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study