Hysterectomy Clinical Trial
Official title:
A Novel Urinary Access System for Universal Transcatheter Cystoscopy at The Time of Hysterectomy
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.
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.
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