A Novel Urinary Access System for Universal Transcatheter Cystoscopy at The Time of Hysterectomy
| Status: | Recruiting |
|---|---|
| Healthy: | No |
| Age Range: | 18 - 90 |
| Updated: | 8/23/2018 |
| Start Date: | July 26, 2018 |
| End Date: | May 1, 2020 |
| Contact: | Caroline Sabatino, MPH, CCRP |
| Email: | caroline.sabatino@atlantichealth.org |
| Phone: | 973-971-7361 |
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.
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.
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.
Inclusion Criteria:
- Women age 18-90
- Undergoing hysterectomy with or without concomitant procedures
Exclusion Criteria:
- Active UTI or treated for UTI in prior 2 weeks
- 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
We found this trial at
1
site
Morristown, New Jersey 07960
Principal Investigator: Charbel G Salamon, MD, MS
Phone: 973-971-7361
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