A Novel Urinary Access System for Universal Transcatheter Cystoscopy at The Time of Hysterectomy
Status unconfirmed · Not applicable
Conditions studied: Hysterectomy
In brief
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.
Key facts
- Study ID
- NCT03503175
- Run by
- Atlantic Health System
- People needed
- 364
- Starts
- 2018-07-26
- Expected to finish
- 2022-03-01
- Last updated by the study team
- 2020-07-28
Who can join
Age: 18 and older, up to 90. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- Women age 18-90
- Undergoing hysterectomy with or without concomitant procedures
You may not qualify if…
- 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
Where it is running
- Atlantic Urogynecology Associates — Morristown, New Jersey, United States (enrolling)
Full record on ClinicalTrials.gov
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