Clinical trial NCT03503175: A Novel Urinary Access System for Universal Transcatheter Cystoscopy at The Time of Hysterectomy
Official title: A Novel Urinary Access System for Universal Transcatheter Cystoscopy at The Time of Hysterectomy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hysterectomy
Lead sponsor: Atlantic Health System
Sponsor class: OTHER
First posted: 2018-04-19
Enrollment: 364
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: Urinary tract infections
timeFrame: Up to 4 weeks after surgery
Secondary outcomes:
measure: Detection of urinary tract injuries
timeFrame: At the time of surgery
measure: Device feasibility
timeFrame: At the time of surgery
measure: Surgeon satisfaction
timeFrame: After the first and last patient enrolled by each surgeon, through study completion (which is estimated to be up to 24 months after enrollment begins).
Other outcomes:
Locations:
city: Morristown
country: United States
facility: Atlantic Urogynecology Associates
state: New Jersey
Study officials:
References: