Hysterectomy
Conditions
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.
Interventions
DEVICEStandard Foley catheter
Participants randomized to this arm will receive a standard Foley catheter and standard rigid cystoscopy.
DEVICENovel 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).
Sponsors
Atlantic Health System
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 90 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Urinary tract infections | Up to 4 weeks after surgery | Rate of urinary tract infections (within 4 weeks of surgery) in patients undergoing cystoscopy with the novel urinary access system (CystoSureTM) versus rigid cystoscopy at the time of hysterectomy. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Detection of urinary tract injuries | At the time of surgery | Identification of urinary tract injuries due to index procedure at time of cystoscopy |
| Device feasibility | At the time of surgery | Number of patients who were randomized to the novel urinary access system (CystosureTM) who could not receive the device due to technical issues (unable to insert catheter; device malfunction; surgeon preference) |
| Surgeon satisfaction | 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). | Survey will be collected from surgeons after the first and last use of CystoSureTM. |
Countries
United States
Contacts
Primary ContactCaroline Sabatino, MPH, CCRP
Backup ContactCharbel Salamon, MD, MS
Outcome results
None listed