A Novel Urinary Access System for Universal Transcatheter Cystoscopy at The Time of Hysterectomy

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Novel Urinary Access System for Universal Transcatheter Cystoscopy at The Time of Hysterectomy

Conditions
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Hysterectomy

Intervention / Treatment
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* Device: Novel urinary access system (CystoSureTM)
* Device: Standard Foley catheter


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Novel urinary access system<br>Participants randomized to this arm will receive the novel urinary access system (CystoSureTM). | Device: Novel urinary access system (CystoSureTM)<br>* 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).<br>|
| Active Comparator: Standard Foley catheter<br>Participants randomized to this arm will receive a standard Foley catheter and rigid cystoscopy. | Device: Standard Foley catheter<br>* Participants randomized to this arm will receive a standard Foley catheter and standard rigid cystoscopy.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Urinary tract infections | 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. | Up to 4 weeks after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Detection of urinary tract injuries | Identification of urinary tract injuries due to index procedure at time of cystoscopy | At the time of surgery | 
| Device feasibility | 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) | At the time of surgery | 
| Surgeon satisfaction | Survey will be collected from surgeons after the first and last use of CystoSureTM. | 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). |