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

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ClinicalTrials.gov Identifier: NCT03503175
Recruitment Status : Recruiting
First Posted : April 19, 2018
Last Update Posted : July 28, 2020
Sponsor:
Information provided by (Responsible Party):
charbel salamon, Atlantic Health System

Study Description
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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.

Condition or disease Intervention/treatment Phase
Hysterectomy Device: Novel urinary access system (CystoSureTM) Device: Standard Foley catheter Not Applicable

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 364 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: A Novel Urinary Access System for Universal Transcatheter Cystoscopy at The Time of Hysterectomy
Actual Study Start Date : July 26, 2018
Estimated Primary Completion Date : February 1, 2022
Estimated Study Completion Date : March 1, 2022

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Novel urinary access system
Participants randomized to this arm will receive the novel urinary access system (CystoSureTM).
 Device: Novel 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).
Active Comparator: Standard Foley catheter
Participants randomized to this arm will receive a standard Foley catheter and rigid cystoscopy.
 Device: Standard Foley catheter
Participants randomized to this arm will receive a standard Foley catheter and standard rigid cystoscopy.


Outcome Measures
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Primary Outcome Measures :
  1. Urinary tract infections [ Time Frame: 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 Outcome Measures :
  1. Detection of urinary tract injuries [ Time Frame: At the time of surgery ]
    Identification of urinary tract injuries due to index procedure at time of cystoscopy

  2. Device feasibility [ Time Frame: 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)

  3. Surgeon satisfaction [ Time Frame: 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03503175


Contacts
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Contact: Caroline Sabatino, MPH, CCRP 973-971-7361 caroline.sabatino@atlantichealth.org
Contact: Charbel Salamon, MD, MS 973-971-7267 charbel.salamon@atlantichealth.org

Locations
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United States, New Jersey
Atlantic Urogynecology Associates Recruiting
Morristown, New Jersey, United States, 07960
Contact: Caroline Sabatino, MPH, CCRP    973-971-7361      
Principal Investigator: Charbel G Salamon, MD, MS         
Sponsors and Collaborators
Atlantic Health System
More Information
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Responsible Party: charbel salamon, Principal Investigator; Director, Urogynecology, Atlantic Health System
ClinicalTrials.gov Identifier: NCT03503175    
Other Study ID Numbers: 1178748
First Posted: April 19, 2018    Key Record Dates
Last Update Posted: July 28, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No