A Novel Urinary Access System for Universal Transcatheter Cystoscopy at The Time of Hysterectomy
NCT ID: NCT03503175
Last Updated: 2020-07-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
364 participants
INTERVENTIONAL
2018-07-26
2022-03-01
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Novel urinary access system
Participants randomized to this arm will receive the novel urinary access system (CystoSureTM).
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).
Standard Foley catheter
Participants randomized to this arm will receive a standard Foley catheter and rigid cystoscopy.
Standard Foley catheter
Participants randomized to this arm will receive a standard Foley catheter and standard rigid cystoscopy.
Interventions
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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).
Standard Foley catheter
Participants randomized to this arm will receive a standard Foley catheter and standard rigid cystoscopy.
Eligibility Criteria
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Inclusion Criteria
* Undergoing hysterectomy with or without concomitant procedures
Exclusion Criteria
* ≥3 UTIs in past 6 months
* Immunosuppressed patients
* Premeditated urologic procedure during hysterectomy surgery
18 Years
90 Years
FEMALE
No
Sponsors
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Atlantic Health System
OTHER
Responsible Party
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charbel salamon
Principal Investigator; Director, Urogynecology
Locations
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Atlantic Urogynecology Associates
Morristown, New Jersey, United States
Countries
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Central Contacts
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Facility Contacts
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Caroline Sabatino, MPH, CCRP
Role: primary
Other Identifiers
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1178748
Identifier Type: -
Identifier Source: org_study_id
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