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

NAUnknownINTERVENTIONAL
Enrollment

364

Participants

Timeline

Start Date

July 26, 2018

Primary Completion Date

February 1, 2022

Study Completion Date

March 1, 2022

Conditions
Hysterectomy
Interventions
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).

DEVICE

Standard Foley catheter

Participants randomized to this arm will receive a standard Foley catheter and standard rigid cystoscopy.

Trial Locations (1)

07960

RECRUITING

Atlantic Urogynecology Associates, Morristown

Sponsors
All Listed Sponsors
lead

Atlantic Health System

OTHER

NCT03503175 - A Novel Urinary Access System for Universal Transcatheter Cystoscopy at The Time of Hysterectomy | Biotech Hunter | Biotech Hunter