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

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.

Study Overview

• Status: Unknown
• Conditions: Hysterectomy
• Intervention / Treatment: Device: Novel urinary access system (CystoSureTM); Device: Standard Foley catheter

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 Type: Interventional
• Enrollment (Anticipated): 364
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New Jersey
    • Morristown, New Jersey, United States, 07960
      • Recruiting
      • Atlantic Urogynecology Associates
      • Contact: Caroline Sabatino, MPH, CCRP; Phone Number: 973-971-7361
      • Principal Investigator: Charbel G Salamon, MD, MS

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

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).

Collaborators and Investigators

• Sponsor: Atlantic Health System

Study record dates

Study Major Dates

• Study Start (Actual): July 26, 2018
• Primary Completion (Anticipated): February 1, 2022
• Study Completion (Anticipated): March 1, 2022

Study Registration Dates

• First Submitted: April 2, 2018
• First Submitted That Met QC Criteria: April 18, 2018
• First Posted (Actual): April 19, 2018

Study Record Updates

• Last Update Posted (Actual): July 28, 2020
• Last Update Submitted That Met QC Criteria: July 26, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: 1178748

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• 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