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

NCT03503175 | Unknown FDA Device

• 1 other identifier: 1178748
• Study Type: interventional
• Target: 364
• Locations: 1 country
• Sites: 1

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.

Conditions

Hysterectomy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Detection of urinary tract injuries

  At the time of surgery

• Device feasibility

  At the time of surgery

• Surgeon satisfaction

  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).

Study Arms (2)

Novel urinary access system

EXPERIMENTAL

Participants randomized to this arm will receive the novel urinary access system (CystoSureTM).

Device: Novel urinary access system (CystoSureTM)

Standard Foley catheter

ACTIVE COMPARATOR

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

Device: Standard Foley catheter

Interventions

Novel urinary access system (CystoSureTM) DEVICE

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).

Novel urinary access system

Standard Foley catheter DEVICE

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

Standard Foley catheter

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Women age 18-90
• Undergoing hysterectomy with or without concomitant procedures

You may not qualify if:

• 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

Sponsors & Collaborators

• Atlantic Health System: lead

Study Sites (1)

Atlantic Urogynecology Associates

Morristown, New Jersey, 07960, United States

RECRUITING

Central Study Contacts

Caroline Sabatino, MPH, CCRP

CONTACT

973-971-7361; caroline.sabatino@atlantichealth.org

Charbel Salamon, MD, MS

CONTACT

973-971-7267; charbel.salamon@atlantichealth.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator; Director, Urogynecology

Study Record Dates

• First Submitted: April 2, 2018
• First Posted: April 19, 2018
• Study Start: July 26, 2018
• Primary Completion: February 1, 2022
• Study Completion: March 1, 2022
• Last Updated: July 28, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)