Recruiting

Observational Study

Sponsor:

Atlantic Health System

Code:

NCT03503175

Conditions

Hysterectomy

Eligibility Criteria

Sex: Female

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Novel urinary access system (CystoSureTM)

Standard Foley catheter

Study Details

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

Study ID

NCT03503175

Start date

Jul 26, 2018

Status verified date

Jul, 2020

Completion date

Mar 1, 2022

Anticipated

Primary completion date

Feb 1, 2022

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18 - 70+

Healthy Volunteers: Not accepted

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 Design

Enrollment

364 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Novel urinary access system

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

active comparator: Standard Foley catheter

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

Interventions

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.

Primary outcome measure

  • Urinary tract infections [ Time Frame: Up to 4 weeks after surgery ]

Central Contacts and Locations

Central contacts

Caroline Sabatino, MPH, CCRP

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

Charbel Salamon, MD, MS

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

Locations

Atlantic Urogynecology Associates

Recruiting

Morristown, New Jersey, United States, 07960

Contacts

Caroline Sabatino, MPH, CCRP

973-971-7361

Principal Investigator:

Charbel G Salamon, MD, MS

More Information

Sponsor

Atlantic Health System

Last update posted

Jul 28, 2020

Last verified

Jul, 2020

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Atlantic Health System on 2020-07-28.