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

Hysterectomy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03503175
• Other study ID #: 1178748
• Status: Recruiting
• Phase: N/A
• Start date: July 26, 2018
• Est. completion date: March 1, 2022

Study information

• Verified date: July 2020
• Source: Atlantic Health System
• Contact: Caroline Sabatino, MPH, CCRP
• Phone: 973-971-7361
• Email: caroline.sabatino[@]atlantichealth.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 364
• Est. completion date: March 1, 2022
• Est. primary completion date: February 1, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Hysterectomy

Intervention

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

Locations

Country	Name	City	State
United States	Atlantic Urogynecology Associates	Morristown	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Atlantic Health System

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Detection of urinary tract injuries	Identification of urinary tract injuries due to index procedure at time of cystoscopy	At the time of surgery
Secondary	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
Secondary	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).