HysterectomyNCT03503175
A Novel Urinary Access System for Universal Transcatheter Cystoscopy at The Time of Hysterectomy
A study testing Novel urinary access system (CystoSureTM) and Standard Foley catheter in people with Hysterectomy, run by Atlantic Health System at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 90 years, women only
- Conditions the study is for
- Hysterectomy
- What is being tested?
- Novel urinary access system (CystoSureTM) and Standard Foley catheter
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 364 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Jul 2018to 1 Mar 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women age 18-90
- Undergoing hysterectomy with or without concomitant procedures
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Atlantic Urogynecology Associates
Morristown, New Jersey, 07960
Caroline Sabatino, MPH, CCRP, 973-971-7361
Charbel G Salamon, MD, MS
About this study
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.
Read the 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.
- Conditions
- Hysterectomy
- Being tested
- Novel urinary access system (CystoSureTM), Standard Foley catheter
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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).
Standard Foley catheterDevice
Participants randomized to this arm will receive a standard Foley catheter and standard rigid cystoscopy.
| Study group | Role | What they receive |
|---|---|---|
| Novel urinary access system | Experimental | Participants randomized to this arm will receive the novel urinary access system (CystoSureTM). Receives: 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. Receives: Device: Standard Foley catheter |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 4 weeks after surgery
Secondary outcomes (3)
Detection of urinary tract injuries
Identification of urinary tract injuries due to index procedure at time of cystoscopy
Measured: 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)
Measured: At the time of surgery
Surgeon satisfaction
Survey will be collected from surgeons after the first and last use of CystoSureTM.
Measured: 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).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2018
- Study start26 Jul 2018
- Primary completion1 Feb 2022 (estimated)
- Study completion1 Mar 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HysterectomyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 364 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Atlantic Health System
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, charbel salamon, Atlantic Health System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03503175
- Sponsor's protocol ID
- 1178748
- Status last verified
- Jul 2020
- First submitted
- 2 Apr 2018
- Last updated
- 28 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Novel Urinary Access System for Universal Transcatheter Cystoscopy at The Time of Hysterectomy
- ClinicalTrials.gov ID
- NCT03503175
- Acronym / sponsor ID
- 1178748
- Conditions
- Hysterectomy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 364 participants (estimated)
- Lead sponsor
- Atlantic Health SystemUniversity, hospital or other
- Study start
- 26 Jul 2018 (actual)
- Primary completion
- 1 Feb 2022 (estimated)
- Study completion
- 1 Mar 2022 (estimated)
- First posted
- 19 Apr 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Novel urinary access system | Experimental | Device: Novel urinary access system (CystoSureTM)Participants randomized to this arm will receive the novel urinary access system (CystoSureTM). |
| Standard Foley catheter | Active comparator | Device: Standard Foley catheterParticipants randomized to this arm will receive a standard Foley catheter and rigid cystoscopy. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Women age 18-90
- Undergoing hysterectomy with or without concomitant procedures
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Novel urinary access system |
| Standard Foley catheterParticipants randomized to this arm will receive a standard Foley catheter and standard rigid cystoscopy. | Device | Standard Foley catheter |
Primary outcome
Urinary tract infections
Time frame: Up to 4 weeks after surgery
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.
3 secondary outcomes
Detection of urinary tract injuries
Time frame: At the time of surgery
Device feasibility
Time frame: At the time of surgery
Surgeon satisfaction
Time frame: 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).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Novel urinary access system (CystoSureTM) and Standard Foley catheter in people with Hysterectomy, run by Atlantic Health System at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Caroline Sabatino, MPH, CCRP (973-971-7361, caroline.sabatino@atlantichealth.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Urinary tract infections (time frame: Up to 4 weeks after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2020.