Urethral DiseasesNCT03066999
DirectVision for Urinary Catheterization
A study testing Cystoscopy and DirectVision in people with Urethral Diseases, run by The Pur Clinic at 1 site in United States.
Trial summary
The Center for Disease Control and Prevention (CDC) reports that one in four patients hospitalized in the United States is catheterized to void the bladder or monitor urinary output. In the male population, Dr. Singh, an urologist estimates that about 20% of catheterizations are difficult. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Urethral Diseases
- What is being tested?
- Cystoscopy and DirectVision
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Mar 2017to 1 Oct 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Any patient over 18 years with a standard indication for difficult urinary catheterization
Who cannot join
- Any patient younger than 18 years of age, pregnant patients
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessment of the Effectiveness and Ease of Use of DirectVision- a Direct Visualization System for Urinary Catheterization: Results of a Single Center Prospective Study
The Center for Disease Control and Prevention (CDC) reports that one in four patients hospitalized in the United States is catheterized to void the bladder or monitor urinary output. In the male population, Dr. Singh, an urologist estimates that about 20% of catheterizations are difficult. Driving a catheter blindly, guessing whether to push the catheter forward or manipulate it to get around a point of resistance leads to the risk of injury which increases the more the catheter is manipulated. Additional adverse events include: urosepsis, UTI and bladder perforation. The standard of care treatment for patients with difficult urinary catheterization (DUC) is to proceed with a cystoscopic catheter placement or suprapubic tube placement.
PercuVision has the only Foley catheter with a micro-endoscope for visualization and navigation of the urethra for nurses and other qualified health care professionals. Moreover, it allows urologists to place a guidewire under direct vision rather than calling for a flexible cystoscope which is considered a minor procedure.
In this study, the investigators plan on assessing the effectiveness and ease of use of the PercuVision DirectVision® System device.
Read the detailed description
Routine placement of transurethral catheters can be challenging in some situations, such as urethral strictures, severe phimosis and false passages. Intravaginal retraction of the urethral meatus can complicate Foley placement in postmenopausal females. In men, blind urethral procedures with mechanical or metal sounds without visual guidance or guidewire assistance are now discouraged due to the increased risk of urethral trauma and false passages.
DirectVision is a new visually-guided catheterization device (VGCD) that uses a camera visual guide / microendoscope within a triple lumen flexible urinary catheter with an angled tip, essentially combining the functionality of a urinary catheter with a cystoscope. DirectVision uses fiber-optic bundle of 6,000 integrated fibers to provide illumination and transmit real-time video.
Procedures done via flexible cystoscopy or DirectVision are covered by insurance (including Medicaid/Medicare).
In this prospective study, the investigators plan on assessing the effectiveness and ease of use of DirectVision - A direct visualization system for urinary catheterization.
- Conditions
- Urethral Diseases
- Being tested
- Cystoscopy, DirectVision
- Medical subject headings
- Urethral Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CystoscopyProcedure or surgery
Patients will assign to either Group Cystoscopy (catheter placement via cystoscopy)
DirectVisionDevice
Patients will assign to either Group DirectVision (catheter placement via DirectVision)
| Study group | Role | What they receive |
|---|---|---|
| Cystoscopy | Active comparator | will have catheter placement using the cystoscopy method Receives: Procedure: Cystoscopy |
| DirectVision | Active comparator | will have catheter placement using DirectVision. Receives: Device: DirectVision |
What is being measured
The primary outcome is the main question the study is designed to answer.
Set up Time/Total Procedure Time to Place Catheter Via DirectVision/Cystoscope
Duration to set up and complete the procedure either by DirectVision or Cystoscope was observed and calculated by minutes.
Measured: prep and duration of procedure, up to 1 hour
Effectiveness of DirectVision-adverse Events
assessment will be done by reviewing the number of Participants who had adverse events that are related to the procedures.
Measured: 7 months
Ancillary Tools Used
Ancillary tools used wire, SPT, etc
Measured: duration of procedure
Procedure Findings
Procedure findings
- 1- Obliterated urethra
- 2-High bladder neck
- 3-Normal urethra
- 4-Urethral stricture
- 5-Bladder neck contracture
Measured: duration of procedure
Degree of Difficulty
Degree of difficulty defined as easy versus difficult
Measured: duration of procedure
Presence of Pain and Hematuria
To compare DirectVision to the cystoscope we compared if patients experienced pain or hematuria
Measured: duration of procedure
Secondary outcomes (1)
Cost to Use Cystoscope Versus DirectVision
The investigators will look at the cost using the DirectVision versus the cystoscope with costs of ancillary tools used during the procedures.
Measured: 7 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2017
- Study start7 Mar 2017
- Primary completion1 Oct 2017
- Study completion1 Oct 2017
Why it stopped: There was no enough subject
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Urethral DiseasesStudies 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Pur Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- PercuVision
- Responsible party
- Principal investigator, Sijo J. Parekattil, M.D., The Pur Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03066999
- Sponsor's protocol ID
- 16.129.10
- Status last verified
- Jul 2019
- First submitted
- 8 Feb 2017
- Last updated
- 30 Jul 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: We will keep the IPD within the research group
Publications
Ghaffary C, Yohannes A, Villanueva C, Leslie SW. A practical approach to difficult urinary catheterizations. Curr Urol Rep. 2013 Dec;14(6):565-79. doi: 10.1007/s11934-013-0364-3.
PubMed 23959835
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Effectiveness and Ease of Use of DirectVision- a Direct Visualization System for Urinary Catheterization: Results of a Single Center Prospective Study
- ClinicalTrials.gov ID
- NCT03066999
- Acronym / sponsor ID
- 16.129.10
- Conditions
- Urethral Diseases
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: There was no enough subject
- Enrolment
- 5 participants (actual)
- Lead sponsor
- The Pur ClinicUniversity, hospital or other
- Collaborators
- PercuVision
- Study start
- 7 Mar 2017 (actual)
- Primary completion
- 1 Oct 2017 (actual)
- Study completion
- 1 Oct 2017 (actual)
- First posted
- 1 Mar 2017 (actual)
- Results
- Posted 30 Jul 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The Center for Disease Control and Prevention (CDC) reports that one in four patients hospitalized in the United States is catheterized to void the bladder or monitor urinary output. In the male population, Dr. Singh, an urologist estimates that about 20% of catheterizations are difficult. Driving a catheter blindly, guessing whether to push the catheter forward or manipulate it to get around a point of resistance leads to the risk of injury which increases the more the catheter is manipulated. Additional adverse events include: urosepsis, UTI and bladder perforation. The standard of care treatment for patients with difficult urinary catheterization (DUC) is to proceed with a cystoscopic catheter placement or suprapubic tube placement.
PercuVision has the only Foley catheter with a micro-endoscope for visualization and navigation of the urethra for nurses and other qualified health care professionals. Moreover, it allows urologists to place a guidewire under direct vision rather than calling for a flexible cystoscope which is considered a minor procedure.
In this study, the investigators plan on assessing the effectiveness and ease of use of the PercuVision DirectVision® System device.
Detailed description
Routine placement of transurethral catheters can be challenging in some situations, such as urethral strictures, severe phimosis and false passages. Intravaginal retraction of the urethral meatus can complicate Foley placement in postmenopausal females. In men, blind urethral procedures with mechanical or metal sounds without visual guidance or guidewire assistance are now discouraged due to the increased risk of urethral trauma and false passages.
DirectVision is a new visually-guided catheterization device (VGCD) that uses a camera visual guide / microendoscope within a triple lumen flexible urinary catheter with an angled tip, essentially combining the functionality of a urinary catheter with a cystoscope. DirectVision uses fiber-optic bundle of 6,000 integrated fibers to provide illumination and transmit real-time video.
Procedures done via flexible cystoscopy or DirectVision are covered by insurance (including Medicaid/Medicare).
In this prospective study, the investigators plan on assessing the effectiveness and ease of use of DirectVision - A direct visualization system for urinary catheterization.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cystoscopy | Active comparator | Procedure: Cystoscopywill have catheter placement using the cystoscopy method |
| DirectVision | Active comparator | Device: DirectVisionwill have catheter placement using DirectVision. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Any patient over 18 years with a standard indication for difficult urinary catheterization
Key exclusion criteria (1 listed)
- Any patient younger than 18 years of age, pregnant patients
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 |
|---|---|---|
| CystoscopyPatients will assign to either Group Cystoscopy (catheter placement via cystoscopy) | Procedure or surgery | Cystoscopy |
| DirectVisionPatients will assign to either Group DirectVision (catheter placement via DirectVision) | Device | DirectVision |
Primary outcome
Set up Time/Total Procedure Time to Place Catheter Via DirectVision/Cystoscope
Time frame: prep and duration of procedure, up to 1 hour
Duration to set up and complete the procedure either by DirectVision or Cystoscope was observed and calculated by minutes.
Effectiveness of DirectVision-adverse Events
Time frame: 7 months
assessment will be done by reviewing the number of Participants who had adverse events that are related to the procedures.
Ancillary Tools Used
Time frame: duration of procedure
Ancillary tools used wire, SPT, etc
Procedure Findings
Time frame: duration of procedure
Procedure findings * 1- Obliterated urethra * 2-High bladder neck * 3-Normal urethra * 4-Urethral stricture * 5-Bladder neck contracture
Degree of Difficulty
Time frame: duration of procedure
Degree of difficulty defined as easy versus difficult
Presence of Pain and Hematuria
Time frame: duration of procedure
To compare DirectVision to the cystoscope we compared if patients experienced pain or hematuria
1 secondary outcome
Cost to Use Cystoscope Versus DirectVision
Time frame: 7 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 23959835Ghaffary C, Yohannes A, Villanueva C, Leslie SW. A practical approach to difficult urinary catheterizations. Curr Urol Rep. 2013 Dec;14(6):565-79. doi: 10.1007/s11934-013-0364-3.
- Feasibility study of a visually guided male urinary catheterization device by Banks et al.Journal of Urology. 2009; 181(4): p454.Link provided by the sponsor.
- Individual participant dataSharing planned: No. We will keep the IPD within the research group
Related trials for Urethral Diseases
Recruiting
Comparing Rezum and Urolift
Benign Prostatic Hyperplasia
Recruiting
24 Gy in One Fraction Urethral-sparing "HDR Like" SBRT for Prostate Cancer
Localized Prostate Carcinoma
RecruitingPhase 2
Testing the Effectiveness of Two Immunotherapy Drugs (Nivolumab and Ipilimumab) With One Anti-cancer Targeted Drug (Cabozantinib) for Rare Genitourinary Tumors
Bladder Adenocarcinoma, Bladder Clear Cell Adenocarcinoma
Active, not recruitingPhase 3
Testing the Addition of the Anti-cancer Drug, Cabozantinib, to the Usual Immunotherapy Treatment, Avelumab, in Patients With Metastatic Urothelial Cancer, MAIN-CAV Study
Advanced Bladder Urothelial Carcinoma, Advanced Renal Pelvis Urothelial Carcinoma
Active, not recruitingPhase 3
Autologous Muscle Derived Cells Compared to Placebo for Urinary Sphincter Repair in Post-surgical Female Stress Incontinence
Stress Urinary Incontinence
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cystoscopy and DirectVision in people with Urethral Diseases, run by The Pur Clinic 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 1 inclusion and 1 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: stopped early, as of the sponsor's last update on 30 Jul 2019. 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?
Yes. Results are posted in the registry (first posted 30 Jul 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Set up Time/Total Procedure Time to Place Catheter Via DirectVision/Cystoscope (time frame: prep and duration of procedure, up to 1 hour). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03066999, which also lists 1 linked publication.
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 30 Jul 2019.