Urethral Diseases
Conditions
Brief 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. 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.
Interventions
PROCEDURECystoscopy
Patients will assign to either Group Cystoscopy (catheter placement via cystoscopy)
DEVICEDirectVision
Patients will assign to either Group DirectVision (catheter placement via DirectVision)
Sponsors
PercuVision
The Pur Clinic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Any patient over 18 years with a standard indication for difficult urinary catheterization
Exclusion criteria
* Any patient younger than 18 years of age, pregnant patients
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Ancillary Tools Used | duration of procedure | Ancillary tools used wire, SPT, etc |
| Set up Time/Total Procedure Time to Place Catheter Via DirectVision/Cystoscope | 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 | 7 months | assessment will be done by reviewing the number of Participants who had adverse events that are related to the procedures. |
| Presence of Pain and Hematuria | duration of procedure | To compare DirectVision to the cystoscope we compared if patients experienced pain or hematuria |
| Procedure Findings | 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 | duration of procedure | Degree of difficulty defined as easy versus difficult |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cost to Use Cystoscope Versus DirectVision | 7 months | The investigators will look at the cost using the DirectVision versus the cystoscope with costs of ancillary tools used during the procedures. |
Countries
United States
Participant flow
Pre-assignment details
No enrolled patients were excluded from the study before assignment to groups
Participants by arm
| Arm | Count |
|---|---|
| Cystoscopy will have catheter placement using the cystoscopy method | 2 |
| DirectVision will have catheter placement using DirectVision | 3 |
| Total | 5 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | abnormal urethraBladder neck contracture | 0 | 2 |
Baseline characteristics
| Characteristic | Cystoscopy | DirectVision | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 2 Participants | 3 Participants | 5 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| History of urological procedures | 2 Participants | 2 Participants | 4 Participants |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 2 Participants | 3 Participants | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 2 | 0 / 3 |
| other Total, other adverse events | 0 / 2 | 0 / 3 |
| serious Total, serious adverse events | 0 / 2 | 0 / 3 |
Outcome results
Primary
Ancillary Tools Used
Ancillary tools used wire, SPT, etc
Time frame: duration of procedure
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cystoscopy | Ancillary Tools Used | 2 tools |
| DirectVision | Ancillary Tools Used | 2 tools |
Primary
Degree of Difficulty
Degree of difficulty defined as easy versus difficult
Time frame: duration of procedure
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cystoscopy | Degree of Difficulty | Easy | 2 Participants |
| Cystoscopy | Degree of Difficulty | Difficult | 0 Participants |
| DirectVision | Degree of Difficulty | Easy | 1 Participants |
| DirectVision | Degree of Difficulty | Difficult | 2 Participants |
Primary
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.
Time frame: 7 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cystoscopy | Effectiveness of DirectVision-adverse Events | 0 Participants |
| DirectVision | Effectiveness of DirectVision-adverse Events | 0 Participants |
Primary
Presence of Pain and Hematuria
To compare DirectVision to the cystoscope we compared if patients experienced pain or hematuria
Time frame: duration of procedure
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cystoscopy | Presence of Pain and Hematuria | Presence of hematuria | 1 participants |
| Cystoscopy | Presence of Pain and Hematuria | Presence of pain | 0 participants |
| DirectVision | Presence of Pain and Hematuria | Presence of hematuria | 1 participants |
| DirectVision | Presence of Pain and Hematuria | Presence of pain | 0 participants |
Primary
Procedure Findings
Procedure findings * 1- Obliterated urethra * 2-High bladder neck * 3-Normal urethra * 4-Urethral stricture * 5-Bladder neck contracture
Time frame: duration of procedure
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cystoscopy | Procedure Findings | High bladder neck | 1 participants |
| Cystoscopy | Procedure Findings | Urethral stricture | 1 participants |
| Cystoscopy | Procedure Findings | Obliterated urethra | 0 participants |
| Cystoscopy | Procedure Findings | Bladder neck contracture | 0 participants |
| Cystoscopy | Procedure Findings | Normal urethral profile | 0 participants |
| DirectVision | Procedure Findings | Bladder neck contracture | 1 participants |
| DirectVision | Procedure Findings | High bladder neck | 0 participants |
| DirectVision | Procedure Findings | Normal urethral profile | 1 participants |
| DirectVision | Procedure Findings | Urethral stricture | 0 participants |
| DirectVision | Procedure Findings | Obliterated urethra | 1 participants |
Primary
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.
Time frame: prep and duration of procedure, up to 1 hour
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Cystoscopy | Set up Time/Total Procedure Time to Place Catheter Via DirectVision/Cystoscope | Set up time- in minutes | 15 minutes |
| Cystoscopy | Set up Time/Total Procedure Time to Place Catheter Via DirectVision/Cystoscope | procedure time | 5 minutes |
| DirectVision | Set up Time/Total Procedure Time to Place Catheter Via DirectVision/Cystoscope | Set up time- in minutes | 26.67 minutes |
| DirectVision | Set up Time/Total Procedure Time to Place Catheter Via DirectVision/Cystoscope | procedure time | 23.33 minutes |
Secondary
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.
Time frame: 7 months
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Cystoscopy | Cost to Use Cystoscope Versus DirectVision | 174 Cost in dollars per patient |
| DirectVision | Cost to Use Cystoscope Versus DirectVision | 187 Cost in dollars per patient |