Urodynamics, Urologic Diseases
Conditions
Keywords
Lower Urinary Tract Dysfunction, Urinary Incontinence, Overactive Bladder, Urodynamics, Uroflowmetry
Brief summary
The goal of this prospective trial is to evaluate the feasibility, efficacy, and safety of the Glean Urodynamics System (GUS) for use in the clinic to collect vesical pressure data in adult males and females with lower urinary tract symptoms. The main question\[s\] it aims to answer are: • What is the feasibility, efficacy, and safety of GUS for use in clinical to collect vesical pressure data in adult males and females with lower urinary tract symptoms? Participants will undergo a planned conventional urodynamics exam after which the Glean Sensor will be inserted and ambulatory urodynamics will be performed with the sensor indwelling in the bladder after which the sensor will be removed.
Interventions
DEVICEGlean Urodynamics System
Wireless, catheter-free urodynamics system
Sponsors
Bright Uro
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DEVICE_FEASIBILITY
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Male or female patient must be ≥ 18 years of age * Patient must have a diagnosis of LUTD * Patient must be scheduled for or recommended for cUDS * Patient is able to tolerate 18Fr catheterization * Patient or patient's legally authorized representative is able to provide informed consent
Exclusion criteria
* Pregnant (as confirmed by urine pregnancy test) or breastfeeding, pregnant within the past 6 months or intend to become pregnant during the study period. * Patient has a symptomatic UTI based on CDC guidance (see below) * Subjects who, at the principal investigator's determination, would not be appropriate for this study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Insertion Success | during the insertion procedure of a device | Percent of insertion attempts of the Glean sensor deemed successful |
| Percentage of Participants With a Device-related SAE | up to 2 weeks | Device-related serious adverse events |
| Percentage of Participants With Removal Success | during the removal procedure of a device | Percent of removal attempts of the Glean sensor deemed successful |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Rating Overall Comfort of Glean Urodynamics as Comfortable or Extremely Comfortable | asked at end of Glean Urodynamics procedure | Number of participants rating the overall comfort of Glean Urodynamics at comfortable or extremely comfortable |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Glean Urodynamics System Wireless, catheter-free urodynamics system | 38 |
| Total | 38 |
Baseline characteristics
| Characteristic | Glean Urodynamics System |
|---|---|
| Age, Customized Age | 64 Years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 35 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 6 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 32 Participants |
| Sex: Female, Male Female | 17 Participants |
| Sex: Female, Male Male | 21 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 38 | 0 / 32 |
| other Total, other adverse events | 12 / 38 | 7 / 32 |
| serious Total, serious adverse events | 0 / 38 | 0 / 32 |
Outcome results
Primary
Percentage of Participants With a Device-related SAE
Device-related serious adverse events
Time frame: up to 2 weeks
Population: Number of participants undergoing Glean Urodynamics
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Glean Urodynamics System | Percentage of Participants With a Device-related SAE | 0 Participants |
Primary
Percentage of Participants With Insertion Success
Percent of insertion attempts of the Glean sensor deemed successful
Time frame: during the insertion procedure of a device
Population: 33/34 participants who underwent conventional urodynamics underwent an insertion attempt with the Glean Urodynamics System.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Glean Urodynamics System | Percentage of Participants With Insertion Success | 32 Participants |
Primary
Percentage of Participants With Removal Success
Percent of removal attempts of the Glean sensor deemed successful
Time frame: during the removal procedure of a device
Population: 32 participants had Glean successfully inserted and thus all had a successful removal.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Glean Urodynamics System | Percentage of Participants With Removal Success | 32 Participants |
Secondary
Percentage of Participants Rating Overall Comfort of Glean Urodynamics as Comfortable or Extremely Comfortable
Number of participants rating the overall comfort of Glean Urodynamics at comfortable or extremely comfortable
Time frame: asked at end of Glean Urodynamics procedure
Population: Number of participants who experienced Glean Urodynamics and completed the survey at the end of the urodynamics study visit
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Glean Urodynamics System | Percentage of Participants Rating Overall Comfort of Glean Urodynamics as Comfortable or Extremely Comfortable | 13 Participants |