Lower Urinary Tract Symptoms
Conditions
Brief summary
A comparative study will be conducted and the patient will undergo a conventional urodynamic study. In order to successfully determine if the Peritron+ is capturing vesical pressure measurements consistent with conventional urodynamics the two sources of Pves will be collected concurrently.
Interventions
DEVICEPeritron+
Peritron+ will be connected to a standard urodynamic analyzer system to measure vesical pressure
Sponsors
Laborie Medical Technologies Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients normally indicated for urodynamic evaluation
Exclusion criteria
* Patients who suffer from bladder infections * Patients who suffer from strictures in the urethra
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Accurate Vesical PRessure | During a routine urodynamic study (1 hr approx) | To validate that the Peritron+ digital readings are identical to the urodynamic readings (+/- 3 cm H2O) in the sitting position. |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Peritron+ Patients will undergo a routine urodynamic evaluation, the Peritron+ will be used in conjunction with a water-based urodynamic catheter
Peritron+: Peritron+ will be connected to a standard urodynamic analyzer system to measure vesical pressure | 10 |
| Total | 10 |
Baseline characteristics
| Characteristic | Peritron+ |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 2 Participants |
| Age, Categorical Between 18 and 65 years | 8 Participants |
| Sex: Female, Male Female | 10 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 10 |
| serious Total, serious adverse events | 0 / 10 |
Outcome results
Primary
Accurate Vesical PRessure
To validate that the Peritron+ digital readings are identical to the urodynamic readings (+/- 3 cm H2O) in the sitting position.
Time frame: During a routine urodynamic study (1 hr approx)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Peritron+ | Accurate Vesical PRessure | 18.56 cm H2O | Standard Deviation 8.29 |
| Standard Urodynamic Analyzer | Accurate Vesical PRessure | 17.45 cm H2O | Standard Deviation 7.85 |