Trial Outcomes & Findings for Portable Pves Study (NCT NCT02673944)
NCT ID: NCT02673944
Last Updated: 2016-06-24
Results Overview
To validate that the Peritron+ digital readings are identical to the urodynamic readings (+/- 3 cm H2O) in the sitting position.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
10 participants
Primary outcome timeframe
During a routine urodynamic study (1 hr approx)
Results posted on
2016-06-24
Participant Flow
Participant milestones
| Measure |
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
|
|---|---|
|
Overall Study
STARTED
|
10
|
|
Overall Study
COMPLETED
|
10
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Portable Pves Study
Baseline characteristics by cohort
| Measure |
Peritron+
n=10 Participants
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
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
8 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Peritron+
n=10 Participants
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
|
Standard Urodynamic Analyzer
n=10 Participants
Patients will undergo a routine urodynamic evaluation, which will collect both Peritorn+ and UDS data.
|
|---|---|---|
|
Accurate Vesical PRessure
|
18.56 cm H2O
Standard Deviation 8.29
|
17.45 cm H2O
Standard Deviation 7.85
|
Adverse Events
Peritron+
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place