N/A
Completed N=25
Air-charged vs Water-filled Catheters (Bonn)
Urodynamics
Source: ClinicalTrials.gov NCT02756182 ↗
Enrolled (actual)
25
Serious AEs
0.0%
Results posted
Sep 2019
Primary outcomePrimary: Maximum Vesical Pressure During Valsalva Manoeuvres — 39.31; 39.44 cmH2O
Summary
A comparative study was conducted and the patient underwent a conventional urodynamic study. In order to successfully determine if the Air-Charged (AC) and Water-Perfused (WP) measurements are equivalent, the two sources of intravesical pressure (Pves) and abdominal pressure (Pabd) were collected concurrently at various fill volumes for the bladder.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Maximum Vesical Pressure During Valsalva Manoeuvres |
39.31; 39.44 | — |
| PRIMARY Maximum Abdominal Pressure During Valsalva Manoeuvres |
37.93; 38.11 | — |
| PRIMARY Maximum Detrusor Pressure at Valsalva Manoeuvres |
1.72; 1.65 | — |
| SECONDARY Maximum Vesical Pressure During Coughs |
64.59; 69.65 | — |
| SECONDARY Maximum Abdominal Pressure During Coughs |
60.71; 63.01 | — |
| SECONDARY Maximum Detrusor Pressure During Coughs |
3.89; 6.83 | — |
Eligibility Criteria
Inclusion Criteria
- Patients normally indicated for urodynamic evaluations
Exclusion Criteria
- Patients who suffer from bladder infections (not including patients with asymptomatic bacteruria, prophylaxis with an antibiotic is at the discretion of the physician)
- Patients who suffer from strictures in the urethra
- Patients who are pregnant
- Patients who require the use of a suprapubic catheter
Data sourced from ClinicalTrials.gov (NCT02756182). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.