N/A
Completed N=61
e۰Sense® Catheter Clinical Investigation
Urodynamics
Source: ClinicalTrials.gov NCT04438499 ↗
Enrolled (actual)
61
Serious AEs
0.0%
Results posted
Sep 2022
Primary outcomePrimary: Clinician Safety and Effectiveness Rating of eSense Catheters (Per Patient) — 58 Participants
Summary
This pre-market study will be conducted on consenting patients undergoing a medically prescribed, invasive, conventional urodynamics (UDS) test using the investigational device (e۰Sense® urodynamic catheters). Data pertaining to the safety, effectiveness and usability of the catheters will be collected.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Clinician Safety and Effectiveness Rating of eSense Catheters (Per Patient) |
58 | — |
| SECONDARY To Report the Percentage of Participants Free From Severe Complication for the Updated e۰Sense Catheters |
61 | — |
Eligibility Criteria
Inclusion Criteria
- Male and Female subjects (Age: 21 years and over) who are medically indicated for UDS testing.
Exclusion Criteria
- Subjects with significant cognitive deficiency that prevent the subject from giving informed consent
- Subjects suffering from an active bladder infection (not including subjects with asymptomatic bacteriuria)
- Pregnant women
- Subjects with recent (less than 2 weeks) pelvic floor surgery
- Subjects who require the use of a suprapubic catheter
Data sourced from ClinicalTrials.gov (NCT04438499). 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.