N/A
Completed N=12
Exploratory Investigation of Data Obtained From a Sensor Connected to an Intermittent Catheter
Compliance, Patient
Source: ClinicalTrials.gov NCT04250987 ↗
Enrolled (actual)
12
Serious AEs
0.0%
Results posted
Sep 2020
Primary outcomePrimary: Number of Participants With Readability of Pressure Sensor Measurements — 11 Participants
Summary
The purpose of the investigational device in the proposed clinical investigation is to capture pressure data prior to and during voiding using a CE-marked commercially available catheter.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Readability of Pressure Sensor Measurements |
11 | — |
Eligibility Criteria
Inclusion Criteria
- Have given written informed consent
- Be at least 18 years of age and have full legal capacity
Exclusion Criteria
- Previous history of genitourinary disease in-cluding congenital abnormalities and surgical procedures performed in the urinary tract
- Symptoms of urinary tract infections (fre-quent urination, stinging and pain at urina-tion)
- Participation in any other clinical investiga-tions during this investigation (Inclusion → termination)
- Known hypersensitivity toward any of the test products
- Positive pregnancy tes for women
Data sourced from ClinicalTrials.gov (NCT04250987). 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.