N/A
N=20
T-DOC® NXT Clinical Investigation
Incontinence, Urge
Bottom Line
View on ClinicalTrials.gov: NCT03615001 ↗Enrolled (actual)
20
Serious AEs
0.0%
Results posted
Jun 2020
Primary outcome: Primary: The Number of Patients in Which the T-DOC® NXT Catheters Are Safe in Measuring Urodynamic Pressure in Adults. — 20 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- TDOC NXT (Device)
- Age
- Adult, Older Adult · 21+ yrs
- Sex
- All
- Sponsor
- Laborie Medical Technologies Inc.
- Primary completion
- Oct 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Number of Patients in Which the T-DOC® NXT Catheters Are Safe in Measuring Urodynamic Pressure in Adults. |
20 | — |
| PRIMARY The Number of Patients in Which the T-DOC® NXT Catheters Are Effective in Measuring Urodynamic Pressure in Adults. |
20 | — |
Summary
Assessing the Performance, Safety and Usability of our Next Generation T-DOC® NXT Catheter for Performing Urodynamic Studies
Eligibility Criteria
Inclusion Criteria
- Male and Female (Adult age 21+)
- Patients with clinical indication for urodynamics (UDS) testing, for any medically necessary reason as per the physician.
Exclusion Criteria
- Patients who suffer from bladder infections (not including patients with asymptomatic bacteriuria)
- Patients who are pregnant
- Patients with recent (less than 2 weeks) pelvic floor surgery
- Patients who require the use of a suprapubic catheter
- Patients with significant cognitive deficiency that prevent the patient from giving informed consent
Data sourced from ClinicalTrials.gov (NCT03615001). 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.