N/A
Completed N=20
T-DOC® NXT Clinical Investigation
Incontinence, Urge
Source: ClinicalTrials.gov NCT03615001 ↗
Enrolled (actual)
20
Serious AEs
0.0%
Results posted
Jun 2020
Primary outcomePrimary: The Number of Patients in Which the T-DOC® NXT Catheters Are Safe in Measuring Urodynamic Pressure in Adults. — 20 Participants
Summary
Assessing the Performance, Safety and Usability of our Next Generation T-DOC® NXT Catheter for Performing Urodynamic Studies
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 | — |
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. Informational only — not medical advice.