T-DOC® NXT Clinical Investigation

Laborie Medical Technologies

Status: Completed

Conditions: Incontinence, Urge

Treatments: Device: TDOC NXT

Study type: Interventional

Funder types: Industry

Identifiers

NCT03615001

TDOC-NXT-01

Details and patient eligibility

About

Assessing the Performance, Safety and Usability of our Next Generation T-DOC® NXT Catheter for Performing Urodynamic Studies

Enrollment: 20 patients

Sex: All

Ages: 21+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

Urodynamics Arm

Experimental group

Treatment:

Device: TDOC NXT