RecruitingNCT06336304

NXT Post-Market Clinical Follow-up

NXT Urodynamics System Post-Market Clinical Follow-up Clinical Investigation

Sponsor

Laborie Medical Technologies Inc.

Enrollment

180 participants

Start Date

Jun 18, 2024

Study Type

OBSERVATIONAL

Conditions

Urinary Incontinence Urinary Bladder, Neurogenic Urinary Bladder, Overactive Urinary Incontinence, Urge Urinary Obstruction

Summary

NXT Urodynamics System Post-Market Clinical Follow-up Clinical Investigation to Confirm Ongoing Safety and Performance in Urodynamic Patient Sub-Populations

Eligibility

Inclusion Criteria2

Patients medically indicated for urodynamic study
Patient or legally authorized representative provides written authorization and/or consent per institution and geographical requirements

Exclusion Criteria5

Patients or legally authorized representative with cognitive or psychiatric condition that interferes with or precludes direct and accurate communication regarding the study, giving informed consent or ability to complete the patient questionnaire
Patients with confirmed active bladder infections (not including patients with asymptotic bacteria)
Pregnant women
Patients with recent (less than 2 weeks) pelvic floor surgery
Requires use of suprapubic catheter

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