NXT Post-Market Clinical Follow-up

Laborie Medical Technologies

Status

Enrolling

Conditions

Urinary Obstruction

Urinary Bladder, Overactive

Urinary Incontinence, Urge

Urinary Bladder, Neurogenic

Urinary Incontinence

Treatments

Diagnostic Test: Urodynamic procedure

Study type

Observational

Funder types

Industry

Identifiers

NCT06336304

NXTPMCF-01

Details and patient eligibility

About

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

Full description

The primary objective of this study is to confirm the safety and performance of NXT urodynamic system for the intended patient populations, medically indicated for urodynamic study.

Enrollment

180 estimated patients

Sex

All

Volunteers

No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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