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NXT Urodynamics System Post-Market Clinical Follow-up for Urinary Conditions

This study is observing the NXT Urodynamics System, a diagnostic test, to confirm its safety and how well it performs for people with urinary incontinence, overactive bladder, neurogenic bladder, or urinary obstruction. You might be able to join if you need a urodynamic study (a test that looks at how your bladder and urethra are working). The study will assess the system's performance and safety over 120 minutes. The study is currently unclear on its recruitment status and plans to enroll 180 participants.

Study design
This is an observational study, meaning researchers will watch and collect information without providing a specific treatment. It aims to enroll 180 participants.
What's involved
You would undergo a urodynamic procedure as part of your medical care. The study will assess the system's performance and safety during this procedure, which is measured at 120 minutes.
Compensation
Not stated in the trial record.
Follow-up
The primary assessments for safety and performance are measured at 120 minutes.

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NCT06336304

NXT Post-Market Clinical Follow-up

Recruiting
Not specifiedAll AgesObservational
Laborie Medical Technologies Inc.
~180 participants
Updated 2026-05-15 on ClinicalTrials.gov
What's tested:Urodynamic procedure

At a glance

Recruiting sites
4 of 5 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Assess NXT system performance
Measured over 120 Minutes
+1 more outcome measured

Conditions

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

Explore related trials

Neurogenic BladderOveractive BladderUrge incontinence of urineUrinary Tract Obstruction

Where it's being run

5 sites across 3 states
Maryland2
Ohio2
Virginia1

Who to contact

Kaitlyn Palm
[email protected]
6128160068
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

Exclusion

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

What this trial measures

  • Assess NXT system performance120 Minutes

    Assess the proportion of affirmative responses to the question: did the NXT system successfully measure all necessary urodynamic parameters you required for this patient?

  • Assess NXT system safety120 Minutes

    The primary safety endpoint will be measured by recording the incidence of serious adverse events and adverse events.