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Recruiting NCT06336304

NXT Post-Market Clinical Follow-up

— Observational Urinary Incontinence Urinary Obstruction Urinary Bladder, Overactive Urinary Bladder, Neurogenic

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Urodynamic procedure.
Who it may be relevant to
Registry conditions: Urinary Incontinence, Urinary Obstruction, Urinary Bladder, Overactive, Urinary Bladder, Neurogenic. Basic parameters: No limits · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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

Detailed 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.

Interventions

  • Diagnostic test Urodynamic procedure
    Urodynamic procedure

Primary outcome measures

  • Assess NXT system performance [Time frame: 120 Minutes]
  • Assess NXT system safety [Time frame: 120 Minutes]
Secondary outcome measures (1)
  • Assess NXT system performance [Time frame: 120 Minutes]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

United States · 5 centers
  • Chesapeake Urology Hanover — Hanover
  • Chesapeake Urology Owing Mills — Owing Mills
  • Nationwide Children's Hospital — Columbus
  • Ohio State University — Columbus
  • University of Virginia — Charlottesville

Identifiers

NCT: NCT06336304 · NXTPMCF-01

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗