NXT Post-Market Clinical Follow-up

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

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

Study Overview

• Status: Recruiting
• Conditions: Urinary Bladder, Overactive; Urinary Incontinence; Urinary Bladder, Neurogenic; Urinary Incontinence, Urge; Urinary Obstruction
• Intervention / Treatment: Diagnostic test: Urodynamic procedure

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.

• Study Type: Observational
• Enrollment (Estimated): 180

Contacts and Locations

• Study Contact: Name: Kaitlyn Palm; Phone Number: 6128160068; Email: rs.nxtpmcf@laborie.com
• Study Contact Backup: Name: Adele Campbell; Phone Number: 6032558251; Email: rs.nxtpmcf@laborie.com

Study Locations

• United States
  • Maryland
    • Hanover, Maryland, United States, 21076
      • Recruiting
      • Chesapeake Urology Hanover
      • Principal Investigator: Kaiser Robertson, MD
      • Contact: Barbara Kyei
    • Owing Mills, Maryland, United States, 21117
      • Recruiting
      • Chesapeake Urology Owing Mills
      • Principal Investigator: Laura Giusto, MD
      • Contact: Seema Shahi
  • Ohio
    • Columbus, Ohio, United States, 43205
      • Not yet recruiting
      • Nationwide Children's Hospital
      • Contact: Myanah Keys
      • Principal Investigator: Christina Ching, MD
    • Columbus, Ohio, United States, 43212
      • Recruiting
      • Ohio State University
      • Contact: Maxwell Newton; Phone Number: 614-366-9561; Email: maxwell.newton@osumc.edu
      • Principal Investigator: Iryna Crescenze, MD
  • Virginia
    • Charlottesville, Virginia, United States, 22903
      • Recruiting
      • University of Virginia
      • Contact: Olusegun Adelaja; Phone Number: 434-924-5783; Email: oba4e@virginia.edu
      • Principal Investigator: Jacqueline Zillioux, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Male, Female and Pediatric subjects who have been medically indicated for UDS testing.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

6

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Pediatric	Diagnostic test: Urodynamic procedure; Urodynamic procedure
Male Adult Obstructive	Diagnostic test: Urodynamic procedure; Urodynamic procedure
Male Adult Incontinence and/or Overactive Bladder	Diagnostic test: Urodynamic procedure; Urodynamic procedure
Female Adult Obstructive	Diagnostic test: Urodynamic procedure; Urodynamic procedure
Female Adult Incontinence and/or Overactive Bladder	Diagnostic test: Urodynamic procedure; Urodynamic procedure
Adults with Neurological Co-morbidities	Diagnostic test: Urodynamic procedure; Urodynamic procedure

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assess NXT system performance	Assess the proportion of affirmative responses to the question: did the NXT system successfully measure all necessary urodynamic parameters you required for this patient?	120 Minutes
Assess NXT system safety	The primary safety endpoint will be measured by recording the incidence of serious adverse events and adverse events.	120 Minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assess NXT system performance	Assess the proportion of affirmative responses to the question: Was the urodynamic study completed without any technical failure that prevented its completion?	120 Minutes

Collaborators and Investigators

• Sponsor: Laborie Medical Technologies Inc.

Study record dates

Study Major Dates

• Study Start (Actual): June 18, 2024
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): March 1, 2027

Study Registration Dates

• First Submitted: March 21, 2024
• First Submitted That Met QC Criteria: March 21, 2024
• First Posted (Actual): March 28, 2024

Study Record Updates

• Last Update Posted (Actual): May 15, 2026
• Last Update Submitted That Met QC Criteria: May 13, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Neurologic Manifestations; Nervous System Diseases; Male Urogenital Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urination Disorders; Lower Urinary Tract Symptoms; Urological Manifestations; Urinary Bladder Diseases; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Urinary Incontinence; Urinary Bladder, Overactive; Urinary Bladder, Neurogenic; Urinary Incontinence, Urge
• Other Study ID Numbers: NXTPMCF-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No