Urinary IncontinenceNCT06336304
NXT Post-Market Clinical Follow-up
An observational study of Urinary Incontinence and Urinary Obstruction, run by Laborie Medical Technologies Inc. at 5 sites in United States.
Trial summary
NXT Urodynamics System Post-Market Clinical Follow-up Clinical Investigation to Confirm Ongoing Safety and Performance in Urodynamic Patient Sub-Populations Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Urinary Incontinence, Urinary Obstruction, Urinary Bladder, Overactive
- What is being tested?
- Urodynamic procedure
- How many people
- 163 participants
- Where
- 5 sitesUnited States
- Study dates
- 18 Jun 2024to 30 Jun 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Male, Female and Pediatric subjects who have been medically indicated for UDS testing.
Who may be able to join
- Patients medically indicated for urodynamic study
- Patient or legally authorized representative provides written authorization and/or consent per institution and geographical requirements
Who cannot join
- 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
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
University of Virginia
Charlottesville, Virginia, 22903
Nationwide Children's Hospital
Columbus, Ohio, 43205
Ohio State University
Columbus, Ohio, 43212
Chesapeake Urology Hanover
Hanover, Maryland, 21076
Chesapeake Urology Owing Mills
Owing Mills, Maryland, 21117
About this study
Official title: 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
Read the 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.
- Conditions
- Urinary Incontinence, Urinary Obstruction, Urinary Bladder, Overactive, Urinary Bladder, Neurogenic, Urinary Incontinence, Urge
- Being tested
- Urodynamic procedure
- Medical subject headings
- Urinary Incontinence, Urinary Bladder, Overactive, Urinary Bladder, Neurogenic, Urinary Incontinence, Urge
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Urodynamic procedureDiagnostic test
Urodynamic procedure
| Study group | Role | What they receive |
|---|---|---|
| Pediatric | Not described Receives: Diagnostic Test: Urodynamic procedure | |
| Male Adult Obstructive | Not described | |
| Male Adult Incontinence and/or Overactive Bladder | Not described Receives: Diagnostic Test: Urodynamic procedure | |
| Female Adult Obstructive | Not described | |
| Female Adult Incontinence and/or Overactive Bladder | Not described Receives: Diagnostic Test: Urodynamic procedure | |
| Adults with Neurological Co-morbidities | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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?
Measured: 120 Minutes
Assess NXT system safety
The primary safety endpoint will be measured by recording the incidence of serious adverse events and adverse events.
Measured: 120 Minutes
Secondary outcomes (1)
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?
Measured: 120 Minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2024
- Study start18 Jun 2024
- Primary completion30 Jun 2026
- Study completion30 Jun 2026
Why it stopped: Business decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urinary IncontinenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 163 participants (actual)
Sponsor and investigators
- Lead sponsor
- Laborie Medical Technologies Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06336304
- Sponsor's protocol ID
- NXTPMCF-01
- Status last verified
- Aug 2026
- First submitted
- 21 Mar 2024
- Last updated
- 31 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- NXT Urodynamics System Post-Market Clinical Follow-up Clinical Investigation
- ClinicalTrials.gov ID
- NCT06336304
- Acronym / sponsor ID
- NXTPMCF-01
- Conditions
- Urinary Incontinence, Urinary Obstruction, Urinary Bladder, Overactive, Urinary Bladder, Neurogenic, Urinary Incontinence, Urge
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Business decision
- Enrolment
- 163 participants (actual)
- Lead sponsor
- Laborie Medical Technologies Inc.Industry (pharma, biotech, devices)
- Study start
- 18 Jun 2024 (actual)
- Primary completion
- 30 Jun 2026 (actual)
- Study completion
- 30 Jun 2026 (actual)
- First posted
- 28 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Pediatric | – | Diagnostic Test: Urodynamic procedure |
| Male Adult Obstructive | – | – |
| Male Adult Incontinence and/or Overactive Bladder | – | Diagnostic Test: Urodynamic procedure |
| Female Adult Obstructive | – | – |
| Female Adult Incontinence and/or Overactive Bladder | – | Diagnostic Test: Urodynamic procedure |
| Adults with Neurological Co-morbidities | – | – |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Male, Female and Pediatric subjects who have been medically indicated for UDS testing.
Key inclusion criteria (2 listed)
- Patients medically indicated for urodynamic study
- Patient or legally authorized representative provides written authorization and/or consent per institution and geographical requirements
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Urodynamic procedureUrodynamic procedure | Diagnostic test | Female Adult Incontinence and/or Overactive Bladder, Male Adult Incontinence and/or Overactive Bladder, Pediatric |
Primary outcome
Assess NXT system performance
Time frame: 120 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 safety
Time frame: 120 Minutes
The primary safety endpoint will be measured by recording the incidence of serious adverse events and adverse events.
1 secondary outcome
Assess NXT system performance
Time frame: 120 Minutes
Results and safety
The study was stopped early (reason given: Business decision). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Urinary Incontinence and Urinary Obstruction, run by Laborie Medical Technologies Inc. at 5 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 31 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Business decision). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assess NXT system performance (time frame: 120 Minutes). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Aug 2026.