T-DOC® NXT Clinical Investigation | Clinical Trial

Key information

Conditions

Incontinence, Urge Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Lower Urinary Tract Symptoms Male Urogenital Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms Urinary Incontinence Urinary Incontinence, Urge Urination Disorders Urogenital Diseases Urologic Diseases Urological Manifestations

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Franklin Square Hospital/White Marsh

Baltimore, Maryland, 21237, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Male and Female (Adult age 21+)
Patients with clinical indication for urodynamics (UDS) testing, for any medically necessary reason as per the physician.

Exclusion criteria

Patients who suffer from bladder infections (not including patients with asymptomatic bacteriuria)
Patients who are pregnant
Patients with recent (less than 2 weeks) pelvic floor surgery
Patients who require the use of a suprapubic catheter
Patients with significant cognitive deficiency that prevent the patient from giving informed consent

Treatment and study plan

TDOC NXT

Device

Assessing the Performance, Safety and Usability of our Next Generation T-DOC® NXT Catheter for Performing Urodynamic Studies

Primary outcomes

The Number of Patients in Which the T-DOC® NXT Catheters Are Safe in Measuring Urodynamic Pressure in Adults.

Time frame: 2 months

A binary clinician response after each UDS study is used to assess if it is clinically adequate (success) or inadequate (failure) in each patients questionnaire and presented to the clinician where safety (Yes the device is safe and No the device is not safe) will be reported. A minimum of 20 patient questionnaires is required to answer "YES" the device is safe for a positive outcome and a maximum of 40.
The Number of Patients in Which the T-DOC® NXT Catheters Are Effective in Measuring Urodynamic Pressure in Adults.

Time frame: 2 months

A binary clinician response after each UDS study is used to assess if it is clinically adequate (success) or inadequate (failure) in each patients questionnaire and presented to the clinician where effectiveness (Yes the device is effective and No the device is not effective) will be reported. A minimum of 20 patient questionnaires is required to answer "YES" the device is effective for a positive outcome and a maximum of 40.

Sponsors and collaborators

Lead sponsor

Laborie Medical Technologies Inc.

Industry

Registry information

Official study title

Assessing the Performance, Safety and Usability of Our Next Generation T-DOC® NXT Catheter for Performing Urodynamic Studies

Important dates

Study start: 2018
Primary completion: 2018
Study completion: 2018
First posted: Aug 3, 2018
Registry last updated: Jun 9, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed