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Diagnostic Utility of Tetra-NIRS in Conjunction With Urodynamic Studies

This study has been terminated.
(Low enrollment exceeding trial deadlines)
Sponsor:
Information provided by (Responsible Party):
Laborie Medical Technologies Inc.
ClinicalTrials.gov Identifier:
NCT00871975
First received: March 26, 2009
Last updated: May 16, 2012
Last verified: May 2012
  Purpose

The purpose of this evaluation is to validate the previous clinical study results using the Tetra-NIRS as compared to the conventional UDS in the voiding procedure. The experiment will use a commercially available Tetra-NIRS device.

The hypothesis is that the commercially available Tetra-NIRS device, in the clinical environment, provides data to enhance the analysis using the standard urodynamics equipment (stand-alone Urodynamix procedure).


Condition Intervention Phase
Lower Urinary Tract Symptoms
Overactive Bladder
Device: TETRA - NIRS
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: The Purpose of This Experiment is to Validate the Previous Clinical Study Results Using the Tetra-NIRS as Compared to the Conventional UDS in the Voiding Procedure. This Evaluation Will Use a Commercially Available Tetra-NIRS Device.

Resource links provided by NLM:


Further study details as provided by Laborie Medical Technologies Inc.:

Primary Outcome Measures:
  • The hypothesis is that the commercially available Tetra-NIRS device, in the clinical environment, provides data to enhance the analysis using the standard urodynamics equipment (stand-alone UDS). [ Time Frame: 1 Year ] [ Designated as safety issue: No ]

Enrollment: 154
Study Start Date: April 2009
Study Completion Date: February 2012
Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: TETRA - NIRS
    The Tetra-NIRS unit uses near infrared light at 3 different wavelengths to measure changes in haemoglobin and cytochrome from the detrusor muscle from the human bladder wall. This process is similar to what is used for cerebral and muscle oxygenation monitoring (e.g., pulse oximetry). Previous clinical feasibility studies have identified the correlation between the changes in haemoglobin and cytochrome and the pressure values obtained during urodynamics procedures and uroflow procedures.
Detailed Description:

This is a study of the commercially available Tetra-NIRS device to confirm the results collected using the commercially available Tetra-NIRS device. The study will evaluate male patients with lower urinary tract symptoms (LUTS). The study will also include and evaluate female subjects with over-active bladder (OAB).

The Tetra-NIRS unit uses near infrared light at 3 different wavelengths to measure changes in haemoglobin and cytochrome from the detrusor muscle from the human bladder wall. This process is similar to what is used for cerebral and muscle oxygenation monitoring (e.g., pulse oximetry). Previous clinical feasibility studies have identified the correlation between the changes in haemoglobin and cytochrome and the pressure values obtained during urodynamics procedures and uroflow procedures.

For this study the Tetra-NIRS results specifically will not be used by the urologist/nurse to guide in patient management and treatment decisions, but rather will only be used to collect measurements from the patient. The Tetra-NIRS sensor patch will be adhered to skin surface where their bladder is located.

For this reproducibility study a minimum of 30 male subjects with LUTS scheduled to undergo a urodynamics procedure are to be enrolled. Up to 20 female subjects with OAB will be enrolled. The investigators will attempt to equally enrol male subjects into each of the two categories including obstructed and non-obstructed groups (equivocal subjects will be determined by the investigator). Refer to Appendix A for additional information on sample size justification.

The investigators should seek to enroll a minimum of 10% of the subjects with a Body Mass Index (BMI) > 30, where BMI is calculated:

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • The selection of subjects enrolled for testing must meet the following criteria:

    • Subjects must be 18 years of age or older.
    • Subjects are patients of one of the institutions and are currently scheduled for UDS
    • Male subjects must have LUTS
    • Female subjects must have OAB
    • Subjects must give their informed consent prior to enrolment.

Exclusion Criteria:

  • The patient has an existing health condition which the investigators feel will not allow for safe or accurate measurements with the Tetra-NIRS device.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00871975

Locations
United States, Tennessee
Vanderbilt University
Nashville, Tennessee, United States
Canada, Ontario
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada
United Kingdom
King's College Hospital NHS Foundation Trust
London, United Kingdom
Sponsors and Collaborators
Laborie Medical Technologies Inc.
Investigators
Principal Investigator: Sender Herschorn, MD Sunnybrook Health Sciences Centre
  More Information

No publications provided

Responsible Party: Laborie Medical Technologies Inc.
ClinicalTrials.gov Identifier: NCT00871975     History of Changes
Obsolete Identifiers: NCT00849225
Other Study ID Numbers: C001-C0015 TETRA-NIRS
Study First Received: March 26, 2009
Last Updated: May 16, 2012
Health Authority: United States: Institutional Review Board
Canada: Health Canada
United Kingdom: Research Ethics Committee

Keywords provided by Laborie Medical Technologies Inc.:
LUTS
OAB

Additional relevant MeSH terms:
Lower Urinary Tract Symptoms
Urinary Bladder, Overactive
Signs and Symptoms
Urinary Bladder Diseases
Urologic Diseases
Urological Manifestations

ClinicalTrials.gov processed this record on November 25, 2014