Tetra-NIRS Clinical Study

NCT00871975 | Terminated Phase 4 Results

• 1 other identifier: C001-C0015 TETRA-NIRS
• Study Type: interventional
• Target: 155
• Locations: 3 countries
• Sites: 3

Brief Summary

The purpose of this evaluation is to validate the previous clinical study results using a Near-Infrared Spectroscopy (NIRS) device, as compared to the conventional urodynamics (UDS) testing. The experiment will use the commercially available Tetra-NIRS and Laborie UDS equipment. The hypothesis is that the Tetra-NIRS device, in the clinical environment, provides data to enhance the analysis using the standard urodynamics equipment (stand-alone Urodynamic procedure).

Conditions

Lower Urinary Tract Symptoms; Overactive Bladder

Keywords

LUTS; OAB

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Urodynamic Detrusor Overactivity Events or Prostatic Obstruction as Detected by Tetra-NIRS Compared to Urodynamics

  The Tetra-NIRS device provides a linear pattern similar to the pressures obtained during urodynamics. The NIRS output shows relative change in hemoglobin concentrations (oxygenated and deoxygenated) where the numerical value does not actually indicate the concentration, so there is no unit of measure. The numerical output is used to track change over time, or trendline analysis. A qualified interpreter studied tracings for significant changes (+/-2 Hb units) in the NIRS patterning during detrusor overactivity events. As well, under its' approved intended use, Tetra-NIRS trendline analysis was compared against urodynamics during voiding in males, such that a downward trend during voiding indicates urethral obstruction, and an upward trend indicates an unobstructed urethra.

  1 Year

Study Arms (1)

Urodynamics + Tetra

EXPERIMENTAL

All patients were recruited to the same arm and receive Urodynamics testing as part of the routine diagnostic work-up, plus the Tetra-NIRS intervention.

Device: Urodynamics + TETRA - NIRS

Interventions

Urodynamics + TETRA - NIRS DEVICE

Urodynamics will be performed as per standard of care for patients enrolled, whereby one catheter is inserted into the bladder and one in the rectum to analyze bladder filling, storage and voiding conditions via pressures measured and urine flow rates detected by a uroflowmeter. Tetra-NIRS will be concurrently performed where Tetra-NIRS unit uses near infrared light at 3 different wavelengths to measure changes in haemoglobin and cytochrome. A patch is applied externally to measure these changes in the detrusor muscle of 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 a correlation between the changes in haemoglobin and cytochrome and the pressure values obtained during urodynamics procedures.

Urodynamics + Tetra

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• The patient has an existing health condition which the investigators feel will not allow for safe or accurate measurements with the Tetra-NIRS device.

Sponsors & Collaborators

• Laborie Medical Technologies Inc.: lead

Study Sites (3)

Vanderbilt University

Nashville, Tennessee, 37232, United States

Location

Sunnybrook Health Sciences Centre

Toronto, Ontario, Canada

Location

King's College Hospital NHS Foundation Trust

London, United Kingdom

Location

Related Publications (1)

• Mastoroudes H, Giarenis I, Vella M, Srikrishna S, Robinson D, Cardozo L, Karrouze I, Campbell A, Macnab A. Use of near infrared spectroscopy as an alternative to videourodynamics to detect detrusor overactivity in women with the overactive bladder syndrome. Urology. 2012 Sep;80(3):547-50. doi: 10.1016/j.urology.2012.05.036. Epub 2012 Jul 26.

  PMID: 22840868 RESULT

MeSH Terms

Conditions

Lower Urinary Tract Symptoms; Urinary Bladder, Overactive

Condition Hierarchy (Ancestors)

Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Limitations and Caveats

Early termination was due to slow recruitment exceeding trial deadlines. Technical issues resulted in several studies being excluded (8).

Results Point of Contact

• Title: Clinical Research Administrator
• Organization: LABORIE

acampbell@laborie.com

905 612 1170

Study Officials

• Sender Herschorn, MD

  Sunnybrook Health Sciences Centre

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 26, 2009
• First Posted: March 30, 2009
• Study Start: April 1, 2009
• Primary Completion: February 1, 2012
• Study Completion: February 1, 2012
• Last Updated: July 19, 2016
• Results First Posted: July 19, 2016

Record last verified: 2016-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1); GB (1); CA (1)