Diagnostic Utility of Tetra-NIRS in Conjunction With Urodynamic Studies

Overactive Bladder Clinical Trial

Official title:

The Purpose of This Experiment is to Validate the Previous Clinical Study Results Using the Tetra-NIRS (Near Infrared Spectroscopy) as Compared to the Conventional UDS in the Voiding Procedure. This Evaluation Will Use a Commercially Available Tetra-NIRS Device.

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00871975
• Other study ID #: C001-C0015 TETRA-NIRS
• Status: Terminated
• Phase: Phase 4
• First received: March 26, 2009
• Last updated: August 31, 2015
• Start date: April 2009
• Est. completion date: February 2012

Study information

• Verified date: April 2015
• Source: Laborie Medical Technologies Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardCanada: Health CanadaUnited Kingdom: Research Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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 Urodynamic procedure).

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:

Other known NCT identifiers

• NCT00849225

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 155
• Est. completion date: February 2012
• Est. primary completion date: February 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Lower Urinary Tract Symptoms
• Overactive Bladder
• Urinary Bladder, Overactive

Intervention

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.

Locations

Country	Name	City	State
Canada	Sunnybrook Health Sciences Centre	Toronto	Ontario
United Kingdom	King's College Hospital NHS Foundation Trust	London
United States	Vanderbilt University	Nashville	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
Laborie Medical Technologies Inc.

Countries where clinical trial is conducted

United States,  Canada,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The commercially available Tetra-NIRS device, in the clinical environment, provides data to enhance the analysis using the standard urodynamics equipment (stand-alone UDS).		1 Year	No