Tetra-NIRS Clinical Study

PHASE4TerminatedINTERVENTIONAL
Enrollment

155

Participants

Timeline

Start Date

April 30, 2009

Primary Completion Date

February 29, 2012

Study Completion Date

February 29, 2012

Conditions
Lower Urinary Tract SymptomsOveractive Bladder
Interventions
DEVICE

Urodynamics + TETRA - NIRS

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.

Trial Locations (3)

37232

Vanderbilt University, Nashville

Unknown

Sunnybrook Health Sciences Centre, Toronto

King's College Hospital NHS Foundation Trust, London

All Listed Sponsors
lead

Laborie Medical Technologies Inc.

INDUSTRY