N/A N=42 Diagnostic

Uro-NIRS Clinical Study

Lower Urinary Tract Symptoms · Overactive Bladder

Bottom Line

View on ClinicalTrials.gov: NCT00706407 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Mar 2018

Primary outcome: Primary: Number of Participants Reporting Downward/Flat/Upward Patterns as Assessed by Near Infrared Spectroscopy (NIRS) for BOO Diagnosis — 9; 4; 13; 4 participants

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Fully integrated Uro-NIRS:UDS (Device)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Weill Medical College of Cornell University
Primary completion: May 2010

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Participants Reporting Downward/Flat/Upward Patterns as Assessed by Near Infrared Spectroscopy (NIRS) for BOO Diagnosis	9; 4; 13; 4; 1; 5	—

Summary

The purpose of this experiment is to confirm the results of previous testing of Urodynamix's Uro-NIRS device. Together Urodynamix and Laborie have created a device that includes standard Laborie medical equipment and the experimental Urodynamix device. Collectively this integrated device is considered an investigational device, and the results from this study may be used to support a submission to the US Food and Drug Administration for the approval of the integrated device. This research is being done because we want to test the ability of the integrated Laborie and Urodynamix device to provide a non-invasive method to provide additional information to assist with the diagnosis of or treatment plan of patients suffering from urinary problems. The current technologies rely solely on the measurement of internal pressures of the bladder, which involves the insertion of catheter into the subject's urethra.

Eligibility Criteria

Inclusion 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 enrollment.

Exclusion Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00706407). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.