N/A
Completed N=42
Uro-NIRS Clinical Study
Source: ClinicalTrials.gov NCT00706407 ↗Enrolled (actual)
42
Serious AEs
0.0%
Results posted
Mar 2018
Primary outcomePrimary: Number of Participants Reporting Downward/Flat/Upward Patterns as Assessed by Near Infrared Spectroscopy (NIRS) for BOO Diagnosis — 9; 4; 13; 4 participants
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.
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 | — |
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.
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. Informational only — not medical advice.