Vaginal Infection
Conditions
Keywords
VAGINAL INFECTION, COLOR APPEARANCE, ELEVATED Ph
Brief summary
This study was designed to validate the color appearance on the newly developed panty liner (NORMA-SENSE). The NORMA-SENSE liner changes color when worn by the user and comes into contact with vaginal secretion with an elevated pH level, without false positives due to urine remains or incontinence. The study will also asses the physical comfort in using NORMA-SENSE and the result reading clarity which includes the ability to visualize and interpret the NORMA-SENSE strip results.
Interventions
DEVICENORMA-SENSE
Should be used by the clinician. the test usage will take up to 6 hours. The result reading will take few second.
Sponsors
Carmel Medical Center
Study design
Observational model
CASE_ONLY
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 70 Years
Healthy volunteers
Yes
Inclusion criteria
1. Women, age 18 years or greater without symptoms of vaginal infection. 2. Subject is ready to sign the informed consent form.
Exclusion criteria
1. Subject is unable or unwilling to cooperate with study procedures. 2. Subject is currently participating in another clinical study. 3. Subject suffers from vaginal bleeding or is menstruating. 4. Subject that have had sexual relations within the last 12 hours. 5. Subject that applied local antiseptic or antibiotic or vaginal treatment within the last 3 days. 6. Subject that applied vaginal douching within 12 hours prior to the visit at the clinic.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| We will asses agreement between the color status of the NORMA-SENSE as reported by the subject after using the panty liner, and the pH measurement with Nitrazine paper. | 1 week |
Countries
Israel
Contacts
Primary ContactHADAR KESSARY, PhD
Outcome results
None listed