EFFICACY AND SAFETY OF OVA AND LAVAGE MEDICAL DEVICES IN THE TREATMENT OF NON-SPECIFIC VULVOVAGINITIS

Launched by OSPEDALE DEL MARE · Dec 5, 2022

Keywords

ClinConnect Summary

No description provided

Gender

FEMALE

Eligibility criteria

• Inclusion criteria:
• • Signed written informed consent
• • Subjects diagnosed with vulvovaginitis
• • Presence of at least two subjective symptoms and two objective signs (at least moderate) of vaginal inflammation. Vaginal inflammation will be assessed on six subjective symptoms (burning, pain, itching, vaginal dryness, dyspareunia and dysuria and four objective signs (leucorrhoea, vulvar erythema, vulvar oedema and presence of abrasion/erosion)
• • The patient is able to read and understand the language and content of the study material, understand the requirements for follow-up visits, willing and able to provide information at scheduled assessments and willing and able to fulfil the requirements of the study
• • PAP positive patients were allocated to group D
• Exclusion Criteria:
• • Persons who do not meet the inclusion criteria
• • Patients who do not sign the informed consent form
• • Other gynaecological diseases (in addition to cervicovaginitis), immunosuppressive diseases (i.e. HIV infection) or who are immunocompromised for reasons such as corticosteroid therapy, chemotherapy, anti-angiogenic agents or immunosuppressants
• • Patients being treated with antibiotics, anti-inflammatory agents, analgesics, antineoplastic or immunosuppressive drugs within 10 days prior to inclusion in the study
• • History of connective tissue disease, e.g. systemic lupus erythematosus, systemic sclerosis, Sjogren's syndrome or mixed connective tissue disease
• • Known allergy to any component of the device
• • Subjects who are unable to understand informed consent or who have a high probability of noncompliance with study procedures and/or noncompletion of the study in the judgment of the investigator
• • Time between last day of last menstruation and baseline visit\> 16 days or ≤5 days

Trial Officials