This is an open user study to evaluate D005 vagnial mousse with regards to user-friendliness, and measure time from start of treatment to symptom relief and measure the clarity of instructional material. The study will be conducted at seven sites in Sweden, the study population will consist of up to 100 female subjects.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
76
D005 Vaginal Mousse is class IIa medical device for treatment of Bacterial Vaginosis.
Mama Mia Väla
Väla, Helsingborg, Sweden
Mednika AB
Linköping, Sweden
Hälsomedicinskt Center
Lomma, Sweden
Mama Mia Barnmorskemottagning
Malmö, Sweden
Evaluate symptom relief during treatment with Vernivia®.
Evaluation of number of days from start of treatment until symptom relief
Time frame: 1-7 days
Self-reported grading of malodorous discharge (0-3)
Evaluate how the user experiences the product with regards to malodorous (1 = Not likely, 10 = Very likely)
Time frame: 1-7 days
Net Promotor Score regarding user-friendliness
Evaluate how the user experiences the user-friendliness (1 = Not likely, 10 = Very likely)
Time frame: 1-7 days
Clarity of the IFU (Instructions For Use)
Evaluate how the user experiences the IFU (Instructions For Use) (1= Not at all informative, 5= Very informative)
Time frame: 1-7 days
Clarity of instructional video
Evaluate how the user experiences the instructional video (1= Not at all informative, 5= Very informative)
Time frame: 1-7 days
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Kvinnohälsan Stadsfjärden
Nyköping, Sweden
2Heal Medical
Stockholm, Sweden
Ondrasek Läkarmottagning
Sundsvall, Sweden