BIOAPIGYN® VAGINAL OINTMENT FOR PELVIC MUSCLE TONUS

Projekt je sufinancirala Europska unija iz Europskog fonda za regionalni razvoj

Naziv projekta: Certifikacijom proizvoda tvrtke Apiherbal d.o.o. do tržišta

Razdoblje provedbe Projekta: od 16.srpnja 2018. do 02.studednog 2019. godine

BIOAPIGYN® VAGINAL OINTMENT FOR  PELVIC MUSCLE TONUS

Bioapigyn^Ò vaginal ointment for pelvic muscle tonus is medical device based on the ingredients of herbal and honeybees origin containing no synthetic preservatives, colorants or fragrances.

Composition: honey, Cera flava,  glycerin, oil macerate of Capsella bursa-pastoris L., oil macerate of Urtica diodica L., oil macerate of Quercus robur L., oil macerate of Salvia officinalis L., oil macerate of Achilea millefolium L.,  oil macerate of Alchemilla vulgaris L., oil macerate of Calendula officinalis L., oil macerate of Matricaria chamomilla L., oil macerate of Plantago major L oil macerate of Olea europaea L.; essential oils: Melaleuca alternifolia, Thymus vulgaris ct. Thymol, Origanum vulgare.

Intended use. Bioapigyn^Ò vaginal ointment for pelvic muscle tonus is intended to relieve the symptoms of stress, urge and mixed urinary incontinence in women older than 18 years of age, especially in menopausal/postmenopausal women, characterized by involuntary leakage of urine during effort or exertion, or upon sneezing or coughing; involuntary loss of urine preceded by a sudden and severe desire to pass urine; involuntary leakage of urine associated with the symptoms of urgency, as well as loss of urine with exertion, effort, sneezing, or coughing; nocturia; urine retention.

The device is also intended to relieve the symptoms of vulvovaginal disorders caused by an increase in vaginal pH level, characterized by vaginal discharge, vaginal dryness, dyspareunia, abnormal vaginal odour, irritation, burning, itching, and oedema in the vaginal and vulvar area.

Mode of action. Bioapigyn^Ò vaginal ointment for pelvic muscle tonus is class IIa medical device which alleviates the symptoms of incontinence due to the presence of ingredients that stimulate the contraction / relaxation of the smooth muscles of the pelvic floor, which results in their tightening and firming and consequently leads to the alleviation of all symptoms of incontinence.

The ointment is also intended to relieve the symptoms of vulvo-vaginal disorders characterized by vaginal discharge, unpleasant odor, itching, painful intercourse and edema. The ointment creates an acidic, viscous environment with low water activity that prevents the growth, adhesion and replication of pathogens and lowers the pH of the vagina to optimal values. The coating, lubricating and emollient effect of the product results in the creation of a protective layer on the damaged mucosa, which enables its recovery and prevents further irritation, alleviates vaginal dryness and painful intercourse. The combination of essential oils and herbal macerate also removes the unpleasant odor of various pathological conditions.

Instructions for use: Insert 2.5 mL of the ointment deep into the vagina using the applicator. Use before bedtime. Use continuously for 30 consecutive days. If necessary, use 2-3 times a week for the next 8 weeks. After each use, separate the applicator plunger from its body and clean the parts using warm water and a detergent. Having washed your hands, use your finger to apply a thin layer of the ointment to the external genitalia.

Precautions and storage condition: The device must not be use during the pregnancy and breast-feeding or in the case of hypersensitivity to any component of the product.  The device must be stored in dark please out of reach of children at temperature below 25 ⁰C.

Packaging: 50 mL ointment in aluminum tube, vaginal applicator (dosing pipette) and instruction for use paced in secondary carton box.

Summary of the clinical investigation results: Vaginal application of the Bioapigyn^Ò ointment for pelvic muscle tonus for 28 consecutive days (2.5 mL per day) resulted in complete disappearance of vulvo-vaginal disorders, 14.2% decrease in vaginal pH, 76.9% decrease in residual urine volume and 54.9% decrease in the mean value of ICIQ-UI-SF score. In the same time, perineometry parameters that determine pelvic floor muscle strength increased between 31.5 and 34.3%. The treatment resulted with significant improvement of the symptoms in 74.2% of the participants and cure in 25.8% of the participants.

None of the patients experienced any adverse effect (worsening of the existing symptoms, appearance of new symptoms, irritation or allergic reaction) during the treatment and follow up period.

For more information follow the links:

https://www.researchgate.net/publication/338177903_BioapigynROintment_of_Pelvic_Muscle_Tonus_Versus_Pelvic_Floor_Muscle_Training_for_the_Treatment_of_Urinary_Incontinence

https://www.researchgate.net/publication/328731602_EFFICACY_OF_BIOAPIGYN_OINTMENT_FOR_PELVIC_MUSCLE_TONUS_IN_THE_TREATMENT_OF_STRESS_URINARY_INCONTINENCE_AND_VULVOVAGNAL_DISORDERS

https://www.researchgate.net/publication/305495571_Original_Research_Paper_Commerce_Medical_Science_Development_And_Testing_of_New_Herbal_Ointment_for_the_Treatment_of_Stress_Urinary_Incontinence-A_Preliminary_Study