ABSTRACT
OBJECTIVE: This is a pilot study to evaluate the effectiveness of the treatment with Vaginal Soft gels technology in the improvement of common signs and symptoms in postmenopausal, postpartum and with recurrent vulvovaginitis patients. These conditions may cause the onset of Vulvovaginal Atrophy (VVA) with effects on sexual activity, self-confidence and daily activities. The main symptoms are itching, irritation and dryness. Many therapies have been evaluated and almost all those without hormonal component have shown poor results. PATIENTS AND METHODS: Women diagnosed with severe VVA from January to September 2018 were recruited. The study groups were composed of 25 postmenopausal women, 30 post-partum women and 30 women with recurrent vulvovaginitis. For each group, patients were randomized 1:1 among those who carried out the experimental treatment and those that did not perform it. The efficacy of treatment was evaluated with a clinical visit in which Vaginal Health Index (VHI) was estimated. The symptomatology was determined through the questionnaire Female Sexual Function Index (FSFI). RESULTS: A significant improvement has been shown with regard to the sexual function (orgasm, lubrification, pain) in patients who performed the treatment. A significant increase in VHI has been evaluated in postmenopausal patients (4 months p=0.054, 6 months p=0.005) and in recurrent vulvovaginitis but not in post-partum patients (4 months p=0.681, 6 months p=0.109). An improvement of lubrication, satisfaction, orgasm, pain, as well as dyspareunia, was observed in the three study groups. CONCLUSIONS: In this pilot study the treatment with soft gels seems to be effective in improving sexual health and atrophy being a treatment available for all types of patients thanks to the absence of systemic and local side effects. It is an excellent alternative especially for patients who cannot use hormones. These findings must be confirmed by larger and randomized further studies.
Subject(s)
Atrophic Vaginitis/prevention & control , Vaginal Creams, Foams, and Jellies/administration & dosage , Vulvovaginitis/drug therapy , Vulvovaginitis/psychology , Adult , Atrophic Vaginitis/psychology , Equipment Design , Female , Humans , Middle Aged , Pilot Projects , Postmenopause , Postpartum Period , Random Allocation , Treatment Outcome , Vaginal Creams, Foams, and Jellies/chemistry , Vulvovaginitis/complications , Young AdultABSTRACT
El síndrome genitourinario de la menopausia (SGM) se definió para sustituir al término "atrofia vulvovaginal" como el conjunto de signos y síntomas genitourinarios asociados a la disminución de estrógenos. La primera línea de tratamiento para las manifestaciones vaginales del SGM son los hidratantes (evidencia IA) y lubricantes vaginales (evidencia IIB). Cuando estas medidas no son suficientes, o en casos moderados o intensos, el tratamiento de elección son los estrógenos locales (evidencia IA). Si coexisten síntomas vasomotores que afectan la calidad de vida, la indicación es el tratamiento hormonal sistémico (evidencia IA). Actualmente, se dispone de ospemifeno (evidencia IA), un modulador selectivo de los receptores vaginales de estrógenos (SERM), aprobado en Europa para el tratamiento de los síntomas moderados o graves en mujeres postmenopáusicas que no cumplen los requisitos para recibir estrógenos vaginales. Otros posibles tratamientos del SGM son el láser y la radiofrecuencia. No hay evidencia para indicar el uso de terapias alternativas y complementarias
Genitourinary syndrome of menopause (GSM) was defined to substitute the term "vaginal atrophy" as the signs and symptoms related to reduced circulating oestrogen levels. Vaginal moisturizers (evidence IA) and vaginal lubricants (evidence IIB) are the first-line treatments. If these measures are unsatisfactory, the choice treatment is local oestrogen therapy (evidence IA). In patients with vasomotor symptoms that impair quality of life, systemic hormone replacement therapy (evidence IA) is administered. Currently, a new therapy is available: ospemifene, a selective oestrogen receptor modulator that acts at vaginal level. It is approved in Europe for the treatment of moderate to severe symptoms in postmenopausal women who are not candidate to local oestrogen therapy. Ospemifene improves vaginal histology and physiology, and it has been safe and well tolerated both in clinical trials and in post-marketing surveillance studies. Other therapies for GSM are laser therapy and radiofrequency. Alternative therapies are not recommended
Subject(s)
Humans , Female , Atrophic Vaginitis/prevention & control , Lubricants/therapeutic use , Estrogens/administration & dosage , Wetting Agents/administration & dosage , Menopause , Female Urogenital Diseases/prevention & control , Practice Patterns, Physicians' , Estrogen Replacement TherapyABSTRACT
La atrofia vaginal, causada por el déficit estrogénico, es responsable de la aparición de síntomas que afectan la calidad de vida. El tratamiento tendrá como objetivo restaurar la fisiología urogenital y aliviar los síntomas. Para síntomas como la sequedad vaginal o la dispareunia asociada con atrofia vaginal, la primera línea de tratamiento son los hidratantes (evidencia IA) y lubricantes vaginales (evidencia IIB). Si no proporcionan una adecuada mejora de los síntomas o ante síntomas moderados-intensos, se utilizarán estrógenos. Los estrógenos son los tratamientos más efectivos. En casos de solo atrofia vaginal, la elección será la terapia con estrógenos locales (TEL) (evidencia IA). En casos que coexistan con sintomatología vasomotora que afecte a la calidad de vida, la elección será la terapia hormonal sistémica (evidencia IA). Las dosis bajas de estrógenos son el tratamiento farmacológico hormonal de primera línea para la vaginitis atrófica (AU)
Vaginal atrophy, caused by estrogen deficiency, leads to the development of symptoms that affect quality of life. Treatment aims to restore the urogenital physiology and relieve symptoms. For symptoms such as vaginal dryness or dyspareunia associated with vaginal atrophy, the first line treatments are moisturizers (Evidence IA) and vaginal lubricants (Evidence IIB). If these treatments fail to provide sufficient improvement in symptoms or when the symptoms are moderate-to-intense, estrogen can be used. Estrogens are the most effective treatments. In patients with vaginal atrophy alone, the choice is local estrogen therapy (Evidence IA). In patients who also have vasomotor symptoms affecting quality of life, treatment consists of systemic hormone replacement therapy (Evidence IA). Low dose oestrogens are a first line pharmacological treatment for atrophic vaginitis (AU)
