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INTRODUCTION AND HYPOTHESIS: This report aims to prospectively describe the effectiveness and safety of injected cross-linked hyaluronic acid (HA) for the treatment of chronic vulvar fissures. METHODS: A descriptive prospective case series design including 15 patients affected by chronic vulvar fissures who were treated with cross-linked HA filler between December 2020 and July 2021. The validated 21-item Vulvovaginal Symptoms Questionnaire (VSQ) was used to evaluate the results from baseline up to 9 months after the HA infiltration. RESULTS: A total of 15 patients suffering from chronic vulvar fissures were treated with an injection of 19 mg/mL HA filler. We found a significant improvement in VSQ scores at the end of the treatment compared to baseline. Patients reported excellent tolerance of the procedure, and no complications were recorded. CONCLUSIONS: Cross-linked HA infiltration of the vulvar vestibule and posterior vaginal wall appeared to be a promising approach for chronic vulvar fissures.
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Ácido Hialurônico , Vulva , Feminino , Humanos , Vagina , InjeçõesRESUMO
It is becoming increasingly common that patients' preferences move towards non-surgical approaches, such as pulsed magnetic stimulation, for female stress urinary incontinence. OBJECTIVE: We evaluated the efficacy and safety of a device that uses electromagnetic technology to treat urinary incontinence, with an emphasis on health-related quality of life. METHODS: A total of 47 female subjects from 18 to 80 years old were enrolled. After block randomization, treatment consisted of 2 pulsed planar magnetic stimulation sessions per week for 4 weeks (8 sessions). Validated questionnaires: Female Sexual Function Index, International Consultation on Incontinence Questionnaire for Urinary Incontinence: Short Form, and Pelvic Floor Bothersome. Follow-ups were performed at weeks 1, 9, and 14. RESULTS: The present study is one of the first clinical trials published evaluating the efficacy and safety of the electromagnetism-based device with flat configuration in patients with stress urinary incontinence, showing a reduction in PFBQ, ICQSF, and Oxford test scores during follow-up, and significantly at week 14 of follow-up, which implied a favorable impact on clinical outcomes, quality of life, and sexuality. CONCLUSIONS: The improved results in the treatment group compared with the simulated group show that pulsed magnetic stimulation is a safe and attractive non-invasive alternative for patients who prefer non-surgical treatments.
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Incontinência Urinária por Estresse , Incontinência Urinária , Humanos , Feminino , Adolescente , Adulto Jovem , Adulto , Pessoa de Meia-Idade , Idoso , Idoso de 80 Anos ou mais , Incontinência Urinária por Estresse/terapia , Qualidade de Vida , Sexualidade , Fenômenos Magnéticos , Resultado do TratamentoRESUMO
To alert patients and health care providers about the use of energy-based devices to perform a vaginal "rejuvenation," cosmetic vaginal procedures, or nonsurgical vaginal procedures to treat symptoms related to menopause, urinary incontinence, or sexual function, the US Food and Drug Administration (FDA) has issued a warning about the effectiveness and safety of such devices. We agree with the FDA that certain devices (laser, radiofrequency, etc.) have been marketed inappropriately for uses that are outside of their cleared or approved intended uses. We want to position ourselves in the strict training of professionals so that the indications and techniques are used in the best possible way, knowing that, similar to any medical or surgical technique, the side effects can appear in the short and long term, and should be recognized and remedied.
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Ginecologia , Fototerapia , United States Food and Drug Administration , Humanos , Terapia a Laser , Guias de Prática Clínica como Assunto , Terapia por Radiofrequência , Estados UnidosRESUMO
INTRODUCTION AND HYPOTHESIS: The aim of this study was to evaluate the long-term effect of thermoablative fractional CO2 laser (TACO2L) as an alternative treatment for early stages of stress urinary incontinence (SUI) in postmenopausal women with genitourinary syndrome of menopause. METHODS: A total of 161 postmenopausal patients (age 53.38 ± 5.1 years, range 45-65 years) with a clinical diagnosis of mild SUI were prospectively enrolled in the study. Patients received one treatment with TACO2L every 30-45 days, each treatment comprising four sessions, followed in all patients by a yearly treatment session at 12, 24 and 36 months. SUI was evaluated using the International Continence Society 1-h pad test and the International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI SF) before and after TACO2L treatment. RESULTS: TACO2L treatment was associated with a significant improvement in ICIQ-UI SF scores and 1-h pad weight test at 12 months (both p < 0.001), 24 months (both p < 0.001) and 36 months (both p < 0.001). Improvements were maintained for up to 36 months without the need for any further intervention. The results were confirmed by significant histological changes related to trophic restoration of the vagina, responsible for extrinsic and intrinsic mechanisms involved in urinary continence. CONCLUSIONS: Our results suggest that TACO2L is an efficient and safe novel treatment strategy in patients with mild SUI. Further investigation to confirm the long-term results presented here is still warranted.
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Terapia a Laser/métodos , Lasers de Gás/uso terapêutico , Menopausa , Incontinência Urinária/cirurgia , Idoso , Feminino , Humanos , Pessoa de Meia-Idade , Estudos Prospectivos , Síndrome , Resultado do Tratamento , Vagina/cirurgiaRESUMO
OBJECTIVE: Neauvia Stimulate is biocompatible, injectable hyaluronic acid (HA) filler (26 mg/ml) PEG cross-linked with 1% of calcium hydroxyapatite (CaHA) for facial soft-tissue augmentation that provides volume to tissues, followed by process of neocollagenesis for improving skin quality. AIM: The aim of the present study is to evaluate the biosafety of the product (Lot. 160517-26-1/2 PEG) on human keratinocytes cultured in vitro. MATERIAL AND METHODS: The experimental model proposed, despite being an in vitro system, allows the derivation of useful information to predict the possible activity of the product in further in vivo application. Human keratinocytes (HaCaT cells) were treated with the product for 24h at increasing concentrations of product respect to control (untreated cells). RESULTS: The biosafety of the product to be tested has been evaluated performing different methods: MTT test, NRU test, Kenacid Blue assay. Moreover, any possible effect on the structure, morphology, and viability of cells has been evaluated. CONCLUSION: In conclusion, the results obtained by the different methods show that the product Neauvia Stimulate® does not cause any cytotoxic effect and does not affect the correct structure and morphology of cells cultures.
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OBJECTIVE: To describe the benefits and safety of using Carbon Dioxide Laser in multi-pulse modalities when performing labiaplasty and anatomical variants approach for functional and cosmetic indications. DESIGN: This is a prospective, descriptive case series study. SETTING: Private Practice Quirofano Calculaser Megacentro Pinares Pereira Colombia. POPULATION: One Hundred and twelve women seeking labia minora labiaplasty for functional and cosmetic reasons were enrolled in the study protocol from June 2013 to June 2016. Labia minora labioplasty and anatomical variants approach were performed with Carbon Dioxide laser Multi-pulse modalities DEKA M.EL.A Florence Italy. MAIN OUTCOME MEASURES: Good Cosmetic results, functional and sexuality improvement. RESULTS: Dramatic changes in the VAS and VSQ were detected after the surgical procedure. All the participants reported a high degree of satisfaction, felt more confident with their partners during sexual encounters, and the procedure was well tolerated. CONCLUSION: Laser Carbon Dioxide Laser with a new pulse profile and shape seems to be a safe and precise surgical tool to perform this type of procedures, optimal biophysical and bio stimulative laser-tissue interactions allow delicate vulvar tissues to shorten downtime.