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Randomized Controlled Trial
. 2025 Oct:201:108687.
doi: 10.1016/j.maturitas.2025.108687. Epub 2025 Aug 5.

VSports最新版本 - Hyaluronic acid injection to treat symptoms of vulvovaginal atrophy and improve sexual function in postmenopausal women: A 52-week long-term follow-up

Hichem Bensmail  1 , Fabienne Marchand Lamiraud  2 , Carine Martin  3 , Sofie Pelckmans  4 , Firas Cha'ban  5 , Aliette Siboni Frisch  6 , Gulcan Deniz  7 , Pascale Sabban Serfati  8 , Brigitte Caubo  9 , Brice Gurriet  10 , Isabelle Petit Breuilh  11 , Ann Inge Pastijn  12 , Nicolas Berreni  13 , Michel Cosson  14
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Free article
Randomized Controlled Trial

Hyaluronic acid injection to treat symptoms of vulvovaginal atrophy and improve sexual function in postmenopausal women: A 52-week long-term follow-up

Hichem Bensmail et al. Maturitas. 2025 Oct.
Free article

Abstract

Objectives: To evaluate the long-term efficacy and safety of a single injection session of cross-linked hyaluronic acid for postmenopausal vulvovaginal atrophy VSports手机版. .

Study design: 12-week, randomised, placebo-controlled, single-blind phase followed by 40-week open-label phase. At study start, patients received hyaluronic acid or placebo injection. At 12 weeks, patients who initially received placebo received hyaluronic acid V体育安卓版. .

Main outcome measures: Mean change from baseline in the severity score of the most bothersome symptom, scores for vulvovaginal atrophy individual symptoms, score on the Female Sexual Function Index and vaginal pH after hyaluronic acid injection V体育ios版. Patients receiving hyaluronic acid were followed to 36 weeks or 52 weeks if treated at study start. .

Results: 115 patients receiving hyaluronic acid were analysed. The mean score for most bothersome symptom and all individual symptom scores were significantly reduced from baseline at all time points (p < 0. 001). The initial decrease in most bothersome symptom was observed at 4 weeks, with a mean (SD) decrease of -1. 05 (1. 05) to 1. 69 (1. 11), and maintained up to 52 weeks. Mean full-scale score on the Female Sexual Function Index was significantly increased from baseline at all time points (p < 0. 001). The initial increase was observed at 4 weeks, with a mean increase of 4. 50 (6. 51) to 20. 54 (8. 60), and maintained up to 52 weeks. Improvement was observed across all domains of the Female Sexual Function Index. There was a general trend for improvement in vaginal pH. VSports最新版本.

Conclusions: A single injection session of hyaluronic acid is effective in reducing vulvovaginal symptomatology and in improving sexual function for up to 52 weeks, making it a suitable management option for moderate to severe vulvovaginal atrophy symptoms V体育平台登录. .

Clinical trials: gov identifier NCT04219722. VSports注册入口.

Keywords: Dyspareunia; Genitourinary syndrome of menopause (GSM); Hyaluronic acid; Menopause; Vaginal dryness; Vulvovaginal atrophy (VVA). V体育官网入口.

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VSports在线直播 - Conflict of interest statement

Declaration of competing interest All authors were study investigators with contracts either directly (for HB, FML, SP, FC, ASF, GD, PSS, BC, BG, IPB, AIP and NB) or through their institution (for CM and MC) for participation in the study. These contracts included fees for patient recruitment and follow-up, as well as the provision of study products and materials. FML has a consulting contract with Laboratoires VIVACY for reviewing clinical evaluation documentation and physician injection training and received honoraria from Laboratoires VIVACY for symposium presentations. HB received honoraria from Laboratoires VIVACY for symposium presentation. SP had a contract with Laboratoires VIVACY for physician injection training related to this study and a consulting contract for symposium presentation. GD had a contract with Laboratoires VIVACY for physician injection training related to this study. PSS received honoraria from Laboratoires VIVACY for symposium presentations, article writing and patient promotion and interviews, as well as support from Laboratoires VIVACY for travel for a free lecture at IMCAS Asia 2024 congress. BG received payments from DISTRILASER for workshop participation and from HENNER for an online course, as well as support for attending the Société de Chirurgie Gynécologique et Pelvienne (SCGP) congress as a speaker. CM received honoraria from Laboratoires VIVACY and Laboratoires MAJORELLE for symposium presentations. MC had a contract with Laboratoires VIVACY for coordinator activities in this study. MC participated to a clinical study by AB MEDICA and by PROMEDON through a contract with his institution. MC received honoraria and had also a contract through its institution with PROVEDAY for coordinator activities in a clinical study. Additionally, MC received honoraria as a consultant from AB MEDICA for workshop participation and from PROMEDON for research and development expertise, and honoraria from MEDTRONIC for symposium presentation. MC is a member of the pelviperineology group of the national gynecologic French society (Honorary, unpaid role) and the past president of the Société Internationale Francophone d'Urodynamique et de Pelvi-Périnéologie (SIFUD-PP) (Honorary, unpaid role).

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