{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,6,8]],"date-time":"2026-06-08T01:19:19Z","timestamp":1780881559665,"version":"3.54.1"},"reference-count":27,"publisher":"MDPI AG","issue":"11","license":[{"start":{"date-parts":[[2024,11,12]],"date-time":"2024-11-12T00:00:00Z","timestamp":1731369600000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Pharmaceutics"],"abstract":"<jats:p>Background: Vestibulodynia (VBD) represents a summation and overlapping of trigger factors (infections, hormonal disturbances, allergies, genetic aspects, psychological vulnerability, and others) with broad individual variability. As there are no standard treatment options for VBD, the disease is still in need of appropriate therapeutic tools. Objectives: A prospective observational trial was performed to confirm the efficacy of a topical gel containing a spermidine\u2013hyaluronate complex (UBIGEL donna\u2122) as either a stand-alone or companion treatment through a multicenter study on a large sample population. Methods: For women with VBD (n = 154), the treatment consisted of approximately two months (4 + 4 weeks) of applications according to the posology of UBIGEL. Evaluation of symptoms was performed on relevant clinical endpoints: dyspareunia and vulvovaginal pain\/burning by a visual scale (VAS); vestibular trophism by a vestibular trophic health (VeTH) score; vulvoscopy through a cotton swab test; and the level of hypertonic pelvic floor by a physical graded assessment of levator ani hypertonus. Results: A total of 154 patients treated with UBIGEL donna\u2122 showed significant improvements across all five evaluated parameters, including pain, dyspareunia, swab test results, muscle hypertonicity, and vestibular trophism. Pain and dyspareunia scores decreased by 46.5% and 33.5%, respectively, while significant improvements were also observed in the other parameters (p &lt; 0.0001). These improvements were consistent across various stratifications, including age and disease duration. Conclusions: The findings of the present study suggest that UBIGEL donna\u2122 is effective in alleviating pain and dyspareunia, as well as reducing vestibular hypersensitivity in women with VBD. Although UBIGEL donna\u2122 alone cannot serve as a comprehensive substitute for all recommended therapies, we suggest that multimodal therapy strategies may be crucial for attaining substantial improvement in any aspect of the condition.<\/jats:p>","DOI":"10.3390\/pharmaceutics16111448","type":"journal-article","created":{"date-parts":[[2024,11,12]],"date-time":"2024-11-12T09:36:51Z","timestamp":1731404211000},"page":"1448","update-policy":"https:\/\/doi.org\/10.3390\/mdpi_crossmark_policy","source":"Crossref","is-referenced-by-count":3,"title":["Clinical Evidence Regarding Spermidine\u2013Hyaluronate Gel as a Novel Therapeutic Strategy in Vestibulodynia Management"],"prefix":"10.3390","volume":"16","author":[{"given":"Filippo","family":"Murina","sequence":"first","affiliation":[{"name":"Lower Genital Tract Disease Unit, V. Buzzi Hospital, University of the Study of Milan, 20122 Milan, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Alessandra","family":"Graziottin","sequence":"additional","affiliation":[{"name":"Centre of Gynaecology and Medical Sexology, Department of Obstetrics and Gynaecology, San Raffaele Resnati Hospital, 20097 Milan, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Nicla","family":"Toni","sequence":"additional","affiliation":[{"name":"Isola Tiberina Hospital-Gemelli Isola, 00186 Rome, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Maria","family":"Schettino","sequence":"additional","affiliation":[{"name":"Department of Woman, Child and General and Specialized Surgery, University of Campania \u201cLuigi Vanvitelli\u201d, 80138 Naples, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Luca","family":"Bello","sequence":"additional","affiliation":[{"name":"Ce.Mu.S.S., ASL Citt\u00e0 Di Torino, 10128 Turin, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Alessandra","family":"Marchi","sequence":"additional","affiliation":[{"name":"Private Clinic Centro Salute Pelvi (CSP), 10123 Turin, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Barbara","family":"Del Bravo","sequence":"additional","affiliation":[{"name":"Studio Del Bravo Private Clinic, 56121 Pisa, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Dania","family":"Gambini","sequence":"additional","affiliation":[{"name":"Graziottin Foundation for the Management and Treatment of Pain in Women, NPO, 20097 Milan, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0001-2981-9269","authenticated-orcid":false,"given":"Lara","family":"Tiranini","sequence":"additional","affiliation":[{"name":"Department of Clinical, Surgical, Diagnostic and Pediatric Sciences, University of Pavia, Viale Golgi 19, 27100 Pavia, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-1713-6396","authenticated-orcid":false,"given":"Rossella","family":"Nappi","sequence":"additional","affiliation":[{"name":"Department of Clinical, Surgical, Diagnostic and Pediatric Sciences, University of Pavia, Viale Golgi 19, 27100 Pavia, Italy"},{"name":"Research Center for Reproductive Medicine and Gynecological Endocrinology\u2014Menopause Unit, IRCCS S Matteo Foundation, 27100 Pavia, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"1968","published-online":{"date-parts":[[2024,11,12]]},"reference":[{"key":"ref_1","doi-asserted-by":"crossref","first-page":"9","DOI":"10.1111\/jmwh.13456","article-title":"Evaluation and Treatment of Vulvodynia: State of the Science","volume":"68","author":"Schlaeger","year":"2023","journal-title":"J. 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