Clinical Evidence Regarding Spermidine–Hyaluronate Gel as a Novel Therapeutic Strategy in Vestibulodynia Management
<b>Background:</b> 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...
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2024-11-01
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| author | Filippo Murina Alessandra Graziottin Nicla Toni Maria Teresa Schettino Luca Bello Alessandra Marchi Barbara Del Bravo Dania Gambini Lara Tiranini Rossella Elena Nappi |
| author_facet | Filippo Murina Alessandra Graziottin Nicla Toni Maria Teresa Schettino Luca Bello Alessandra Marchi Barbara Del Bravo Dania Gambini Lara Tiranini Rossella Elena Nappi |
| author_sort | Filippo Murina |
| collection | DOAJ |
| description | <b>Background:</b> 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. <b>Objectives</b>: A prospective observational trial was performed to confirm the efficacy of a topical gel containing a spermidine–hyaluronate complex (UBIGEL donna™) as either a stand-alone or companion treatment through a multicenter study on a large sample population. <b>Methods</b>: 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. <b>Results</b>: A total of 154 patients treated with UBIGEL donna™ 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 (<i>p</i> < 0.0001). These improvements were consistent across various stratifications, including age and disease duration. <b>Conclusions</b>: The findings of the present study suggest that UBIGEL donna™ is effective in alleviating pain and dyspareunia, as well as reducing vestibular hypersensitivity in women with VBD. Although UBIGEL donna™ 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. |
| format | Article |
| id | doaj-art-e60fa39928884d7b830ca02a38de64a3 |
| institution | DOAJ |
| issn | 1999-4923 |
| language | English |
| publishDate | 2024-11-01 |
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| spelling | doaj-art-e60fa39928884d7b830ca02a38de64a32025-08-20T02:48:07ZengMDPI AGPharmaceutics1999-49232024-11-011611144810.3390/pharmaceutics16111448Clinical Evidence Regarding Spermidine–Hyaluronate Gel as a Novel Therapeutic Strategy in Vestibulodynia ManagementFilippo Murina0Alessandra Graziottin1Nicla Toni2Maria Teresa Schettino3Luca Bello4Alessandra Marchi5Barbara Del Bravo6Dania Gambini7Lara Tiranini8Rossella Elena Nappi9Lower Genital Tract Disease Unit, V. Buzzi Hospital, University of the Study of Milan, 20122 Milan, ItalyCentre of Gynaecology and Medical Sexology, Department of Obstetrics and Gynaecology, San Raffaele Resnati Hospital, 20097 Milan, ItalyIsola Tiberina Hospital-Gemelli Isola, 00186 Rome, ItalyDepartment of Woman, Child and General and Specialized Surgery, University of Campania “Luigi Vanvitelli”, 80138 Naples, ItalyCe.Mu.S.S., ASL Città Di Torino, 10128 Turin, ItalyPrivate Clinic Centro Salute Pelvi (CSP), 10123 Turin, ItalyStudio Del Bravo Private Clinic, 56121 Pisa, ItalyGraziottin Foundation for the Management and Treatment of Pain in Women, NPO, 20097 Milan, ItalyDepartment of Clinical, Surgical, Diagnostic and Pediatric Sciences, University of Pavia, Viale Golgi 19, 27100 Pavia, ItalyDepartment of Clinical, Surgical, Diagnostic and Pediatric Sciences, University of Pavia, Viale Golgi 19, 27100 Pavia, Italy<b>Background:</b> 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. <b>Objectives</b>: A prospective observational trial was performed to confirm the efficacy of a topical gel containing a spermidine–hyaluronate complex (UBIGEL donna™) as either a stand-alone or companion treatment through a multicenter study on a large sample population. <b>Methods</b>: 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. <b>Results</b>: A total of 154 patients treated with UBIGEL donna™ 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 (<i>p</i> < 0.0001). These improvements were consistent across various stratifications, including age and disease duration. <b>Conclusions</b>: The findings of the present study suggest that UBIGEL donna™ is effective in alleviating pain and dyspareunia, as well as reducing vestibular hypersensitivity in women with VBD. Although UBIGEL donna™ 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.https://www.mdpi.com/1999-4923/16/11/1448vulvodyniavestibulodyniaspermidinedyaspareunia |
| spellingShingle | Filippo Murina Alessandra Graziottin Nicla Toni Maria Teresa Schettino Luca Bello Alessandra Marchi Barbara Del Bravo Dania Gambini Lara Tiranini Rossella Elena Nappi Clinical Evidence Regarding Spermidine–Hyaluronate Gel as a Novel Therapeutic Strategy in Vestibulodynia Management Pharmaceutics vulvodynia vestibulodynia spermidine dyaspareunia |
| title | Clinical Evidence Regarding Spermidine–Hyaluronate Gel as a Novel Therapeutic Strategy in Vestibulodynia Management |
| title_full | Clinical Evidence Regarding Spermidine–Hyaluronate Gel as a Novel Therapeutic Strategy in Vestibulodynia Management |
| title_fullStr | Clinical Evidence Regarding Spermidine–Hyaluronate Gel as a Novel Therapeutic Strategy in Vestibulodynia Management |
| title_full_unstemmed | Clinical Evidence Regarding Spermidine–Hyaluronate Gel as a Novel Therapeutic Strategy in Vestibulodynia Management |
| title_short | Clinical Evidence Regarding Spermidine–Hyaluronate Gel as a Novel Therapeutic Strategy in Vestibulodynia Management |
| title_sort | clinical evidence regarding spermidine hyaluronate gel as a novel therapeutic strategy in vestibulodynia management |
| topic | vulvodynia vestibulodynia spermidine dyaspareunia |
| url | https://www.mdpi.com/1999-4923/16/11/1448 |
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