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The definition of Genitourinary Syndrome of Menopause (GSM) is the decline of estrogens during menopause results in symptoms and clinical signs from both systems. Estrogen and other hormones production decrease after menopause because the ovaries lose their effectiveness, leading to mucosal atrophy, reduced vaginal moisture, dysuria, urgency, recurrent infection, burning, pruritus and dyspareunia.
The treatment included vaginal estrogen supplement, vaginal hyaluronic acid supplement, vaginal laser, platelet rich plasma, etc. Observational cohort study will be used for study design, and questionnaire, pelvic examination, vaginal pap smear with maturation index (MI), vaginal pH, and other methods will be used for evaluation of the effectiveness and side effects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Genital urinary symptoms of menopause | Menopause for one year, or age above 45 with symptoms of GSM |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vaginal estrogen supplement | Drug | Daily vaginal estrogen supplement, then twice per week. Continue for three months. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Visual analogue scale (VAS) | Changes in GSM symptoms include vaginal dryness, dyspareunia, itching, burning, dysuria | 2022/8/10-2024/2/28 |
| Vaginal health index score (VHIS) | One of the most commonly used scores for the evaluation of vaginal elasticity, secretions, pH, the presence of petechiae on the epithelial mucosa, and hydration | 2022/8/10-2024/2/28 |
| Female Sexual Function Index (FSFI) | A brief multidimensional scale for assessing sexual function in women. | 2022/8/10-2024/2/28 |
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Inclusion Criteria:
Exclusion Criteria:
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Menopause for one year Age above 45 with symptoms of GSM
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hui-Hsuan Lau | Contact | +886-25433535 | huihsuan1220@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Hui-Hsuan Lau | Mackay Memorial Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| MacKay Memorial Hospital | Taipei | 104 | Taiwan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27472999 | Background | Gandhi J, Chen A, Dagur G, Suh Y, Smith N, Cali B, Khan SA. Genitourinary syndrome of menopause: an overview of clinical manifestations, pathophysiology, etiology, evaluation, and management. Am J Obstet Gynecol. 2016 Dec;215(6):704-711. doi: 10.1016/j.ajog.2016.07.045. Epub 2016 Jul 26. | |
| 28778337 | Background |
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| Platelet-rich plasma injection | Procedure | Monthly platelet-rich plasma injection for three months |
|
| Pitsouni E, Grigoriadis T, Falagas ME, Salvatore S, Athanasiou S. Laser therapy for the genitourinary syndrome of menopause. A systematic review and meta-analysis. Maturitas. 2017 Sep;103:78-88. doi: 10.1016/j.maturitas.2017.06.029. Epub 2017 Jun 27. |
| 30103082 | Background | Pitsouni E, Grigoriadis T, Douskos A, Kyriakidou M, Falagas ME, Athanasiou S. Efficacy of vaginal therapies alternative to vaginal estrogens on sexual function and orgasm of menopausal women: A systematic review and meta-analysis of randomized controlled trials. Eur J Obstet Gynecol Reprod Biol. 2018 Oct;229:45-56. doi: 10.1016/j.ejogrb.2018.08.008. Epub 2018 Aug 6. |
| 30798700 | Background | Najjarzadeh M, Mohammad Alizadeh Charandabi S, Mohammadi M, Mirghafourvand M. Comparison of the effect of hyaluronic acid and estrogen on atrophic vaginitis in menopausal women: A systematic review. Post Reprod Health. 2019 Jun;25(2):100-108. doi: 10.1177/2053369119830818. Epub 2019 Feb 24. No abstract available. |
| 35194935 | Background | Saleh DM, Abdelghani R. Clinical evaluation of autologous platelet rich plasma injection in postmenopausal vulvovaginal atrophy: A pilot study. J Cosmet Dermatol. 2022 Oct;21(10):4269-4275. doi: 10.1111/jocd.14873. Epub 2022 Mar 7. |