TREATMENT OF VAGINAL DRYNESS IN SJÖGREN'S DISEASE WITH CO2-LASER VERSUS TOPICAL PROMESTRIENE

Summary

Sjögren's disease (SjD) is a chronic, immune-mediated, systemic inflammatory disease characterized mainly by involvement of the salivary and lacrimal glands, causing symptoms of sicca syndrome. The disease predominantly affects women (9:1 to 20:1), with a peak incidence between 40 and 60 years of age. Symptoms of dryness include those resulting from vaginitis sicca, such as vulvovaginal irritation, dryness, pruritus, dyspareunia, polyuria, nocturia, dysuria, and urinary urgency/incontinence, which may begin before and worsen after menopause. These symptoms impact the sexual life and health-related quality of life of SjD patients. However, there are no specific recommendations for the management of vaginal dryness in this disease. Urogenital syndrome (UGS), a condition that affects women from the general population in the menopausal phase, is characterized by similar symptoms and can be treated with systemic or local hormone therapy (e.g., topical promestriene). Current data also demonstrate the efficacy and safety of vaginal fractional CO2 laser treatment for UGS. However, there are no studies on the efficacy of vaginal fractional CO2 laser and topical promestriene in the treatment of vaginal dryness in SjD.

Timeline

Start

2026-02-27

Primary completion

2029-09-27

Completion

2030-01-30

Publications

• Background Abstracts of the International Continence Society 31st annual meeting. Seoul, Korea, 18-21 September 2001. Neurourol Urodyn. 2001;20(4):371-576. No abstract available.
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• Background Dall'Agno ML, Ferreira CF, Ferreira FV, Perez-Lopez FR, Wender MCO. Validation of the Six-item Female Sexual Function Index in Middle-Aged Brazilian Women. Rev Bras Ginecol Obstet. 2019 Jul;41(7):432-439. doi: 10.1055/s-0039-1692694. Epub 2019 Jul 25.
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• Background van Nimwegen JF, van der Tuuk K, Liefers SC, Verstappen GM, Visser A, Wijnsma RF, Vissink A, Hollema H, Mourits MJE, Bootsma H, Kroese FGM. Vaginal dryness in primary Sjogren's syndrome: a histopathological case-control study. Rheumatology (Oxford). 2020 Oct 1;59(10):2806-2815. doi: 10.1093/rheumatology/keaa017.
• Background van Nimwegen JF, Arends S, van Zuiden GS, Vissink A, Kroese FG, Bootsma H. The impact of primary Sjogren's syndrome on female sexual function. Rheumatology (Oxford). 2015 Jul;54(7):1286-93. doi: 10.1093/rheumatology/keu522. Epub 2015 Feb 4.
• Background Shiboski CH, Shiboski SC, Seror R, Criswell LA, Labetoulle M, Lietman TM, Rasmussen A, Scofield H, Vitali C, Bowman SJ, Mariette X; International Sjogren's Syndrome Criteria Working Group. 2016 American College of Rheumatology/European League Against Rheumatism Classification Criteria for Primary Sjogren's Syndrome: A Consensus and Data-Driven Methodology Involving Three International Patient Cohorts. Arthritis Rheumatol. 2017 Jan;69(1):35-45. doi: 10.1002/art.39859. Epub 2016 Oct 26.
• Background Serrano EV, Valim V, Miyamoto ST, Giovelli RA, Paganotti MA, Cade NV. Transcultural adaptation of the "EULAR Sjogren's Syndrome Disease Activity Index (ESSDAI)" into Brazilian Portuguese. Rev Bras Reumatol. 2013 Nov-Dec;53(6):483-93. doi: 10.1016/j.rbr.2013.04.003. English, Portuguese.
• Background Seror R, Ravaud P, Mariette X, Bootsma H, Theander E, Hansen A, Ramos-Casals M, Dorner T, Bombardieri S, Hachulla E, Brun JG, Kruize AA, Praprotnik S, Tomsic M, Gottenberg JE, Devauchelle V, Devita S, Vollenweider C, Mandl T, Tzioufas A, Carsons S, Saraux A, Sutcliffe N, Vitali C, Bowman SJ; EULAR Sjogren's Task Force. EULAR Sjogren's Syndrome Patient Reported Index (ESSPRI): development of a consensus patient index for primary Sjogren's syndrome. Ann Rheum Dis. 2011 Jun;70(6):968-72. doi: 10.1136/ard.2010.143743. Epub 2011 Feb 22.
• Background Seror R, Ravaud P, Bowman SJ, Baron G, Tzioufas A, Theander E, Gottenberg JE, Bootsma H, Mariette X, Vitali C; EULAR Sjogren's Task Force. EULAR Sjogren's syndrome disease activity index: development of a consensus systemic disease activity index for primary Sjogren's syndrome. Ann Rheum Dis. 2010 Jun;69(6):1103-9. doi: 10.1136/ard.2009.110619. Epub 2009 Jun 28.
• Background Seganfredo IB, Bianchi C, Tacla M, Chedraui P, Haddad JM, Simoes R, Baracat EC, Soares JM Jr. Comparison of promestriene with vaginal fractional CO2 laser and radiofrequency treatments of genitourinary syndrome of menopause. Maturitas. 2024 Aug;186:108008. doi: 10.1016/j.maturitas.2024.108008. Epub 2024 Apr 24.
• Background Samuels JB, Garcia MA. Treatment to External Labia and Vaginal Canal With CO2 Laser for Symptoms of Vulvovaginal Atrophy in Postmenopausal Women. Aesthet Surg J. 2019 Jan 1;39(1):83-93. doi: 10.1093/asj/sjy087.
• Background Salvatore S, Ruffolo AF, Phillips C, Athanasiou S, Cardozo L, Serati M; EUGA Working Group. Vaginal laser therapy for GSM/VVA: where we stand now - a review by the EUGA Working Group on Laser. Climacteric. 2023 Aug;26(4):336-352. doi: 10.1080/13697137.2023.2225766. Epub 2023 Jul 3.
• Background Priori R, Minniti A, Derme M, Antonazzo B, Brancatisano F, Ghirini S, Valesini G, Framarino-dei-Malatesta M. Quality of Sexual Life in Women with Primary Sjogren Syndrome. J Rheumatol. 2015 Aug;42(8):1427-31. doi: 10.3899/jrheum.141475. Epub 2015 Jul 1.
• Background Politano CA, Costa-Paiva L, Aguiar LB, Machado HC, Baccaro LF. Fractional CO2 laser versus promestriene and lubricant in genitourinary syndrome of menopause: a randomized clinical trial. Menopause. 2019 Aug;26(8):833-840. doi: 10.1097/GME.0000000000001333.
• Background Piccioni MG, Merlino L, Deroma M, Del Prete F, Tabacco S, Monti M, Benedetti Panici P. The impact of primary Sjogren's syndrome on female sexual function. Minerva Ginecol. 2020 Feb;72(1):50-54. doi: 10.23736/S0026-4784.20.04494-9.
• Background Paganotti MA, Valim V, Serrano EV, Miyamoto ST, Giovelli RA, Santos MC. Validation and psychometric properties of the Eular Sjogren's Syndrome Patient Reported Index (ESSPRI) into Brazilian Portuguese. Rev Bras Reumatol. 2015 Sep-Oct;55(5):439-45. doi: 10.1016/j.rbr.2015.06.004. Epub 2015 Aug 6. English, Portuguese.
• Background Miyamoto ST, Serrano EV, Gianordoli APE, Altoe LB, Noronha BD, Dos Santos PHA, Pedrini APT, da Silva NRS, Favarato LF, Alochio LV, Tome WA, Lackner A, Valim V. Brazilian version of the "Primary Sjogren's Syndrome - Quality of Life questionnaire (PSS-QoL)": translation, cross-cultural adaptation and validation. Adv Rheumatol. 2024 Aug 19;64(1):60. doi: 10.1186/s42358-024-00395-7.
• Background Miyamoto ST, Paganotti MA, Serrano EV, Giovelli RA, Valim V. Assessment of fatigue and dryness in primary Sjogren's syndrome: Brazilian version of "Profile of Fatigue and Discomfort - Sicca Symptoms Inventory (short form) (PROFAD-SSI-SF)". Rev Bras Reumatol. 2015 Mar-Apr;55(2):113-22. doi: 10.1016/j.rbr.2014.10.002. Epub 2014 Nov 7.
• Background Lackner A, Stradner MH, Hermann J, Unger J, Stamm T, Graninger WB, Dejaco C. Assessing health-related quality of life in primary Sjogren's syndrome-The PSS-QoL. Semin Arthritis Rheum. 2018 Aug;48(1):105-110. doi: 10.1016/j.semarthrit.2017.11.007. Epub 2017 Nov 27.
• Background Isik H, Isik M, Aynioglu O, Karcaaltincaba D, Sahbaz A, Beyazcicek T, Harma MI, Demircan N. Are the women with Sjogren's Syndrome satisfied with their sexual activity? Rev Bras Reumatol Engl Ed. 2017 May-Jun;57(3):210-216. doi: 10.1016/j.rbre.2017.01.002. Epub 2017 Feb 8. English, Portuguese.
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• Background Gozukucuk M, Turkyilmaz E, Kucuksahin O, Erten S, Ustun Y, Yavuz AF. Effects of primary Sjogren's syndrome on female genitalia and sexual functions. Clin Exp Rheumatol. 2021 Nov-Dec;39 Suppl 133(6):66-72. doi: 10.55563/clinexprheumatol/spnjy5. Epub 2021 Oct 6.
• Background Filippini M, Porcari I, Ruffolo AF, Casiraghi A, Farinelli M, Uccella S, Franchi M, Candiani M, Salvatore S. CO2-Laser therapy and Genitourinary Syndrome of Menopause: A Systematic Review and Meta-Analysis. J Sex Med. 2022 Mar;19(3):452-470. doi: 10.1016/j.jsxm.2021.12.010. Epub 2022 Jan 29.
• Background Farenhorst CA, de Wolff L, Arends S, van Nimwegen JF, Kroese FGM, Verstappen GM, Bootsma H. Clinical determinants of vaginal dryness in patients with primary Sjogren's syndrome. Clin Exp Rheumatol. 2021 Nov-Dec;39 Suppl 133(6):73-79. doi: 10.55563/clinexprheumatol/hzveng. Epub 2021 Oct 7.
• Background Bowman SJ, Hamburger J, Richards A, Barry RJ, Rauz S. Patient-reported outcomes in primary Sjogren's syndrome: comparison of the long and short versions of the Profile of Fatigue and Discomfort--Sicca Symptoms Inventory. Rheumatology (Oxford). 2009 Feb;48(2):140-3. doi: 10.1093/rheumatology/ken426. Epub 2008 Dec 11.
• Background Alvisi S, Gava G, Orsili I, Giacomelli G, Baldassarre M, Seracchioli R, Meriggiola MC. Vaginal Health in Menopausal Women. Medicina (Kaunas). 2019 Sep 20;55(10):615. doi: 10.3390/medicina55100615.
• Background Aguiar LB, Politano CA, Costa-Paiva L, Juliato CRT. Efficacy of Fractional CO2 Laser, Promestriene, and Vaginal Lubricant in the Treatment of Urinary Symptoms in Postmenopausal Women: A Randomized Clinical Trial. Lasers Surg Med. 2020 Oct;52(8):713-720. doi: 10.1002/lsm.23220. Epub 2020 Jan 28.

Drugs

Indications