Journal of South Asian Federation of Obstetrics and Gynaecology

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VOLUME 14 , ISSUE 6 ( November-December, 2022 ) > List of Articles

ORIGINAL RESEARCH

Efficacy of Polycarbophil Moisturizing Gel in Women with Genitourinary Syndrome of Menopause: A Randomized Control Trial

Junita Indarti, Ranti Pratiwi Permatasari, Rabbania Hiksas

Keywords : Genitourinary syndrome of menopause, Polycarbophil, Vaginal health index score, Vaginal moisturizer

Citation Information : Indarti J, Permatasari RP, Hiksas R. Efficacy of Polycarbophil Moisturizing Gel in Women with Genitourinary Syndrome of Menopause: A Randomized Control Trial. J South Asian Feder Obs Gynae 2022; 14 (6):719-723.

DOI: 10.5005/jp-journals-10006-2155

License: CC BY-NC 4.0

Published Online: 31-01-2023

Copyright Statement:  Copyright © 2022; The Author(s).


Abstract

Introduction: Menopausal symptoms have defected the quality of life of elderly women. Several studies have examined a nonhormonal bioadhesive moisturizer gel, such as polycarbophil, for genitourinary syndrome of menopause (GSM) therapy. However, there was no such study in Indonesia. Thus, this study aims to compare the efficacy of polycarbophil moisturizer gel and placebo for women with GSM. Materials and methods: A randomized clinical trial with a total of 40 subjects was enrolled in Cipto Mangunkusumo General Hospital, Jakarta from April to December 2019. Subjects were divided into polycarbophil group (n = 21) and the placebo group (n = 19). Polycarbophil and placebo were given two times per week for 3 weeks. Genitourinary syndrome of menopause symptoms (vaginal dryness, itching, dyspareunia, dysuria, and burning sensation) and vaginal health index scores (VHIS), including vaginal elasticity, fluid volume, pH, epithelial integrity, and vaginal moisture, were assessed before and after the intervention. Results: Most of the GSM symptoms, especially vaginal dryness and dyspareunia, improved in week 2 for both interventions. Related to VHIS, polycarbophil gel improved the vaginal fluid volume, pH, and moisture, while placebo improved epithelial integrity. The polycarbophil gel was found to significantly (p <0.001) raise the vaginal pH compared with placebo. Overall, there were 18 subjects (85.7%) from the polycarbophil group who felt an improvement of symptoms after therapy, while only 11 subjects (57.9%) from the control group felt it. Conclusion: Polycarbophil gel may raise vaginal pH in postmenopausal women with GSM. The overall VHIS efficacy between polycarbophil and placebo was relatively the same.


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  1. Portman DJ, Gass MLS. Genitourinary syndrome of menopause: new terminology for vulvovaginal atrophy from the International Society for the Study of Women's Sexual Health and the North American Menopause Society. Menopause 2014;21(10):1063–1068. DOI: 10.1097/GME.0000000000000329.
  2. Angelou K, Grigoriadis T, Diakosavvas M, et al. The genitourinary syndrome of menopause: An overview of the recent data. Cureus 2020;12(4):e7586. DOI: 10.7759/cureus.7586.
  3. Nappi RE, Martini E, Cucinella L, et al. Addressing vulvovaginal atrophy (VVA)/genitourinary syndrome of menopause (GSM) for healthy aging in women. Front Endocrinol 2019;10:561. DOI: 10.3389/fendo.2019.00561.
  4. Palacios S, Henderson VW, Siseles N, et al. Age of menopause and impact of climacteric symptoms by geographical region. Climacteric 2010;13(5):419–428. DOI: 10.3109/13697137.2010.507886.
  5. Madjid TH, Biben A, Harun MH. Demographic survey of menarche and menopause at industrial area of Majalaya and Cijerah. Am J Res Commun 2015;3(4):1–20.
  6. Octavani C, Meiyanti M. The relationship of menopause with depression among women over 50 years old. J Kedokt dan Kesehat Indones 2019;10(1):50–56. DOI: 10.20885/JKKI.Vol10.Iss1.art8.
  7. Mirhaghjou SN, Niknami M, Moridi M, et al. Quality of life and its determinants in postmenopausal women: A population-based study. Appl Nurs Res 2016;30:252–256. DOI: 10.1016/j.apnr.2015.10.004.
  8. Farrell Am E. Genitourinary syndrome of menopause. Aust Fam Physician 2017;46(7):481–484. PMID: 28697291
  9. Management of symptomatic vulvovaginal atrophy: 2013 position statement of The North American Menopause Society. Menopause 2013;20(9):888–902. DOI: 10.1097/GME.0b013e3182a122c2.
  10. Bachmann GA, Notelovitz M, Kelly SJ, et al. Long-term non-hormonal treatment of vaginal dryness. Clin Pr Sex 1992;8:3–8. DOI: 10.1097/GME.0b013e3181a48c4e.
  11. Gold EB. The timing of the age at which natural menopause occurs. Obstet Gynecol Clin North Am 2011;38(3):425–440. DOI: 10.1016/j.ogc.2011.05.002
  12. Vale F, Rezende C, Raciclan A, et al. Efficacy and safety of a non-hormonal intravaginal moisturizer for the treatment of vaginal dryness in postmenopausal women with sexual dysfunction. Eur J Obstet Gynecol Reprod Biol 2019;234:92–95. DOI: 10.1016/j.ejogrb.2018.12.040
  13. Edwards D, Panay N. Treating vulvovaginal atrophy/genitourinary syndrome of menopause: How important is vaginal lubricant and moisturizer composition? Climacteric 2016;19(2):151–161. DOI: 10.3109/13697137.2015.1124259.
  14. Amabebe E, Anumba DOC. The vaginal microenvironment: The physiologic role of Lactobacilli. Front Med 2018;5:181. DOI: 10.3389/fmed.2018.00181.
  15. Melis GB, Piras B, Marotto MF, et al. The stimulation of the vaginal immune system with short-term administration of a vaginal gel containing fraction of Propionibacterium acnes, hyaluronic acid and polycarbophil is efficacious in vaginal infections dependent on disorders in the vaginal ecosystem. Gynecol Endocrinol 2018;34(10):880–883. DOI: 10.1080/09513590.2018.1460345
  16. Chuery ACS, de Góis Speck NM, de Moura KFQ, et al. Efficacy of vaginal use of topical estriol in postmenopausal women with urogenital atrophy. Clin Exp Obstet Gynecol 2011;38(2):143–145. PMID: 21793275.
  17. Zhu Z, Zhai Y, Zhang N, et al. The development of polycarbophil as a bioadhesive material in pharmacy. Asian J Pharm Sci 2013;8(4):218–227. DOI: 10.1016/j.ajps.2013.09.003
  18. Mitchell CM, Reed SD, Diem S, et al. Efficacy of vaginal estradiol or vaginal moisturizer vs placebo for treating postmenopausal vulvovaginal symptoms: A randomized clinical trial. JAMA Intern Med 2018;178(5):681–690. DOI: 10.1001/jamainternmed.2018.0116.
  19. Richardson BA, Kelly C, Ramjee G, et al. Appropriateness of hydroxyethylcellulose gel as a placebo control in vaginal microbicide trials: A comparison of the two control arms of HPTN 035. J Acquir Immune Defic Syndr 2013;63(1):120–125. DOI: 10.1097/QAI.0b013e31828607c5.
  20. Yodplob T, Sirisopana K, Jongwannasiri M, et al. Local treatment with a polycarbophil-based cream in postmenopausal women with genitourinary syndrome of menopause. Int Urogynecol J 2021;32(2):317–322. DOI: 10.1007/s00192-020-04282-9.
  21. Palacios S, Mejía A, Neyro JL. Treatment of the genitourinary syndrome of menopause. Climacteric 2015;18(Suppl 1):23–29. DOI: 10.3109/13697137.2015.1079100.
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