Vaginal lubricants: efficacy, tolerability, safety and functionality
- Authors: Stenyaeva N.N.1, Sattarova V.V.2, Pashkevich K.I.2, Khritinin D.F.3, Osipova O.A.2, Stenyaev E.Y.4
-
Affiliations:
- Academician V.I. Kulakov National Medical research Center for Obstetrics, Gynecology and Perinatology, Ministry of Health of Russia
- "Biorhythm" Laboratory LLC
- I.M. Sechenov First Moscow State Medical University, Ministry of Health of Russia (Sechenov University)
- Belarusian State Medical University
- Issue: No 8 (2023)
- Pages: 203-210
- Section: Guidelines for the Practitioner
- URL: https://journals.eco-vector.com/0300-9092/article/view/595698
- DOI: https://doi.org/10.18565/aig.2023.179
- ID: 595698
Cite item
Abstract
A systematic analysis of the information available in modern literature (Medscape, Medline, PubMed, eLibrary, CyberLeninka, Google scholar databases in 2010–2022) on the safety, tolerability, efficacy and features of the use of vaginal lubricants was carried out. The main types of chemical composition and physiological characteristics of vaginal lubricants are presented; targeted lubricants are considered in the light of clinical situations. A number of studies have convincingly shown that the intrinsic toxicity of individual components of lubricants, in addition to pH and osmolality, are of great importance for the their safety. When developing lubricants, special attention is paid to safety issues, not only from the point of view of the impact on the mucous membrane and microbiota of the woman's vagina, but also compatibility with germ cells, fertilization and embryos for couples who are not protected from pregnancy, as well as for use by medical workers during manipulations in assisted reproductive technology programs. For patients with symptoms of vulvovaginal atrophy (VVA), lubricants are an alternative to hormone therapy; when applied to the tissues of the vulvovaginal region, they eliminate the effects of dryness, provide moisture to the mucosa, and increase the index of vaginal health. The osmolality of the gel does not affect the viability of lactobacilli. Lubricant microbiocides are the most convenient way to use special antiseptics against sexually transmitted infections (STIs) with proven activity. Some lubricants contain special additives enhancing the genital sexual response during sexual intercourse.
Conclusion: The analysis of scientific data confirms the feasibility of widespread use of lubricants for sexual dysfunction, as moisturizers for VVA, as well as the possibility of their using during pregnancy, for postcoital cystitis, to reduce the risk of infection with STIs during sexual intercourse.
Full Text
![Restricted Access](https://journals.eco-vector.com/lib/pkp/templates/images/icons/text_lock.png)
About the authors
Natalya N. Stenyaeva
Academician V.I. Kulakov National Medical research Center for Obstetrics, Gynecology and Perinatology, Ministry of Health of Russia
Author for correspondence.
Email: nataliasten@mail.ru
ORCID iD: 0000-0002-6495-3367
Ph.D., Senior Researcher at the Department of Andrology and Urology
Russian Federation, MoscowValeria V. Sattarova
"Biorhythm" Laboratory LLC
Email: SVV73@yahoo.com
Chief Specialist
Russian Federation, YekaterinburgKazimir I. Pashkevich
"Biorhythm" Laboratory LLC
Email: info@bior.ru
Dr. Sci. (Chemistry), Professor, Director
Russian Federation, YekaterinburgDmitry F. Khritinin
I.M. Sechenov First Moscow State Medical University, Ministry of Health of Russia (Sechenov University)
Email: nataliasten@mail.ru
ORCID iD: 0000-0001-9107-2357
Corresponding Member of RAS, Dr. Med. Sci., Professor at the Department of Psychiatry and Narcology, Faculty of Medicine
Russian Federation, MoscowOlga A. Osipova
"Biorhythm" Laboratory LLC
Email: formulator@bior.ru
Ph.D., Head of the Quality Control Division
Russian Federation, YekaterinburgEvgeny Yu. Stenyaev
Belarusian State Medical University
Email: nataliasten@mail.ru
5th year student of the Medical Faculty of Foreign Students of the Educational Institution
Belarus, MinskReferences
- Стеняева Н.Н. Болевое сексуальное расстройство. Медицинский совет. 2022; 16(16): 130-4. [Stenyaeva N.N. Sexual pain disorder. Medical Council. 2022;(16):130-4. (in Russian)]. https://dx.doi.org/10.21518/ 2079-701X-2022-16-16-130-134.
- Portman D.J., Gass M.L.; Vulvovaginal Atrophy Terminology Consensus Conference Panel. 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. Maturitas. 2014; 79(3): 349-54. https://dx.doi.org/10.1016/j.maturitas.2014.07.013.
- Kingsberg S.A., Wysocki S., Magnus L., Krychman M.L. Vulvar and vaginal atrophy in postmenopausal women: findings from the REVIVE (REal Women's VIews of Treatment Options for Menopausal Vaginal ChangEs) survey. J. Sex. Med. 2013; 10(7): 1790-9. https://dx.doi.org/10.1111/jsm.12190.
- Palma F., Volpe A., Villa P., Cagnacci A.; Writing group of AGATA study. Vaginal atrophy of women in postmenopause. Results from a multicentric observational study: The AGATA study. Maturitas. 2016; 83: 40-4. https://dx.doi.org/10.1016/j.maturitas.2015.09.001.
- Krychman M., Millheiser L.S. Sexual health issues in women with cancer. J. Sex. Med. 2013;10(Suppl. 1): 5-15. https://dx.doi.org/10.1111/jsm.12034.
- Lindau S.T., Dude A., Gavrilova N., Hoffmann J.N., Schumm L.P., McClintock M.K. Prevalence and correlates of vaginal estrogenization in postmenopausal women in the United States. Menopause. 2017; 24(5): 536-45. https://dx.doi.org/10.1097/GME.0000000000000787.
- Calleja-Agius J., Brincat M.P. The urogenital system and the menopause. Climacteric. 2015;18(Suppl. 1): 18-22. https://dx.doi.org/10.3109/ 13697137.2015.1078206.
- Ito K., Takamatsu K., Nohno K., Sugano A., Funayama S., Katsura K. et al. Factors associated with mucosal dryness in multiple regions and skin: A web-based study in women. J. Obstet. Gynaecol. Res. 2017; 43(5): 880-6. https://dx.doi.org/10.1111/jog.13290.
- Kachnic L.A., Bruner D.W., Qureshi M.M., Russo G.A. Perceptions and practices regarding women's vaginal health following radiation therapy: a survey of radiation oncologists practicing in the United States. Pract. Radiat. Oncol. 2017; 7(5): 356-63. https://dx.doi.org/10.1016/ j.prro.2017.02.003.
- Foerster R., Schnetzke L., Bruckner T., Arians N., Rief H., Debus J., Lindel K. Prognostic factors for long-term quality of life after adjuvant radiotherapy in women with endometrial cancer. Strahlenther. Onkol. 2016; 192(12): 895-904. https://dx.doi.org/10.1007/s00066-016-1037-1.
- Стеняева Н.Н., Красный А.М., Григорьев В.Ю. Сухость влагалища: молекулярно-биологические и сексологические аспекты. Эффективная фармакотерапия. 2017; 44: 26-33. [Stenyaeva N.N., Krasny A.M., Grigoryev V.Yu. Vaginal dryness: Molecular biological and sexological aspects. Effective Pharmacotherapy. 2017; 44: 26-33. (in Russian)].
- Herbenick D., Reece M., Hensel D., Sanders S., Jozkowski K., Fortenberry J.D. Association of lubricant use with women’s sexual pleasure, sexual satisfaction, and genital symptoms: a prospective daily diary study. J. Sex. Med. 2011; 8(1): 202-12. https://dx.doi.org/10.1111/j.1743-6109.2010.02067.x.
- Maldonado P.A., Montoya T.I., Acevedo J.F., Keller P.W., Word R.A. Effects of vaginal conjugated equine estrogens and ospemifene on the rat vaginal wall and lower urinary tract. Biol. Reprod. 2017; 96(1): 81-92. https://dx.doi.org/10.1095/biolreprod.116.144428.
- Ayehuniea S., Wangb Y.-Y., Landrya T., Bogojevica S., Coneb R.A. Hyperosmolal vaginal lubricants markedly reduce epithelial barrier properties in a three-dimensional vaginal epithelium mode. Toxicol. Rep. 2017; 5: 134-40. https://dx.doi.org/10.1016/j.toxrep.2017.12.011.
- Adriaens E., Remon J.P. Mucosal irritation potential of personal lubricants relates to product osmolality as detected by the slug mucosal irritation assay. Sex. Transm. Dis. 2008; 35(5): 512-6. https://dx.doi.org/10.1097/OLQ.0b013e3181644669.
- Use and procurement of additional lubricants with male and female condoms: WHO/UNFPA/FHI360. Advisory Note; 2012.
- Доброхотова Ю.Э., Ибрагимова Д.М., Мандрыкина Ж.А. Микробиоценоз генитального тракта женщины. 2-е изд. М.: ГЭОТАР-Медиа; 2023. 96с. [Dobrokhotova Yu.E., Ibragimova D.M., Mandrykina Zh.A. Microbiocenosis of the genital tract of women. 2nd ed., revision and supplement. Мoscow: GEOTAR-Media; 2023. 96p. (in Russian)].
- Dezzutti C.S., Brown E.R., Moncla B., Russo J., Cost M., Wang L. et al. Is wetter better? An evaluation of over-the-counter personal lubricants for safety and anti-HIV-1 activity. PLoS One. 2012; 7(11): e48328. https://dx.doi.org/10.1371/journal.pone.0048328.
- Обоскалова Т.А., Пашкевич К.И., Саттарова В.В., Осипова О.А., Зверева К.Г. Оценка влияния вагинальных лубрикантов на состояние слизистой влагалища, кислотно-щелочной статус и состав вагинального микробиома у женщин репродуктивного возраста. Акушерство и гинекология. 2020; 9: 159-70. [Oboskalova T.A., Pashkevich K.I., Sattarova V.V., Osipova O.A., Zvereva K.G. Evaluation of the effect of vaginal lubricants on the vaginal mucosa, acid¬base status, and the composition of the vaginal microbiome in reproductive-aged women. Obstetrics and Gynecology. 2020; (9): 159-70. (in Russian)]. https://dx.doi.org/10.18565/aig.2020.9.159-170.
- Whaley K.J., Hanes J., Shattock R., Cone R.A., Friend D.R. Novel approaches to vaginal delivery and safety of microbicides: biopharmaceuticals, nanoparticles, and vaccines. Antiviral Res. 2010; 88(Suppl. 1): S55-66. https://dx.doi.org/10.1016/j.antiviral.2010.09.006.
- Gorbach P.M., Weiss R.E., Fuchs E., Jeffries R.A., Hezerah M., Brown S. et al. The slippery slope: lubricant use and rectal sexually transmitted infections: a newly identified risk. Sex. Transm. Dis. 2012; 39(1): 59-64. https://dx.doi.org/10.1097/OLQ.0b013e318235502b.
- Fashemi B., Delaney M.L., Onderdonk A.B., Fichorova R.N. Effects of feminine hygiene products on the vaginal mucosal biome. Microb. Ecol. Health Dis. 2013; 24. https://dx.doi.org/10.3402/ mehd.v24i0.19703.
- Cunha A.R., Machado R.M., Palmeira-de-Oliveira A., Martinez-de-Oliveira J., das Neves J., Palmeira-de-Oliveira R. Characterization of commercially available vaginal lubricants: a safety perspective. Pharmaceutics. 2014; 6(3): 530-42. https://dx.doi.org/10.3390/pharmaceutics6030530.
- ТР ТС 009/2011 Технический регламент Таможенного союза «О безопасности парфюмерно-косметической продукции». [TR TS 009/2011 Technical Regulations of the Customs Union "On the Safety of Perfumes and Cosmetics Products". (in Russian)].
- CFR 184.1490 (USFDA); U.S. National archives and records administration's electronic code of federal regulations. Available at: https://www.ecfr.gov Accessed 24.10.2016.
- Toxin and Toxin Target Database (T3DB). Available at: https://www.t3db.ca/toxins/T3D3979 Available at: https://www.t3db.ca/toxins/T3D3977
- Steiner A.Z., Long D.L., Tanner C. Effect of vaginal lubricants on natural fertility. Obstet. Gynecol. 2012; 120(1): 44-51. https://dx.doi.org/10.1097/AOG.0b013e31825b87ae.
- Wilson S.L., Adam J.K., Naidu Krishna S.B. Effects of vaginal lubricants on In-Vitro progressive spermatozoa motility. Afr. J. Reprod. Health. 2017; 21(3): 96-101. https://dx.doi.org/10.29063/ajrh2017/v21i3.9.
- United States Food and Drug Administration (2017) Product classification: lubricant, personal, gamete, fertilization, and embryo compatible.
- Ellington J.E., Clifton G.D. Gamete, fertilization and embryo compatible lubricants: The New FDA Product Code ‘PEB’ updates the standard of care for trying-to-conceive couples. J. Womens Health, Issues Care. 2017; 7: 1. https://dx.doi.org/10.4172/2325-9795.1000297.
- Обоскалова Т.А., Воронцова А.В., Звычайный М.А., Саттарова В.В. Вагинальные лубриканты как фактор коррекции трофической и секреторной функции слизистой влагалища в возрасте репродукции и менопаузального перехода. Уральский медицинский журнал. 2015; 5: 45-9. [Oboskalova T.A., Vorontsova A.V., Zvychainy M.A., Sattarova V.V. Vaginal lubricants as vagina mucous trophic and secret function correction factor in childbearing and menopausal age. Ural Medical Journal. 2015; (5): 45-9. (in Russian)].
- Nappi R.E., Benedetto C., Campolo F., Martella S., Tosti C., Cianci A. et al. Efficacy, tolerability and safety of a new medical device, Monurelle Biogel1 vaginal gel, in the treatment of vaginal dryness: a randomized clinical trial in women of reproductive age. Eur. J. Obstet. Gynecol. Reprod. Biol. 2016; 203: 82-8. https://dx.doi.org/10.1016/j.ejogrb.2016.05.005.
- Nappi R.E., Cagnacci A., Becorpi A.M., Nappi C., Paoletti A.M., Busacca M. et al. Monurelle Biogel vaginal gel in the treatment of vaginal dryness in postmenopausal women. Climacteric. 2017; 20(5): 467-75. https://dx.doi.org/ 10.1080/13697137.2017.1335703.
- Palacios S., Hood S., Abakah-Phillips T., Savania N., Krychman M. A randomized trial on the effectiveness and safety of 5 water-based personal lubricants. J. Sex. Med. 2023; 20(4): 498-506. https://dx.doi.org/10.1093/jsxmed/ qdad005.
- Protocol In-Vivo «User Test: Controlling Effect of BIOLIN P in Feminine Wash», GOBIOTICS BV, Netherlands, Date 1° Version: 26/05/2004 Version: 03; Date Revision: 25/07/2018 Revison: 01. Available at: https://www.gobiotics-ingredients.com
- Касихина Е.И. Хлоргексидин: обзор лечебных возможностей и потенциальных клинических показаний в практике акушера-гинеколога и венеролога. Акушерство и гинекология. 2013; 4: 4-9. [Kasikhina E.I. Chlorhexidine: a review of treatment options and potential clinical indications in the practice of an obstetrician/gynecologist and a venereologist. Obstetrics and Gynecology. 2013; (4): 4-9. (in Russian)].
Supplementary files
![](/img/style/loading.gif)