Abstract
Introduction and hypothesis
Evidence and recommendations for the use of intravaginal estrogen for prevention of bacterial vaginosis and pessary-related complications are limited and controversial. We hypothesized that adding intravaginal estrogen to pessary use would decrease the incidence of bacterial vaginosis and other pessary-related complications.
Methods
A single-center, open-label, randomized, parallel study was conducted between April 2018 and August 2020. Participants were randomized to either receive intravaginal estriol 0.03 mg plus Lactobacillus acidophilus 100 million viable cell vaginal tablets or have no treatment. The Amsel criteria, normal flora index, visual analog scale, Thai version of the ICIQ-VS (International Consultation on Incontinence Questionnaire-Vaginal symptoms) questionnaire, vaginal abrasions and vaginal bleeding were evaluated at entry and at 2- and 14-week follow-up.
Results
Seventy-eight women were included and randomized to two groups (39 women per group). At 2-week follow-up, one participant in the intervention group and two participants in the control group were diagnosed with bacterial vaginosis (2.7% vs. 5.7%, p = 0.609). At 14-week follow-up, two participants in the intervention group and two participants in the control group were diagnosed with bacterial vaginosis (5.7% vs. 6.2%, p = 0.926). Normal flora index was significantly different at 2-week follow-up [8 (6.3) vs. 5 (6.0), p = 0.032]. There was no significant difference in the visual analog scale, Thai version of the ICIQ-VS, vaginal abrasions and vaginal bleeding between the 2- and 14-week follow-ups.
Conclusions
This study shows no benefit of intravaginal estrogen in reducing bacterial vaginosis, vaginal abrasions, vaginal bleeding and pain in postmenopausal women using a vaginal pessary for pelvic organ prolapse treatment.
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References
Haylen BT, de Ridder D, Freeman RM, Swift SE, Berghmans B, Lee J, et al. An International Urogynecological Association (IUGA)/International Continence Society (ICS) joint report on the terminology for female pelvic floor dysfunction. Neurourol Urodyn. 2010;29(1):4–20. https://doi.org/10.1002/nau.20798.
Chuenchompoonut V, Bunyavejchevin S, Wisawasukmongchol W, Taechakraichana N. Prevalence of genital prolapse in Thai menopausal women (using new standardization classification). J Med Assoc Thailand = Chotmaihet thangphaet. 2005;88(1):1–4.
Wu JM, Hundley AF, Fulton RG, Myers ER. Forecasting the prevalence of pelvic floor disorders in US women: 2010 to 2050. Obstet Gynecol. 2009;114(6):1278–83. https://doi.org/10.1097/AOG.0b013e3181c2ce96.
Practice Bulletin No. 176. Pelvic organ prolapse. Obstet Gynecol. 2017;129(4):e56–72. https://doi.org/10.1097/aog.0000000000002016.
Clemons JL, Aguilar VC, Tillinghast TA, Jackson ND, Myers DL. Risk factors associated with an unsuccessful pessary fitting trial in women with pelvic organ prolapse. Am J Obstet Gynecol. 2004;190(2):345–50. https://doi.org/10.1016/j.ajog.2003.08.034.
Cundiff GW, Amundsen CL, Bent AE, Coates KW, Schaffer JI, Strohbehn K, et al. The PESSRI study: symptom relief outcomes of a randomized crossover trial of the ring and Gellhorn pessaries. Am J Obstet Gynecol. 2007;196(4):405.e401–8. https://doi.org/10.1016/j.ajog.2007.02.018.
Albertsen PC. Patient satisfaction and changes in prolapse and urinary symptoms in women who were fitted successfully with a pessary for pelvic organ prolapse. J Urol. 2005;173(3):942–3.
Fernando RJ, Thakar R, Sultan AH, Shah SM, Jones PW. Effect of vaginal pessaries on symptoms associated with pelvic organ prolapse. Obstet Gynecol. 2006;108(1):93–9. https://doi.org/10.1097/01.AOG.0000222903.38684.cc.
Wu V, Farrell SA, Baskett TF, Flowerdew G. A simplified protocol for pessary management. Obstet Gynecol. 1997;90(6):990–4.
Culligan PJ. Nonsurgical management of pelvic organ prolapse. Obstet Gynecol. 2012;119(4):852–60. https://doi.org/10.1097/AOG.0b013e31824c0806.
Alnaif B, Drutz HP. Bacterial vaginosis increases in pessary users. Int Urogynecol J Pelvic Floor Dysfunct. 2000;11(4):219–22 discussion 222-213.
Coelho SCA, Giraldo PC, Florentino JO, Castro EB, Brito LGO, Juliato CRT. Can the pessary use modify the vaginal microbiological flora? A cross-sectional study. Revista brasileira de ginecologia e obstetricia: revista da Federacao Brasileira das Sociedades de Ginecologia e Obstetricia. 2017;39(4):169–74. https://doi.org/10.1055/s-0037-1601437.
Collins S, Beigi R, Mellen C, O’Sullivan D, Tulikangas P. The effect of pessaries on the vaginal microenvironment. Am J Obstet Gynecol. 2015;212(1):60.e61–6. https://doi.org/10.1016/j.ajog.2014.07.024.
Bachmann GA, Nevadunsky NS. Diagnosis and treatment of atrophic vaginitis. Am Fam Physician. 2000;61(10):3090–6.
Lethaby A, Ayeleke RO, Roberts H. Local oestrogen for vaginal atrophy in postmenopausal women. Cochrane Database System Rev. 2016;8:Cd001500. https://doi.org/10.1002/14651858.CD001500.pub3.
Ismail SI, Bain C, Hagen S. Oestrogens for treatment or prevention of pelvic organ prolapse in postmenopausal women. Cochrane Database System Rev. 2010;9:Cd007063. https://doi.org/10.1002/14651858.CD007063.pub2.
Dessie SG, Armstrong K, Modest AM, Hacker MR, Hota LS. Effect of vaginal estrogen on pessary use. Int Urogynecol J. 2016;27(9):1423–9. https://doi.org/10.1007/s00192-016-3000-1.
Bulchandani S, Toozs-Hobson P, Verghese T, Latthe P. Does vaginal estrogen treatment with support pessaries in vaginal prolapse reduce complications? Post Reproduct Health. 2015;21(4):141–5. https://doi.org/10.1177/2053369115614704.
Jaisamrarn U, Triratanachat S, Chaikittisilpa S, Grob P, Prasauskas V, Taechakraichana N. Ultra-low-dose estriol and lactobacilli in the local treatment of postmenopausal vaginal atrophy. Climacteric: J Intl Menopause Soc. 2013;16(3):347–55. https://doi.org/10.3109/13697137.2013.769097.
Sriwat W, Manonai J, Sillaphakit C, Sarit-apirak S, Chittacharoen A. Validation of the Thai version of ICIQ-VS (Internaltional consultation on incontinence questionnaire-vaginal symptoms in Thai women). Rama Med J. 2016;39:1–13.
Amsel R, Totten PA, Spiegel CA, Chen KC, Eschenbach D, Holmes KK. Nonspecific vaginitis. Diagnostic criteria and microbial and epidemiologic associations. Am J Med. 1983;74(1):14–22.
Petersen EE. Significance of lactobacilli as normal flora. Der Gynakologe. 1985;18(3):128–30.
Ozkinay E, Terek MC, Yayci M, Kaiser R, Grob P, Tuncay G. The effectiveness of live lactobacilli in combination with low dose oestriol (Gynoflor) to restore the vaginal flora after treatment of vaginal infections. BJOG :Intl J Obstet Gynaecol. 2005;112(2):234–40. https://doi.org/10.1111/j.1471-0528.2004.00329.x.
Price N, Jackson SR, Avery K, Brookes ST, Abrams P. Development and psychometric evaluation of the ICIQ vaginal symptoms questionnaire: the ICIQ-VS. BJOG: Intl J Obstet Gynaecol. 2006;113(6):700–12. https://doi.org/10.1111/j.1471-0528.2006.00938.x.
Acknowledgements
The authors gratefully acknowledge Ms. Sumanee Nilgate, Department of Microbiology, King Chulalongkorn Memorial Hospital, and the Thai Red Cross Society for assistance with the normal flora index interpretation.
Funding
This study was funded by the Ratchadapisek Sompoch research grant (RA61/027).
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Chiengthong: Project development, Data Collection, Manuscript writing.
Ruanphoo: Project development.
Chatsuwan: Project development.
Bunyavejchevin: Project development, Manuscript editing.
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Chiengthong, K., Ruanphoo, P., Chatsuwan, T. et al. Effect of vaginal estrogen in postmenopausal women using vaginal pessary for pelvic organ prolapse treatment: a randomized controlled trial. Int Urogynecol J 33, 1833–1838 (2022). https://doi.org/10.1007/s00192-021-04821-y
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DOI: https://doi.org/10.1007/s00192-021-04821-y