The assessment of anti-recurrence efficacy of Prodexin in the treatment of bacterial vaginosis

Authors

DOI:

https://doi.org/10.18370/2309-4117.2025.77.57-63

Keywords:

PRO-BAVAG study, bacterial vaginosis, recurrence, Prodexyn, ternidazole, metronidazole, adherence to treatment

Abstract

Background. Bacterial vaginosis (BV) remains the most common vaginal infection globally, often exhibiting high recurrence rates despite standard antimicrobial therapy. The persistence of BV is frequently attributed to polymicrobial biofilms and altered vaginal microbiota, which challenge conventional treatment efficacy.

Objective of the study: To assess the long-term anti-relapse effectiveness and patient adherence associated with Prodexyn (a combination of octenidine dihydrochloride and dexpanthenol) compared to standard topical antimicrobial agents in women with a history of recurrent BV.

Materials and methods. In this prospective comparative study (phase II of the PRO-BAVAG project), 119 women with a previous history of BV recurrence were enrolled and stratified based on previous treatment regimens. Participants received either Prodexyn (n = 52), ternidazole (n = 41), or metronidazole (n = 26). Recurrence was evaluated using clinical symptoms and Hay-Ison criteria at 3, 6, and 9 months. Treatment adherence was measured using the MMAS-8 scale.

Results. No recurrences were recorded in the Prodexyn group after 3 months. At 6 and 9 months, the recurrence rate remained significantly lower in the Prodexyn group compared to both comparison groups (p < 0.05). Additionally, high adherence to therapy was noted in 92.3% of Prodexyn users, significantly outperforming adherence in the metronidazole and ternidazole groups (p < 0.01). The probable reason for the better anti-relapse effect of Prodexin can be considered the biofilm-targeting effect of octenidine and its lactoflora preserving effect.

Conclusions. Prodexyn demonstrated superior long-term efficacy in preventing BV recurrence and showed high patient adherence. Its dual action (targeting vaginal biofilms and preserving lactoflora) suggests a promising alternative to traditional antimicrobial therapies. Further studies are needed to confirm its biofilm-disruptive mechanisms and define optimal treatment durations.

Author Biographies

D.G. Konkov, Andriy Tkachenko Educational and Scientific Institute of Innovative Medical and Educational Technologies, Shupyk National Healthcare University of Ukraine, Kyiv

MD, professor, Director

V.O. Rud, Vinnytsya National Pirogov Memorial Medical University, Vinnytsia

MD, professor, Department of Obstetrics and Gynecology No. 2

A.V. Starovier, Vinnytsia National Pirogov Medical University, Vinnytsia

PhD, associate professor, Department of Obstetrics and Gynecology No. 1

O.A. Muntyan, Vinnytsia National Pirogov Medical University, Vinnytsia

PhD, associate professor, Department of Obstetrics and Gynecology No. 2

References

  1. Mitchell CM, Abbe CR. Bacterial vaginosis: a review of approaches to treatment and prevention. Front Reproductive Health. 2023;5:1100029. DOI:10.3389/frph.2023.1100029.
  2. Peebles K, Velloza J, Balkus JE, et al. High global burden and costs of bacterial vaginosis: a systematic review and meta-analysis. Sex Transm Dis. 2019;46(5):304–11. DOI:10.1097/OLQ.0000000000000972.
  3. Sobel JD, Sobel R. Current and emerging pharmacotherapy for recurrent bacterial vaginosis. Expert Opin. Pharmacother. 2021;22:1593–600. DOI: 10.1080/14656566.2021.1904890.
  4. Swidsinski S, Moll WM, Swidsinski A. Bacterial Vaginosis-Vaginal Polymicrobial Biofilms and Dysbiosis. Dtsch Arztebl Int. 2023 May 19;120(20):347–354. DOI: 10.3238/arztebl.m2023.0090.
  5. Abou Chacra L, Fenollar F, Diop K. Bacterial Vaginosis: What Do We Currently Know? Front Cell Infect Microbiol. 2022 Jan 18;11:672429. DOI: 10.3389/fcimb.2021.672429.
  6. Flores-Treviño S, Bocanegra-Ibarias P, Salas-Treviño D, et al. Microbiota transplantation and administration of live biotherapeutic products for the treatment of dysbiosis-associated diseases. Expert Opin Biol Ther. 2025 Mar 26. DOI: 10.1080/14712598.2025.2484303.
  7. Rosca AS, Castro J, Sousa LGV, Cerca N. Gardnerella and vaginal health: the truth is out there. FEMS Microbiol Rev. 2019;44(1):73–105. DOI: 10.1093/femsre/ fuz027.
  8. Tomás M, Palmeira-de-Oliveira A, Simões S, et al. Bacterial vaginosis: standard treatments and alternative strategies. Int J Pharm. 2020;587:119659. DOI: 10.1016/j.ijpharm.2020.119659.
  9. Watkins E, Lin J, Lingohr-Smith M, et al. Biological, clinical, and sociobehavioral factors associated with disproportionate burden of bacterial vaginosis in the United States: A Comprehensive Literature Review. J Womens Health (Larchmt). 2025 Mar 10. DOI: 10.1089/jwh.2024.0583.
  10. Schwebs T, Kieninger AK, Podpera Tisakova L, et al. Evaluation of Metronidazole Resistance of Vaginal Swab Isolates from South African Women Treated for Bacterial Vaginosis. Antibiotics (Basel). 2024 Dec 14;13(12):1217. DOI: 10.3390/antibiotics13121217.
  11. Abbe C, Mitchell CM. Bacterial vaginosis: a review of approaches to treatment and prevention. Front Reprod Health. 2023 May 31;5:1100029. DOI: 10.3389/frph.2023.1100029.
  12. Afifirad R, Emamie AD, Zadeh RG, et al. Effects of Pro/Prebiotics Alone over Pro/Prebiotics Combined with Conventional Antibiotic Therapy to Treat Bacterial Vaginosis: A Systematic Review. Int J Clin Pract. 2022:4774783. DOI: 10.1155/2022/4774783
  13. Ruiz-Perez D, Coudray MS, Colbert B, et al. Effect of metronidazole on vaginal microbiota associated with asymptomatic bacterial vaginosis. Access Microbiol. 2021;3:000226. DOI: 10.1099/acmi.0.000226.
  14. Ashraf S, Haroon A, Fayyaz A. Comparing the efficacy of probiotic plus antibiotic with the Antibiotic Therapy alone on the recurrence of Bacterial Vaginosis. Pak J Med Sci. 2025 Jan;41(1):125–9. DOI: 10.12669/pjms.41.1.9922.
  15. Surapaneni S, Akins R, Sobel JD. Recurrent bacterial vaginosis: an unmet therapeutic challenge. Experience with a combination pharmacotherapy long-term suppressive regimen. Sex Transm Dis. 2021;48(10):761. DOI: 10.1097/OLQ. 0000000000001420.
  16. Wang L, Chen L, Li Y, et al. Study on the efficacy of fractional CO2 laser treatment for vaginal relaxation syndrome combined with recurrent bacterial vaginitis. Sci Rep. 2025 Jan 9;15(1):1445. DOI: 10.1038/s41598-025-85661-4.
  17. Armstrong-Buisseret L, Brittain C, Kai J, et al. Lactic acid gel versus metronidazole for recurrent bacterial vaginosis in women aged 16 years and over: the VITA RCT. Health Technol Assess. 2022;26(2):1–170. DOI: 10.3310/ZZKH4176.
  18. Lev-Sagie A, Goldman-Wohl D, Cohen Y, et al. Vaginal microbiome transplantation in women with intractable bacterial vaginosis. Nat Med. 2019,25(10):1500–4. DOI: 10.1038/s41591-019-0600-6.
  19. Turner AN, Carr Reese P, Fields KS, et al. A blinded, randomized controlled trial of high-dose vitamin D supplementation to reduce recurrence of bacterial vaginosis. Am J Obstet Gynecol. 2014,211 (5):479.e1–479.e13. DOI: 10.1016/j.ajog.2014.06.023.
  20. Waldbaum AS, Schwebke JR, Paull JRA, et al. A phase 2, double-blind, multicenter, randomized, placebo-controlled, doseranging study of the efficacy and safety of Astodrimer Gel for the treatment of bacterial vaginosis. PLoS One. 2020;15(5):e0232394. DOI: 10.1371/journal.pone. 0232394.
  21. Landlinger C, Oberbauer V, Tisakova LP, et al. Preclinical data on the gardnerella-specific endolysin PM-477 indicate its potential to improve the treatment of bacterial vaginosis through enhanced biofilm removal and avoidance of resistance. Antimicrob Agents Chemother. 2022;66(5): e0231921. DOI: 10.1128/aac.02319-21.
  22. Li Y, Zhu W, Jiang Y, et al. Synthetic bacterial consortia transplantation for the treatment of Gardnerella vaginalis-induced bacterial vaginosis in mice. Microbiome. 2023 Mar 20;11(1):54. DOI: 10.1186/s40168-023-01497-y.
  23. Rosca AS, Castro J, Sousa LGV, et al. Six bacterial vaginosis-associated species can form an in vitro and ex vivo polymicrobial biofilm that is susceptible to Thymbra capitata essential oil. Front Cell Infect Microbiol. 2022;12:1. DOI: 10.3389/fcimb.2022.824860.
  24. Konkov D, Starovier A., Bulavenko O, et al. The evaluation of the clinical efficacy of Prodexyn vaginal suppositories in the treatment of recurrent bacterial vaginosis. Reproductive endocrinology. 2024;75:37–43. DOI: 10.18370/2309-4117.2024.75.37-43.
  25. Powell A, Ghanem KG, Rogers L, et al. Clinicians’ Use of Intravaginal Boric Acid Maintenance Therapy for Recurrent Vulvovaginal Candidiasis and Bacterial Vaginosis. Sex Transm Dis. 2019 Dec;46(12):810–12. DOI: 10.1097/OLQ.0000000000001063.
  26. Deng ZL, Gottschick C, Bhuju S, et al. Metatranscriptome analysis of the vaginal microbiota reveals potential mechanisms for protection against Metronidazole in bacterial vaginosis. mSphere. 2018 Jun 6;3(3):e00262-18. DOI: 10.1128/mSphereDirect.00262-18.
  27. Ruiz-Perez D, Coudray MS, Colbert B, et al. Effect of metronidazole on vaginal microbiota associated with asymptomatic bacterial vaginosis. Access Microbiol. 2021;3:000226. DOI: 10.1099/acmi.0.000226.
  28. Muzny CA, Sobel JD. The role of antimicrobial resistance in refractory and recurrent bacterial vaginosis and current recommendations for treatment. Antibiotics. 2022;11(4). DOI:10.3390/antibiotics11040500.
  29. Workowski KA, Bachmann LH, Chan PA., et al. Sexually Transmitted Infections Treatment Guidelines, 2021. MMWR Recomm. Rep. 2021;70:1–187. DOI: 10.15585/mmwr.rr7004a1.
  30. Schwebke JR, Lensing SY, Lee J, et al. Treatment of male sexual partners of women with bacterial vaginosis: a randomized, double-blind, placebo-controlled trial. Clin. Infect. Dis. 2021;73:e672–e679. DOI: 10.1093/cid/ciaa1903.
  31. Sobel JD, Kaur N, A Woznicki N., et al. Conventional oral and secondary high dose vaginal metronidazole therapy for recurrent bacterial vaginosis: Clinical outcomes, impacts of sex and menses. Infect. Drug Resist. 2019;12:2297–2307. DOI: 10.2147/IDR.S213853.
  32. Aguin TJ, Akins RA, Sobel JD. High-dose vaginal metronidazole for recurrent bacterial vaginosis – A pilot study. J. Low Genit. Tract Dis. 2014;18:156–161. DOI: 10.1097/LGT.0b013e31829a5558.
  33. Sanchez S, Garcia PJ, Thomas KK, et al. Intravaginal metronidazole gel versus metronidazole plus nystatin ovules for bacterial vaginosis: A randomized controlled trial. Am. J. Obstet. Gynecol. 2004;191:1898–906. DOI: 10.1016/j.ajog.2004.06.089.
  34. Zhang R, Liu Z, Zhang Y, et al. Probiotics reduce the recurrence of asymptomatic bacterial vaginosis in Chinese women. Sci Rep. 2025 Mar 20;15(1):9689. DOI: 10.1038/s41598-025-92843-7.
  35. Van de Wijgert J, Verwijs MC. Lactobacilli-containing vaginal probiotics to cure or prevent bacterial or fungal vaginal dysbiosis: A systematic review and recommendations for future trial designs. BJOG. 2020;127:287–99. DOI: 10.1111/1471-0528.15870.
  36. Mitchell CM. Assessment and Treatment of Vaginitis. Obstet Gynecol. 2024 Dec 1;144(6):765–81. DOI: 10.1097/AOG.0000000000005673.
  37. Chow K, Wooten D, Annepally S, et al. Impact of (recurrent) bacterial vaginosis on quality of life and the need for accessible alternative treatments. BMC Womens Health. 2023 Mar 18;23(1):112. DOI: 10.1186/s12905-023-02236-z.
  38. Flores-Treviño S, Bocanegra-Ibarias P, Salas-Treviño D, et al. Microbiota transplantation and administration of live biotherapeutic products for the treatment of dysbiosis-associated diseases. Expert Opin Biol Ther. 2025 Mar 28:1–14. DOI: 10.1080/14712598.2025.2484303.
  39. Vodstrcil LA, Plummer EL, Fairley CK, et al; StepUp Team. Male-Partner Treatment to Prevent Recurrence of Bacterial Vaginosis. N Engl J Med. 2025 Mar 6;392(10):947–57. DOI: 10.1056/NEJMoa2405404.

Published

2025-05-30

How to Cite

Konkov, D., Rud, V., Starovier, A., & Muntyan, O. (2025). The assessment of anti-recurrence efficacy of Prodexin in the treatment of bacterial vaginosis. REPRODUCTIVE ENDOCRINOLOGY, (77), 57–63. https://doi.org/10.18370/2309-4117.2025.77.57-63

Issue

Section

Gynecology