Acceptability of and treatment preferences for recurrent bacterial vaginosis—Topical lactic acid gel or oral metronidazole antibiotic: Qualitative findings from the VITA trial

Abstract Background Bacterial vaginosis (BV) affects 30–50% of women at some time in their lives and is an embarrassing and distressing condition which can be associated with potentially serious comorbidities. Current antibiotic treatments such as metronidazole are effective but can result in side effects, and recurrence is common. This trial aims to investigate whether lactic acid gel is clinically effective and cost effective in the treatment of recurrent BV compared with metronidazole. Methods VITA is an open-label, multicentre, parallel group randomised controlled trial for women with a clinical diagnosis of BV and at least one previous BV episode in the past 2 years. Participants will be randomised 1:1 to intravaginal lactic acid gel 5 ml once daily for 7 days or oral metronidazole tablets 400 mg twice daily for 7 days. All participants will be followed up for 6 months to assess health status and healthcare costs. A subgroup will be interviewed to further explore adherence, tolerability and acceptability of treatment. The estimated sample size is 1900 participants to detect a 6% absolute increase in response rate to 86% in those receiving lactic acid gel. The primary outcome is participant-reported resolution of BV at Week 2. Discussion Results from this trial will help inform UK treatment guidelines for BV and may provide an alternative effective treatment for recurrent episodes of this condition which avoids repeated exposure to antibiotics. Trial registration ISRCTN, ISRCTN14161293. Registered on 8 September 2017.

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The Effect of Oral Metronidazole on the Vaginal Microbiome of Patients with Recurrent Bacterial Vaginosis: A Pilot Investigational Study

Human Microbiome Journal ◽

10.1016/j.humic.2021.100081 ◽

2021 ◽

pp. 100081

Author(s):

Oluwatosin Goje ◽

Elizabeth O. Shay ◽

Metabel Markwei ◽

Roshan Padmanabhan ◽

Charis Eng

Keyword(s):

Bacterial Vaginosis ◽

Vaginal Microbiome ◽

Oral Metronidazole

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Clindamycin Vaginal Cream Versus Oral Metronidazole in the Treatment of Bacterial Vaginosis

Southern Medical Journal ◽

10.1097/00007611-199211000-00006 ◽

1992 ◽

Vol 85 (11) ◽

pp. 1077-1080 ◽

Cited By ~ 24

Author(s):

FRANK J. ANDRES ◽

REBECCA PARKER ◽

IAN HOSEIN ◽

GUY I. BENRUBI

Keyword(s):

Bacterial Vaginosis ◽

Vaginal Cream ◽

Oral Metronidazole

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Correction to: Vaginal treatment with lactic acid gel delays relapses in recurrent urinary tract infections: results from an open, multicentre observational study

Archives of Gynecology and Obstetrics ◽

10.1007/s00404-021-06093-9 ◽

2021 ◽

Author(s):

Ruth Diebold ◽

Bettina Schopf ◽

Holger Stammer ◽

Werner Mendling

Keyword(s):

Lactic Acid ◽

Urinary Tract ◽

Observational Study ◽

Urinary Tract Infections ◽

Recurrent Urinary Tract Infections ◽

Acid Gel ◽

Tract Infections

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Prognostic Indicators of Recurrence of Bacterial Vaginosis

Journal of Clinical Microbiology ◽

10.1128/jcm.00227-19 ◽

2019 ◽

Vol 57 (5) ◽

Cited By ~ 3

Author(s):

Jack D. Sobel ◽

Navkiranjot Kaur ◽

Nicole A. Woznicki ◽

Dina Boikov ◽

Tina Aguin ◽

...

Keyword(s):

Bacterial Vaginosis ◽

Prognostic Value ◽

Prognostic Indicators ◽

Recurrence Rates ◽

Predictive Values ◽

Prognostic Tests ◽

Index Tests ◽

Treatment Alternatives ◽

Cessation Of Treatment ◽

Oral Metronidazole

ABSTRACTFollowing all forms of therapy for bacterial vaginosis (BV), recurrence rates are extremely high. Many diagnostic tests are available that differentiate bacterial vaginosis from other types of vaginal disorders, but none predict recurrence after treatment, nor are any vetted for monitoring ongoing responses to treatment. Our goal was to determine which tests, and at what optimal times, have prognostic value in predicting recurrence. This prospective cohort study monitored 74 highly recurrent BV patients for up to 9 months. Symptomatic BV patients were treated with oral metronidazole and were evaluated at cessation of treatment and monthly. Index tests included Amsel, Nugent, BV Blue, and Affirm VPIII, as well as a quantitative PCR (qPCR)-based test under initial evaluation here. The qPCR-based LbRC (LactobacillusRelativeComposition) assay predicted BV recurrence when performed shortly after oral metronidazole treatment, with both 90% positive predictive values (PPV) and 74% negative predictive values (NPV); the Nugent scores had 93% PPV but poor NPV (57%). No test, at any other visit, was prognostic. The LbRC assay and, to a lesser extent, Nugent tests scored a week after oral metronidiazole predicted recurrence, suggesting that the recurrence in this cohort was predominantly by relapse due to incomplete restoration of eubiosis soon after therapy. This is the first study in an under evaluated population of recurrent BV patients that emphasizes the need for and a pathway to a possible prognostic modality. Given the high recurrence rates of BV, prognostic tests that could influence individualized treatment alternatives are urgently needed.

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Combined vaginal administration of nystatin, diiodohydroxyquin, and benzalkonium chloride versus oral metronidazole for the treatment of bacterial vaginosis

International Journal of Gynecology & Obstetrics ◽

10.1002/ijgo.12805 ◽

2019 ◽

Vol 145 (3) ◽

pp. 261-267

Author(s):

Wichinee Chooprasertsuk ◽

Woraluk Somboonporn ◽

Sukree Soontrapa ◽

LingLing Salang ◽

Siriruthai Amnatbuddee

Keyword(s):

Bacterial Vaginosis ◽

Benzalkonium Chloride ◽

Vaginal Administration ◽

Oral Metronidazole

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Treating male partners of women with bacterial vaginosis (StepUp): a protocol for a randomised controlled trial to assess the clinical effectiveness of male partner treatment for reducing the risk of BV recurrence

BMC Infectious Diseases ◽

10.1186/s12879-020-05563-w ◽

2020 ◽

Vol 20 (1) ◽

Author(s):

Lenka A. Vodstrcil ◽

◽

Erica L. Plummer ◽

Michelle Doyle ◽

Christopher K. Fairley ◽

...

Keyword(s):

Randomised Controlled Trial ◽

Bacterial Vaginosis ◽

Controlled Trial ◽

Male Partner ◽

Standard Of Care ◽

Trial Registration ◽

Current Standard ◽

Randomised Controlled ◽

Oral Metronidazole ◽

Amsel Criteria

Abstract Background Bacterial vaginosis (BV) is estimated to affect 1 in 3 women globally and is associated with obstetric and gynaecological sequelae. Current recommended therapies have good short-term efficacy but 1 in 2 women experience BV recurrence within 6 months of treatment. Evidence of male carriage of BV-organisms suggests that male partners may be reinfecting women with BV-associated bacteria (henceforth referred to as BV-organisms) and impacting on the efficacy of treatment approaches solely directed to women. This trial aims to determine the effect of concurrent male partner treatment for preventing BV recurrence compared to current standard of care. Methods StepUp is an open-label, multicentre, parallel group randomised controlled trial for women diagnosed with BV and their male partner. Women with clinical-BV defined using current gold standard diagnosis methods (≥3 Amsel criteria and Nugent score (NS) = 4–10) and with a regular male partner will be assessed for eligibility, and couples will then be consented. All women will be prescribed oral metronidazole 400 mg twice daily (BID) for 7 days, or if contraindicated, a 7-day regimen of topical vaginal 2% clindamycin. Couples will be randomised 1:1 to either current standard of care (female treatment only), or female treatment and concurrent male partner treatment (7 days of combined antibiotics - oral metronidazole tablets 400 mg BID and 2% clindamycin cream applied topically to the glans penis and upper shaft [under the foreskin if uncircumcised] BID). Couples will be followed for up to 12 weeks to assess BV status in women, and assess the adherence, tolerability and acceptability of male partner treatment. The primary outcome is BV recurrence defined as ≥3 Amsel criteria and NS = 4–10 within 12 weeks of enrolment. The estimated sample size is 342 couples, to detect a 40% reduction in BV recurrence rates from 40% in the control group to 24% in the intervention group within 12 weeks. Discussion Current treatments directed solely to women result in unacceptably high rates of BV recurrence. If proven to be effective the findings from this trial will directly inform the development of new treatment strategies to impact on BV recurrence. Trial registration The trial was prospectively registered on 12 February 2019 on the Australian and New Zealand Clinical Trial Registry (ACTRN12619000196145, Universal Trial Number: U1111–1228-0106, https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=376883&isReview=true).

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