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Diagnosis, Treatment, and Management of Vaginitis - Adult/Pediatric - Ambulatory

Diagnosis, Treatment, and Management of Vaginitis - Adult/Pediatric - Ambulatory - Clinical Hub, UW Health Clinical Tool Search, UW Health Clinical Tool Search, Clinical Practice Guidelines, Infection and Isolation


1
Diagnosis, Treatment, and Management
of Vaginitis – Adult/Pediatric –
Ambulatory
Clinical Practice Guideline
Note: Active Table of Contents – Click to follow link
EXECUTIVE SUMMARY ........................................................................................ 3
SCOPE ................................................................................................................. 4
METHODOLOGY .................................................................................................. 5
INTRODUCTION .................................................................................................. 5
RECOMMENDATIONS ......................................................................................... 6
Risk Stratification & Diagnostic Testing ............................................................... 6
Treatment & Follow-up ..................................................................................... 10
Complementary and Alternative Therapies .................................................... 10
Bacterial Vaginosis......................................................................................... 10
Trichomoniasis ............................................................................................... 12
Vulvovaginal candidiasis ................................................................................ 13
UW HEALTH IMPLEMENTATION ........................................................................ 18
APPENDIX A. EVIDENCE GRADING SCHEME(S) ................................................... 19
REFERENCES ...................................................................................................... 20
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2


Contact for Content:
Name: Derrick Chen, MD – Pathology- General
Phone Number: (608) 265-5264
Email Address: dchen@uwhealth.org

Contact for Changes:
Name: Lindsey Spencer, MS- Center for Clinical Knowledge Management (CCKM)
Phone Number: (608) 890-6403
Email Address: lspencer2@uwhealth.org

Coordinating Team Members:
David Yang, MD – Pathology- General
Leanne Preston – Clinical Laboratories
Kelly Koglin – Clinical Laboratories
Joanna Ruchala, MD – Medicine- Internal Medicine/General
Nancy Fuller, MD – Medicine- Internal Medicine/General
Kira Connelly-Nelson, NP – Medicine- Internal Medicine/General
Stephanie North, RN – Medicine- Internal Medicine/General
Sarina Schrager, MD – Family Medicine- General
Abigail Studinger, PA-C – Family Medicine- General
Susan Golz, LPN – Family Medicine- General
Daniel Hammes, PA-C – Urgent Care
Ann Bagot, NP – Obstetrics/Gynecology
Kristina Krueger, NP – Obstetrics/Gynecology
Josh Vanderloo, PharmD – Drug Policy Program
Tyler Liebenstein, PharmD, BCPS-AQ ID - Pharmacy

Review Individuals/Bodies:
Paula Cody, MD – General Pediatric and Adolescent Medicine
Michelle Bryan, MD – Family Medicine- General
Hema Patel, MD – Family Medicine- General

Committee Approvals/Dates:
Clinical Knowledge Management (CKM) Council (Last Periodic Review: 07/27/2017)


Release Date: August 2017 | Next Review Date: August 2020














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3


Executive Summary
Guideline Overview
The three diseases most frequently associated with vaginal discharge are bacterial vaginosis,
Trichomonas vaginalis, and vulvovaginal candidiasis. This guideline provides recommendations
for the diagnosis and treatment of patients with a vagina who report or present with vaginal
symptoms.

Key Practice Recommendations
1. A risk-based testing strategy is recommended to promote empiric treatment prior to
diagnostic laboratory testing and exam in low risk populations and a full diagnostic work-up
in higher risk populations. (UW Health Very low quality evidence, weak/conditional
recommendation)
2. Laboratory tests with greater sensitivity are recommended in patients considered to be at
higher risk, while less sensitive and less costly tests may be used in lower risk patients. (UW
Health Low quality evidence, weak/conditional recommendation)
3. Providers should strive to order as many tests in combination, as clinically appropriate (e.g.,
may not order a test to evaluate for Trichomoniasis if no risk of sexual transmission). (UW
Health Low quality evidence, weak/conditional recommendation)
4. The choice of medication should individualized based on patient preferences, cost, patient
compliance, and any presence of allergies, intolerances, or history of response or adverse
reactions to prior treatments.1 (UW Health Low quality evidence, strong recommendation)
5. Follow-up evaluation is unnecessary if symptoms of bacterial vaginosis or vulvovaginal
candidiasis resolve.2(UW Health Low quality evidence, strong recommendation)
6. Due to the high rate of reinfection, retesting for T. vaginalis is recommended for all sexually
active patients within 3 months following initial treatment regardless of whether they believe
their sex partners were treated.2 (UW Health Very low quality evidence, weak/conditional
recommendation)

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4


Scope
Disease/Condition(s): Vaginitis including:
- Bacterial Vaginosis
- Vulvovaginal candidiasis
- Trichomoniasis

Clinical Specialty: Urgent Care, Primary Care, OB/GYN, Laboratory

Intended Users: Physicians, Advanced Practice Providers, Nursing Staff, Pharmacists

Objective(s):
ξ To outline the preferred diagnostic testing methods for symptomatic patients.
ξ To provide evidence-based recommendations for the treatment of vaginitis and
prevention of recurrent symptoms.

Target Population: Patients with a vagina of reproductive age (menarche to menopause) who
are symptomatic, with or without a diagnosis of vaginitis confirmed by laboratory testing.

Interventions and Practices Considered:
ξ Laboratory testing
ξ Pharmacotherapy
ξ Sexual activity counseling

Major Outcomes Considered:
ξ Symptom relief
ξ Prevention of recurrence

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5


Methodology
Methods Used to Collect/Select the Evidence:
Electronic database searches (e.g., PUBMED) were conducted by the guideline author(s) and
workgroup members to collect evidence for review. Expert opinion and clinical experience were
also considered during discussions of the evidence.

Methods Used to Formulate the Recommendations:
The workgroup members agreed to adopt recommendations developed by external
organizations and/or arrived at a consensus through discussion of the literature and expert
experience. All recommendations endorsed or developed by the guideline workgroup were
reviewed and approved by other stakeholders or committees (as appropriate).

Methods Used to Assess the Quality of the Evidence/Strength of the Recommendations:
Recommendations developed by external organizations maintained the evidence grade
assigned within the original source document and were adopted for use at UW Health.

Internally developed recommendations, or those adopted from external sources without an
assigned evidence grade, were evaluated by the guideline workgroup using an algorithm
adapted from the Grading of Recommendations Assessment, Development and Evaluation
(GRADE) methodology (see Figure 1 in Appendix A).

Rating Scheme for the Strength of the Evidence/Recommendations:
See Appendix A for the rating scheme(s) used within this document.

Recognition of Potential Health Care Disparities:
African American (51.6%) and Mexican American (32.1%) women have significantly higher
prevalence of bacterial vaginosis than white non-Hispanic women (23.2%).3 A report by Royce
et al. evaluating vaginal flora and vaginal pH of 842 women at 24–29 weeks of gestation, found
that vaginal pH and vaginal flora differed significantly by race/ethnicity; African Americans were
more likely to have a vaginal pH > or = 4.5, no lactobacilli, small gram‐variable and gram‐
negative rods, and Mobiluncus bacterial species compared to white women after controlling for
factors such as sociodemographic, sexual activity, sexually transmitted diseases, health
behavior, and sexual hygiene.4

Introduction
Vulvovaginal complaints are one of the most common reasons for women to seek medical
advice.5 The diagnosis of bacterial vaginosis, vulvovaginal candidiasis, or Trichomonas
vaginalis are often considered clinically and diagnostically as a group because of their
overlapping nature. A variety of options are available to diagnose vaginitis, including evaluation
for clinical criteria (i.e., Amsel’s Diagnostic Criteria) and laboratory testing (e.g., scored Gram
stain, microscopy (wet mount), vaginal yeast culture, amplified probe technique, etc.). This
guideline provides evidence-based recommendations for the testing and treatment of patients
with vulvovaginal symptoms and complaints of vaginal discharge.

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Recommendations
Risk Stratification & Diagnostic Testing
When making decisions regarding a diagnostic strategy, providers must consider the local
prevalence of each diagnosis, individual patient history and physical examination results,
laboratory testing characteristics, and cost. Unfortunately, an optimal diagnostic strategy is not
clearly defined in the literature. Many expert consensus groups and several low quality studies
question the accuracy and benefit of prescribing empiric therapy based on history and/or
physical exam alone due to the risks of misdiagnosis or missed diagnoses, high coinfection rate,
potential adverse effects from incorrect or delayed treatment, and overall lack of trust in the
accuracy of patient-reported symptoms.1,2,6-12 On the contrary, two low quality research studies
have challenged the utility of laboratory testing and have offered successful demonstrations of
telephone triage protocols.8,13 At UW Health, a risk-based testing strategy (Figure 1) can be
considered to promote empiric treatment prior to diagnostic evaluation in low risk populations
and a full diagnostic work-up in higher risk populations.8,13 (UW Health Very low quality evidence,
weak/conditional recommendation)

A complete description of symptoms and medical history should be obtained in all patients,
regardless of encounter type (e.g., office visit, telephone).2 (UW Health Moderate quality evidence,
strong recommendation) The medical history should include information on sexual behaviors and
practices, gender of sex partners, menses, vaginal hygiene practices (e.g., douching), and any
self-treatment with medications available over-the-counter (OTC).2

All patients who present in the office with vulvovaginal symptoms, regardless of risk, should
receive a full physical examination and diagnostic testing prior to receiving vaginitis treatment.1
(UW Health Low quality evidence, strong recommendation)

Patients who report vulvovaginal symptoms via a telephone encounter, MyChart encounter, or
e-Visit should be evaluated for the presence of any high risk factors (Table 1). Patients who
exhibit any risk factors should not be treated for vaginitis without first having a full medical
history, physical examination, and laboratory testing performed. (UW Health Low quality evidence,
strong recommendation)

Table 1. High Risk Factors for Evaluation Prior to Treatment
ξ Age < 25 years11,14
ξ Systemic symptoms (e.g., fever, chills, body aches, etc.)13-15
ξ Abdominal or pelvic pain13,14
ξ New low back pain
ξ Pain with sexual intercourse5
ξ Unusual bleeding13
ξ Suspected exposure to a sexually transmitted infection or symptomatic sexual partner14
ξ New or multiple sexual partners2,5,14
ξ Over-the-counter or prescription treatment for vaginitis in the last 3 months5
ξ Previously prescribed empiric treatment over the telephone, MyChart, or e-Visit (max 2 per year)8
ξ Immunocompromised (e.g., HIV infection, uncontrolled diabetes mellitus)2,5
ξ Symptoms suggesting an alternative diagnosis (e.g., changes in skin condition or sores on the
genitals, presence of vaginal and urinary symptoms)
ξ Pregnancy or possible pregnancy*
*Special consideration should be given in this population; providers should decide individually based on patient
characteristics, history, and provider comfort whether to prescribe treatment without a full diagnostic evaluation.
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7


In the absence of any high risk factors (Table 1) or other symptoms, patients who report classic
symptoms of bacterial vaginosis or vulvovaginal candidiasis (Table 2) via a telephone
encounter, MyChart encounter, or e-Visit may receive empiric treatment prior to diagnostic
evaluation.8,13 (UW Health Very low quality evidence, weak/conditional recommendation) An office visit
should be scheduled in either patient population for a complete physical examination and
diagnostic evaluation if there is no resolution of symptoms within 2 weeks of treatment
initiation.13 (UW Health Low quality evidence, strong recommendation)

Table 2. Signs and Symptoms of Vaginitis5
Symptoms and
Clinical Signs
Diagnosis
Bacterial vaginosis Vulvovaginal
candidiasis
Trichomoniasis
Discharge Malodorous; homogenous; clear,
white, or gray; fishy odor
White, thick,
lack of odor
Green-yellow, frothy
Pain Not primary symptom Burning, dysuria,
dyspareunia
Pain with sexual intercourse, vaginal
soreness, dysuria
Pruritus Not primary symptom Frequent Not primary symptom
Vagina No signs of inflammation Signs of
inflammation, edema
Signs of inflammation,
“strawberry cervix”
Vulva Unaffected Excoriations Vestibular erythema may be present

When performing diagnostic tests, it is more cost-effective to perform a combination of
laboratory tests which assess for all three diagnoses rather than ordering tests sequentially.16
Providers should strive to order as many tests in combination as clinically appropriate (e.g., may
not need to order a test for Trichomoniasis if no risk of sexual transmission). (UW Health Very low
quality evidence, weak/conditional recommendation)

Various testing strategies are recommended to evaluate for the presence of bacterial vaginosis,
vulvovaginal candidiasis, and Trichomoniasis based on the clinical scenario (Table 3). Wet
mount microscopy performed by a skilled microscopist is the preferred testing method in most
symptomatic patients, due to the low cost and rapid availability of results at the point of care.5
(UW Health Low quality evidence, weak/conditional recommendation)

The low sensitivity of wet mount and risk for missed diagnoses has been challenged across the
literature, especially for T. vaginalis infection as it is associated with relatively significant health
consequences including increased risk for HIV acquisition, pelvic inflammatory disease, and
adverse pregnancy outcomes (e.g., premature rupture of membranes, preterm delivery, low
birth weight).2,5,17 Therefore, reflex testing for Trichomoniasis using a highly sensitive nucleic
acid amplification test (NAAT) is recommended in patients with a negative wet mount result to
improve the diagnostic sensitivity.2,18,19 (UW Health Low quality evidence, weak/conditional
recommendation) Concurrent screening for other sexually transmitted infections (e.g., chlamydia,
gonorrhea) should be considered in patients who are tested for T. vaginalis, and may even be
able to be performed from a single vaginal sample.17,20 (UW Health Low quality evidence,
weak/conditional recommendation)

Diagnostic tests with the highest sensitivity are recommended in patients who have failed
empiric therapy within 2 weeks of initiation or in patients with recurrent symptoms.19,21,22 (UW
Health Low quality evidence, weak/conditional recommendation) Unlike less sensitive testing
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8


methods, molecular testing (for bacterial vaginosis and Trichomonas) and culture (for
Candidiasis) can help to negate concerns for the risks associated with delays in appropriate
treatment and also provide the opportunity to identify organisms, such as C glabrata and C
krusei, which have demonstrated resistance to fluconazole and would require alternative
regimens.10

Researchers continue to evaluate the concordance between provider-collected and patient-
collected vaginal samples to diagnose vaginal infections. Self-obtained swabs have been used
successfully to diagnose other conditions, such as chlamydia and gonorrhea, and a high degree
of acceptability has been reported by patients.20,23 Although several studies have demonstrated
similar performance between self-collected and clinician-collected swabs, the anticipated
benefits of efficiency and cost savings with self-collection are not believed to outweigh the risk
for missed diagnoses.10,11,18,23,24 A comparison of “testing-only” visits with standard care visits at
three sexually transmitted disease clinics revealed 10.8% of symptomatic women would remain
undiagnosed with Trichomoniasis and 52.2% of BV/VVC cases would be missed using “testing-
only” visits.11 Furthermore, wet mounts prepared using patient-collected samples demonstrated
an even lower sensitivity than those prepared using a provider-collected sample.18,25

Table 3. Preferred Strategy by Clinical Scenario
Scenario(s) Bacterial vaginosis Vulvovaginal candidiasis Trichomoniasis**
Low risk

Initial presentation over
telephone encounter,
MyChart, or e-Visit
If classic symptoms, consider
treatment before lab testing.
Patients with atypical
symptoms should be
considered higher risk and
evaluated in the office.
If classic symptoms, consider
treatment before lab testing.
Patients with atypical symptoms
should be considered higher risk
and evaluated in the office.
N/A – Patients with risk factors for
Trichomonas are considered high risk
Low risk

Initial presentation in
office
Saline Wet Prep
with pH5
(provider or lab performed)
KOH Wet Prep5
(provider or lab performed)
Collect multiple swabs:
Saline Wet Prep5
(provider or lab performed)

If negative, consider reflex with
Trichomonas vaginalis by
Amplified Probe Technique19
High risk

Office presentation
required
Saline Wet Prep
with pH5
(provider or lab performed)
KOH Wet Prep5
(provider or lab performed)
Collect multiple swabs:
Saline Wet Prep5
(provider or lab performed)

If negative, consider reflex with
Trichomonas vaginalis by
Amplified Probe Technique19
Failed initial
treatment for BV or
VVC after 2 weeks
(Never tested)
Gram stain, vaginal for
bacterial vaginosis21
Vaginal Yeast Culture with
Smear22
N/A – Patients with risk factors for
Trichomonas are considered high risk
Recurrent infection
or symptoms
Gram stain, vaginal for
bacterial vaginosis21
Vaginal Yeast Culture with
Smear22
Trichomonas vaginalis by
Amplified Probe Technique19
** Consider screening for other sexually transmitted infections (e.g., chlamydia, gonorrhea, etc.).


Copyright © 2017 Univ ersity of Wisconsin Hospitals and Clinics Authority
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9


Figure 1. Management of Symptomatic Vaginitis Patients based on Risk


Patient reports vulvovaginal
symptoms
Presence of any
high risk factors?
Classic BV
symptoms?
Classic VVC
symptoms?
Prescribe treatment
Resolution of
symptoms within
2 weeks?
Recommend OTC
treatment or prescribe
treatment
No follow-up needed.
Obtain description
of symptoms and
medical history
Presentation
in clinic?
Perform physical examination and diagnostic testing.
BV: Saline wet prep with pH (provider or lab performed)
VVC: KOH wet prep (provider or lab performed)
TV: Saline wet prep (provider or lab performed) with reflex
to Trichomonas vaginalis by Amplified Probe Technique
Yes
Prescribe treatment as
clinically indicated.
No
Schedule office visitYes
No
No
Yes
Yes
Outside guideline scope;
manage as appropriate.
No
Yes
Schedule office visit to perform physical examination
and diagnostic testing.
BV: Gram stain, vaginal
VVC: Vaginal yeast culture with smear
TV: Trichomonas vaginalis by Amplified Probe Technique
Prescribe treatment as
clinically indicated.


BV = bacterial vaginosis; VVC = vulvovaginal candidiasis; TV: Trichomoniasis vaginalis; OTC = over-the-counter






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10


Treatment & Follow-up
Complementary and Alternative Therapies
Complementary and alternative therapies are commonly used to treat vulvovaginal symptoms.1
These may include lactobacillus formulations or probiotics, yogurt, garlic, tea tree oil, a low
carbohydrate diet, or hormonal manipulation with depot medroxyprogesterone.1 Insufficient
evidence exists to consistently evaluate the benefits and harms of these modalities as related to
improving patient outcomes for treatment and symptom relief. For example, some low quality
studies of probiotics have demonstrated safety and efficacy in prevention or treatment of
bacterial vaginosis and vulvovaginal candidiasis, however, additional high quality evidence is
desired prior to routine application by clinicians in practice.5,26-29

Vaginal douching is not recommended.1 (UW Health Very low quality evidence, strong
recommendation) Some studies illustrate an increased risk of vaginal infections with douching,
and no data exists to support the use of douching as treatment or in relief of symptoms.1,30
Bacterial Vaginosis
The established benefits of therapy for bacterial vaginosis include relief of vaginal symptoms
and signs of infection.2 Other potential benefits in symptomatic nonpregnant patients include
reduction in risk for acquiring C. trachomatis, N. gonorrhoeae, T. vaginalis, HIV, and herpes
simple type 2.2

Treatment of Initial Infection
The choice of medication should individualized based on patient preferences, cost, patient
compliance, and any presence of allergies, intolerances, or history of response or adverse
reactions to prior treatments.1 (UW Health Low quality evidence, strong recommendation) Suggested
treatment regimens for symptomatic patients with bacterial vaginosis are outlined in Table 4.2

Clindamycin and metronidazole have been found to be equally effective, achieving clinical cure
rates of 91% and 92% respectively after 2-3 weeks of treatment.5 A comparison of tinidazole
with metronidazole in 593 women with bacterial vaginosis also did not reveal significant
differences in cure rates or side-effect profiles between the two medications.31

Multiple studies and meta-analyses have failed to demonstrate an association between
metronidazole use during pregnancy and teratogenic or mutagenic effects in newborns.2
Symptomatic pregnant patients can be treated with either of the oral or vaginal metronidazole or
clindamycin regimens recommended for non pregnant patients.2 (UW Health Moderate quality
evidence, weak/conditional recommendation) However, tinidazole should be avoided during
pregnancy as animal data suggests this medication poses moderate risk.2(UW Health Very low
quality evidence, strong recommendation)

Alcohol consumption should be avoided during treatment with nitroimidazoles.2 It is
recommended to continue alcohol abstinence 24 hours after completion of metronidazole or 72
hours after completion of tinidazole to reduce the risk for a disulfiram-like reaction.2

Management of Sexual Partners
Patients should be advised to refrain from sexual activity or use condoms consistently and
correctly during the treatment regimen.2 (UW Health Low quality evidence, strong recommendation)
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11


Clindamycin cream and ovules may weaken latex condoms and diaphragms.2 Therefore, use of
these products is not recommended within 72 hours following treatment with clindamycin ovules
or within 5 days following treatment with clindamycin cream.2

Routine prescription of treatment for sexual partners is not recommended.32 (UW Health Moderate
quality evidence, strong recommendation) In several high quality studies, treatment of male sexual
partners with antibiotics, when compared with placebo, did not increase the rate of clinical or
symptomatic improvement of their partner diagnosed with BV.32 Furthermore, antibiotic
treatment of the sexual partner does not appear to demonstrate effect on the recurrence of BV
up to 12 weeks after treatment, but did increase the frequency of minor adverse effects reported
by the sexual partner.32

Follow-up
Follow-up evaluation is unnecessary if symptoms resolve.2 (UW Health Low quality evidence,
strong recommendation) As persistent or recurrent infections are common, patients should be
advised to return for evaluation if symptoms recur.2 (UW Health Low quality evidence, strong
recommendation)

Persistent or Recurrent Infection
Use of oral contraceptives may have a protective affect against BV recurrences, whereas the
following risk factors have been associated with recurrence15:
ξ Sexual activity, specifically with increased numbers of sexual partners, inconsistent condom
use, and women who have sex with women
ξ Vaginal douching
ξ Cigarette smoking
ξ Increased body mass index

Suggested treatment regimens for patients with persistent or recurrent bacterial vaginosis are
outlined in Table 4.2 Detection of certain BV-associated organisms has been associated with
antimicrobial resistance and might be predictive of risk for subsequent treatment failure.2 In
patients with persistent or recurrent BV after the first occurrence, retreatment with the same
recommended regimen is acceptable. (UW Health Low quality evidence, weak/conditional
recommendation)

For patients with multiple recurrences after completion of a recommended regimen, 0.75%
metronidazole gel twice weekly for 4–6 months has been shown to reduce recurrences,
although this benefit might not persist when suppressive therapy is discontinued.2 (UW Health
Low quality evidence, weak/conditional recommendation)

Limited data suggest that an oral nitroimidazole (metronidazole or tinidazole 500 mg twice daily
for 7 days) followed by intravaginal boric acid 600 mg daily for 21 days and then suppressive
0.75% metronidazole gel twice weekly for 4–6 months for those women in remission might be
an option for women with recurrent BV.2 (UW Health Low quality evidence, weak/conditional
recommendation) Monthly oral metronidazole 2 g administered with fluconazole 150 mg has also
been evaluated as suppressive therapy; this regimen reduced the incidence of BV and
promoted colonization with normal vaginal flora.2 (UW Health Low quality evidence, weak/conditional
recommendation)

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12


Trichomoniasis
The benefits of therapy for Trichomoniasis vaginalis include a reduction of symptoms and signs,
and possible reduction in transmission.2 With treatment, the likelihood of adverse outcomes in
patients with HIV is also reduced.2

Treatment of Initial Infection
The choice of medication should individualized based on HIV infection status, patient
preferences, cost, patient compliance, and any presence of allergies, intolerances, or history of
response or adverse reactions to prior treatments.1 (UW Health Low quality evidence, strong
recommendation) Treatment regimens for symptomatic patients with T. vaginalis are outlined in
Table 5.2

Nitroimidazoles are the only class of antimicrobial medications known to be effective against T.
vaginalis infections.2 Tinidazole is generally more expensive, reaches higher levels in serum
and the genitourinary tract, has a longer half-life and has fewer gastrointestinal side effects than
metronidazole.2 Cure rates differ slightly between metronidazole and tinidazole, approximately
84-98% and 92-100% respectively.2

Multiple studies and meta-analyses have failed to demonstrate an association between
metronidazole use during pregnancy and teratogenic or mutagenic effects in newborns.2
Symptomatic pregnant patients can be treated with either of the oral or vaginal metronidazole or
clindamycin regimens recommended for non pregnant patients.2 (UW Health Moderate quality
evidence, weak/conditional recommendation) Tinidazole should be avoided during pregnancy, and
breastfeeding should be deferred for 72 hours following a single 2-g dose.2 (UW Health Very low
quality evidence, strong recommendation)

Alcohol consumption should be avoided during treatment with nitroimidazoles.2,33 It is
recommended to continue alcohol abstinence 24 hours after completion of metronidazole or 72
hours after completion of tinidazole to reduce the risk for a disulfiram-like reaction.2

Management of Sexual Partners
Trichomoniasis is a sexually transmitted infection, requiring treatment of both the patient and
their sexual partner. Patients should be advised to abstain from sexual activity until they and
their sex partners are treated (i.e., when therapy has been completed and any symptoms have
resolved).2 (UW Health Low quality evidence, strong recommendation)

In Wisconsin, expedited partner therapy (EPT) can be given to the patient to provide to any
partner(s) with whom the patient has had sex in the 60 days prior to the onset of symptoms or a
positive test.2,33 (UW Health Low quality evidence, weak/conditional recommendation) Partners with
reported or known severe allergies to antibiotics should not receive EPT.33 (UW Health Low
quality evidence, strong recommendation) The recommended regimen for EPT is metronidazole 2
grams by mouth in a single dose (once).33 (UW Health Low quality evidence, strong recommendation)
Common side effects include dizziness, headache, diarrhea, nausea, stomach pain, and change
in taste sensitivity or dry mouth.33

EPT for Trichomoniasis is not legal in Illinois.34

Follow-up
Due to the high rate of reinfection, retesting for T. vaginalis is recommended for all sexually
active patients within 3 months following initial treatment regardless of whether they believe
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13


their sex partners were treated.2 (UW Health Very low quality evidence, weak/conditional
recommendation)
Testing by nucleic acid amplification can be conducted as soon as 2 weeks after treatment.2,35

Persistent or Recurrent Infection
It is important to consider the cause for persistent or recurrent infections and to distinguish the
possibility of simply reinfection from an untreated sex partner from other causes (e.g.,
antimicrobial resistance, nonadherence to treatment, treatment failure).2,35 (UW Health Low quality
evidence, strong recommendation) Repeat infections are common, ranging from 5-31% in HIV
negative women and 18-37% in HIV positive women.35 Rates of metronidazole resistance is
relatively low (ranging from 2.2-9.6%), and typically resolved with repeat treatment at the same
or higher dosage.35 Treatment failure has been seen in 7-10% of cases (and can be even higher
among HIV positive patients).35 Suggested treatment regimens for truly persistent or recurrent
T. vaginalis are outlined in Table 5.2

Single-dose therapy should be avoided for treating recurrent trichomoniasis that is not likely a
result of reinfection.2 (UW Health Low quality evidence, strong recommendation) If treatment failure
has occurred with metronidazole 2 g single dose and reinfection is excluded, the patient (and
their partner[s]) can be treated with metronidazole 500 mg orally twice daily for 7 days.2 (UW
Health Low quality evidence, weak/conditional recommendation) If this regimen fails, clinicians should
consider treatment with metronidazole or tinidazole at 2 g orally for 7 days.2 (UW Health Low
quality evidence, weak/conditional recommendation)

If several 1-week regimens have failed in a person who is unlikely to have nonadherence or
reinfection, consider nitroimidazole resistance and consult an Infectious Disease specialist.2
(UW Health Low quality evidence, weak/conditional recommendation)
Vulvovaginal candidiasis

Treatment of Initial Infection
The choice of medication should individualized based on patient preferences, cost, patient
compliance, and any presence of allergies, intolerances, or history of response or adverse
reactions to prior treatments.1 (UW Health Low quality evidence, strong recommendation) Factors
Treatment regimens for patients with vulvovaginal candidiasis are outlined in Table 6.2

No statistically significant differences were found in clinical cure rates of anti-fungals
administered by the oral and intravaginal routes.36 However, in April 2016, FDA released a
warning for the use of fluconazole in patients who are pregnant. Therefore, intravaginal creams
and suppositories are recommended in this patient population.2,37 (UW Health Low quality
evidence, weak/conditional recommendation)

Although shorter duration therapy is available and recommended by national guidelines,
avoidance of over-the-counter medications with a shorter duration of therapy is suggested. (UW
Health Very low quality evidence, weak/conditional recommendation) These agents are believed to
cause a greater number of side effects (e.g., burning, irritation) and often do not meet patient
expectations for immediate symptom resolution which can prompt repeated contacts, concern
for reinfection, and overall dissatisfaction.38

Management of Sexual Partners
Uncomplicated vulvovaginal candidiasis is not usually acquired through sexual intercourse,
therefore data does not support treatment of sex partners.2 Patients should be advised that the
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creams and suppositories may weaken latex condoms and diaphragms.2 (UW Health Low quality
evidence, strong recommendation)

Follow-up
Follow-up evaluation is unnecessary if symptoms resolve.2 (UW Health Low quality evidence,
strong recommendation) However, patients should be advised to return for evaluation if symptoms
recur.2 (UW Health Low quality evidence, strong recommendation)

Persistent or Recurrent Infection
Recurrent Vulvovaginal Candidiasis, usually defined as four or more episodes of symptomatic
VVC within 1 year, affects a small percentage of patients (< 5%).2 Suggested treatment
regimens for truly persistent or recurrent T. vaginalis are outlined in Table 6.2

Oral fluconazole (i.e., 100 mg, 150 mg, or 200 mg) weekly for 6 months is the first line
maintenance regimen.2,39 (UW Health Low quality evidence, weak/conditional recommendation)

If recurrence of nonalbicans Candida occurs, 600 mg of boric acid in a gelatin capsule is
recommended, administered vaginally once daily for 2 weeks.2 (UW Health Low quality evidence,
weak/conditional recommendation) This regimen has clinical and mycologic eradication rates of
approximately 70%.2 If symptoms recur, referral to an Infectious Disease specialist is
recommended.2 (UW Health Low quality evidence, weak/conditional recommendation)

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15


Table 4. Treatment of Bacterial Vaginosis2
INITIAL INFECTION
Recommended Regimens Considerations
Metronidazole 500 mg tab orally twice a day for 7 days
0.75% gel, one full applicator (5 g) intravaginally, once a day for 5 days
ξ Preferred first line agent in most patients
ξ Oral route is preferred in pregnant patients
ξ Avoid alcohol1,2
ξ Oral route may be associated with significant gastrointestinal symptoms1
ξ Consider gel if patient does not tolerate oral medications2
Clindamycin 2% cream, one full applicator (5 g) intravaginally at bedtime for 7 days
ξ Preferred in patients with an allergy or intolerance to metronidazole or
tinidazole2
ξ May weaken latex condoms and diaphragms2
Alternative Regimens
Clindamycin 300 mg capsule orally twice daily for 7 days
100 mg ovules intravaginally once at bedtime for 3 days
ξ Ovules may weaken latex condoms and diaphragms; avoid use of products
within 72 hours following treatment2
Tinidazole
2 g tab orally daily for 2 days
1 g tab orally once daily for 5 days
ξ Avoid alcohol2
ξ Avoid during pregnancy2
ξ Lower dose for longer duration may cause less side effects
ξ Typically more expensive than metronidazole
PERSISTENT OR RECURRENT INFECTION
Retreat with same recommended regimen (see above) ξ Acceptable after first occurrence2
Metronidazole 0.75% gel twice weekly for 4-6 months ξ Recommended in patients with multiple recurrences
2

ξ Avoid alcohol2
Metronidazole
or Tinidazole
+
Boric acid
+
Metronidazole
500 mg tab twice daily for 7 days


600 mg intravaginally daily for 21 days

0.75% gel intravaginally twice weekly for 4-6 months
ξ Option for patients with multiple recurrences2
ξ Tinidazole is typically more expensive than metronidazole
ξ Avoid alcohol with use of nitroimidazoles2
ξ Avoid tinidazole during pregnancy2
ξ A specialty pharmacy may need to compound the boric acid
ξ Suppressive therapy may be considered in patients in remission2
Metronidazole
+
Fluconazole
2 g tab orally monthly

150 mg tab orally monthly
ξ Consider use as suppressive therapy2
ξ High dose of metronidazole may cause significant gastrointestinal side effects
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16



Table 5. Treatment of Trichomoniasis vaginalis2,17
INITIAL INFECTION
Recommended Regimens Considerations
Metronidazole

2 g tab orally in a single dose
ξ Preferred first line agent in most patients
ξ Recommended for expedited partner therapy33
ξ Avoid alcohol1,2
ξ Common side effects include dizziness, headache, diarrhea, nausea, stomach pain, and change in
taste sensitivity or dry mouth33
ξ If significant gastrointestinal symptoms, consider 1 g tab orally for 2 doses Q12 hours
Tinidazole 2 g tab orally in a single dose
ξ Available first line agent
ξ More expensive than metronidazole (approximately ten times retail price)17
ξ Slightly higher cure rate than metronidazole
ξ Fewer gastrointestinal side effects than metronidazole
Alternative Regimen
Metronidazole 500 mg tab orally twice a day for 7 days
ξ Preferred for patients with HIV infection2
ξ Lower rates of side effects (nausea and vomiting) than single dose35
ξ Avoid alcohol1,2
PERSISTENT OR RECURRENT INFECTION – EXCLUDE REINFECTION
Metronidazole 500 mg tab orally twice daily for 7 days
ξ Recommended for initial treatment failure of metronidazole 2 g single dose2
ξ Consider for partner therapy
Metronidazole
or Tinidazole
2 g tab orally for 7 days
ξ Option for failure of metronidazole 500 mg tab twice daily for 7 days
Consult Infectious Disease specialist
ξ Consider in cases of suspected nitroimidazole resistance or continued infection







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Table 6. Treatment of Vulvovaginal candidiasis2
INITIAL INFECTION
Recommended Regimens Considerations
Clotrimazole 1% cream 5 g intravaginally daily for 7-14 days
2% cream 5 g intravaginally daily for 3 days
ξ Clotrimazole, miconazole, and tioconazole are available over-the-
counter
ξ Butoconazole and terconazole are only available via prescription
ξ Local side effects (burning, irritation)1
ξ Clotrimazole has best reported tolerance 38
ξ Longer duration therapy is recommended if concerns for patient
expectations or side effects
ξ Immunocompromised patients do not respond as well to short-term
therapies; recommend more prolonged treatment (i.e., 7-14 days)2

Miconazole 2% cream 5 g intravaginally daily for 7 days
100 mg vaginal suppository, one daily for 7 days
200 mg vaginal suppository, one daily for 3 days
Tioconazole 6.5% ointment 5 g intravaginally in a single application
Butoconazole 2% cream 5 g intravaginally in a single application
Terconazole 0.4% cream 5 g intravaginally daily for 7 days
0.8% cream 5 g intravaginally daily for 3 days
80 mg vaginal suppository, one suppository daily for 3 days
Fluconazole 150 mg tab orally in a single dose ξ Avoid in pregnancy (FDA warning)37
ξ Effective in mild or moderately severe VVC, additional doses (max
every 72 hours for 2-3 doses) may be required for severe infections38
ξ Systemic side effects (gastrointestinal intolerance, headache)1,2
ξ Immunocompromised patients do not respond as well to short-term
therapies; recommend more prolonged treatment (i.e., 7-14 days)2
ξ Only available via prescription
PERSISTENT OR RECURRENT INFECTION
Fluconazole 100, 150, 200 mg tab orally each week for 6 months ξ First line maintenance regimen2
Boric acid 600 mg gelatin capsule vaginally once daily for 2 weeks ξ Option for failure of fluconazole tab weekly for 6 months
Consult Infectious Disease specialist ξ Consider in cases of suspected resistance or continued infection
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18


UW Health Implementation
Potential Benefits:
ξ Reduction in practice variation across legacy UWHC and UWMF clinics
ξ Improved patient experience and satisfaction
ξ Reduction in health care costs; more efficient treatment and diagnosis

Potential Harms:
ξ Delay in appropriate treatment/diagnosis if using OTC medication or prescription first
ξ Prenatal or infant exposure to medications if patient pregnant or in postpartum period
ξ Adverse reactions to pharmacotherapy
ξ Psychosocial implications of recurrent disease including distress, embarrassment, lack
of control, or avoidance of daily activities due to fear of others detecting vaginal odor

Pertinent UW Health Policies & Procedures
1. UWHC Policy #13.04: Communicable Disease Reporting

Patient Resources
1. Healthwise- Vaginitis
2. Healthwise- Vaginal Yeast Infections
3. Healthwise- Vaginal Yeast Infections: Should I Treat It Myself?
4. Healthwise- Trichomoniasis

Guideline Metrics
1. % of patients treated first who required diagnostic testing within 2 weeks
2. Frequency of laboratory testing by clinic
3. Rate of orders placed individually vs. in combination

Implementation Plan/Clinical Tools
1. Guideline will be posted on uConnect in a dedicated location for Clinical Practice Guidelines.
2. Release of the guideline will be advertised in the Physician/APP Briefing newsletter.
3. Content and hyperlinks within clinical tools, documents, or Health Link related to the
guideline recommendations (such as the following) will be reviewed for consistency and
modified as appropriate.

Delegation Protocols
Treatment of Sexually Transmitted Infections or Genital Infections – Adult/Pediatric – Ambulatory [27]

Order Sets & Smart Sets
Vaginitis/STD/Pelvic SX [98]
OP – Treatment of Sexually Transmitted Infections (STIs) or Genital Infections Delegation Protocol –
Adult/Pediatric – Ambulatory [5264]

Disclaimer
Clinical practice guidelines assist clinicians by providing a framework for the evaluation and
treatment of patients. This guideline outlines the preferred approach for most patients. It is not
intended to replace a clinician’s judgment or to establish a protocol for all patients. It is
understood that some patients will not fit the clinical condition contemplated by a guideline and
that a guideline will rarely establish the only appropriate approach to a problem.
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19


Appendix A. Evidence Grading Scheme(s)

Figure 2. GRADE Methodology adapted by UW Health


GRADE Ranking of Evidence
High We are confident that the effect in the study reflects the actual effect.
Moderate We are quite confident that the effect in the study is close to the true effect, but it
is also possible it is substantially different.
Low The true effect may differ significantly from the estimate.
Very Low The true effect is likely to be substantially different from the estimated effect.

GRADE Ratings for Recommendations For or Against Practice
Strong The net benefit of the treatment is clear, patient values and circumstances
are unlikely to affect the decision.
Weak/conditional
Recommendation may be conditional upon patient values and
preferences, the resources available, or the setting in which the
intervention will be implemented.






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20


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Copyright © 2017 Univ ersity of Wisconsin Hospitals and Clinics Authority
Contact: Lee Vermeulen, CCKM@uwhealth.org Last Revised: 08/2017CCKM@uwhealth.org