List of Abbreviations
NASBA — Nucleic Acid Sequence-Based Amplification (method for amplification of RNA molecules in a biological sample)
PID — pelvic inflammatory disease
HIV - human immunodeficiency virus
WHO - World Health Organization
DNA - deoxyribonucleic acid
STI — sexually transmitted infection
ELISA - enzyme-linked immunosorbent assay
ICD — International Classification of Diseases
PCR — polymerase chain reaction
RNA - ribonucleic acid
** - drug is included in the VED list
Terms and Definitions
Mycoplasma genitalium is an obligate pathogenic microorganism with tropism for columnar epithelium capable of causing urethritis in both sexes, as well as cervicitis and pelvic inflammatory disease in women.
Mycoplasma hominis, Ureaplasma urealyticum, Ureaplasma parvum are opportunistic microorganisms that, when realizing their pathogenic properties, can cause urethritis, cervicitis, cystitis, as well as pregnancy complications, postpartum and postabortion complications.
1. Brief information on the disease or condition
1.1 Definition of the disease or condition
Urogenital diseases caused by Mycoplasma genitalium — urethritis, cervicitis, pelvic inflammatory disease caused by the obligate pathogen Mycoplasma genitalium.
1.2 Etiology and pathogenesis of the disease or condition (group of diseases or conditions)
Mycoplasmas belong to the kingdom Prokaryotae, phylum Tenericutes, class Mollicutes, order Mycoplasmatales, family Mycoplasmataceae, and are grouped into the genus Mycoplasma.
The distinguishing features of mycoplasmas include: small size of viable particles, close to that of viruses; absence of a rigid cell wall; presence of DNA and RNA in cells; ability to grow on cell-free nutrient media; reproduction by binary fission; cellular polymorphism. Mycoplasmas are the smallest self-replicating prokaryotes.
The morphology and size of mycoplasmas vary depending on the culture age, conditions, and culture media (colony formation on nutrient media takes from 1 to 5 months). The high selectivity and fastidious nature of mycoplasmas regarding nutrient media are explained by the small number of genes involved in the enzymatic breakdown of nutrients required for microorganism replication. The following members of the family Mycoplasmataceae are capable of causing inflammatory diseases of the urogenital tract in men and women:
- strict pathogenic microorganism — Mycoplasma genitalium;
- opportunistic microorganisms: Mycoplasma hominis, Ureaplasma urealyticum, Ureaplasma parvum.
Other representatives of the family Mycoplasmataceae of the genus Mycoplasma (M. pneumoniae, M. fermentans, M. penetrans, M. incognitos, etc.) are capable of infecting the epithelium of the oropharynx, bronchi, and articular surfaces of bones.
Mycoplasma genitalium belongs to motile bacterial species, has a flask shape and an elongated terminal structure used to facilitate gliding motility, penetration into the mucus layers covering epithelial cells, attachment to the cell surface, and entry into cells. The ability of Mycoplasma genitalium to attach to the surface of eukaryotic cells is determined by receptors containing neuraminic acid, which causes a pronounced cytopathic effect and the formation of a cellular inflammatory response. Mycoplasma genitalium is capable of maintaining the viability of host cells even with intranuclear localization of the parasite, which is a distinguishing feature from other bacterial pathogens.
Mycoplasma genitalium exhibits a tropism for columnar epithelium and is capable of affecting the mucous membrane of the urethra, cervical canal, and fallopian tubes. Complications of chronic mycoplasma infection may include: infertility, miscarriage, chorioamnionitis, fetoplacental insufficiency, preterm labor, and postpartum endomyometritis. The etiological role of Mycoplasma genitalium in the development of epididymitis and prostatitis is being discussed, but no convincing evidence on this issue has been obtained to date.
Infection with Mycoplasma genitalium in adults and adolescents occurs sexually, and in children via transplacental, intranatal, and sexual routes. Also, the scientific literature describes the spread of Mycoplasma genitalium via canalicular, lymphogenous, hematogenous routes, and with the participation of spermatozoa.
Unlike Mycoplasma genitalium, other representatives of the family Mycoplasmataceae — Mycoplasma hominis, Ureaplasma urealyticum, Ureaplasma parvum are opportunistic microorganisms. World Health Organization experts (2006) defined Ureaplasma urealyticum as a potential causative agent of nonspecific nongonococcal urethritis in men and, possibly, pelvic inflammatory disease in women. At the same time, experts from the US Centers for Disease Control and Prevention (CDC) do not consider the etiological role of genital mycoplasmas (except for Mycoplasma genitalium) in the development of urogenital inflammatory processes to be proven.
1.3 Epidemiology of the Disease or Condition
According to various researchers, the detection rate of Mycoplasma genitalium in the general population ranges from 1% to 3.3%, and in patients with urogenital inflammatory diseases — from 10% to 45%. Mycoplasma genitalium is detected in 11.5–41.7% of patients with nongonococcal urethritis, in 3–54.5% of patients with nongonococcal nonchlamydial urethritis, and in 7–10% of women with pelvic inflammatory disease [1–4].
1.4 Features of Coding the Disease or Condition
A63.8 — Other specified sexually transmitted diseases.
WHO experts recognized Mycoplasma genitalium as a sexually transmitted infection (STI) pathogen only in 2016, whereas the International Statistical Classification of Diseases and Related Health Problems, Tenth Revision (ICD-10) was approved by the WHO much earlier. Therefore, for statistical recording of urogenital diseases caused by Mycoplasma genitalium, it is currently possible to use the ICD-10 code "A63.8 Other specified sexually transmitted diseases" with the subsequent specification of the topical diagnosis presented in the relevant sections of ICD-10:
Urethritis caused by Mycoplasma genitalium
Cervicitis caused by Mycoplasma genitalium
Salpingo-oophoritis caused by Mycoplasma genitalium
Endometritis caused by Mycoplasma genitalium
1.5 Classification of the disease or condition
There is no universally accepted clinical classification.
1.6 Clinical presentation of the disease or condition
Monoinfection with Mycoplasma genitalium in the vast majority of cases proceeds with mild symptoms or is asymptomatic.
Urethritis caused by Mycoplasma genitalium
Objective symptoms in the acute course of the inflammatory process: hyperemia and edema of the mucous membrane of the external urethral orifice, infiltration of the urethral walls, mucopurulent or mucous discharge from the urethra [1, 5, 6].
Cervicitis caused by Mycoplasma genitalium
Objective symptoms in the acute course of the inflammatory process: edema and hyperemia of the cervical mucosa, mucopurulent discharge from the cervical canal, erosions of the cervical mucosa [4, 6, 7].
Salpingo-oophoritis caused by Mycoplasma genitalium
In the acute course of the inflammatory process — enlarged, painful fallopian tubes and ovaries on palpation, shortening of the vaginal fornices, mucopurulent discharge from the cervical canal; in the chronic course of the disease — slight tenderness, induration of the fallopian tubes [8, 9].
Endometritis caused by Mycoplasma genitalium
In the acute course of the inflammatory process — painful, enlarged uterus of soft consistency, mucopurulent discharge from the cervical canal; in the chronic course of the disease — dense consistency and restricted mobility of the uterus [2, 9].
2. Diagnostics, medical indications and contraindications for diagnostic methods
Diagnostic criteria
The diagnosis of diseases caused by Mycoplasma genitalium is established on the basis of detecting the pathogen's DNA and/or RNA in biological material using molecular biological laboratory methods.
2.1 Complaints and Anamnesis
Urethritis caused by Mycoplasma genitalium
In the acute course of the inflammatory process, the following subjective symptoms may occur: scanty mucopurulent or mucous discharge from the urethra; itching, burning, pain during urination (dysuria); discomfort, itching, burning in the urethra; pain during sexual intercourse (dyspareunia); frequent urination and urgent urinary urges (with proximal spread of the inflammatory process) [1, 5, 6].
Cervicitis caused by Mycoplasma genitalium
In the acute course of the inflammatory process, the following subjective symptoms may occur: acyclic spotting, pain during sexual intercourse (dyspareunia), discomfort or pain in the lower abdomen [4, 6, 7].
Salpingo-oophoritis caused by Mycoplasma genitalium
In the acute course of the inflammatory process — cramping lower abdominal pain, mucopurulent vaginal discharge; in the chronic course of the disease, subjective manifestations are less pronounced, menstrual irregularities are noted [8, 9].
Endometritis caused by Mycoplasma genitalium
In the acute course of the inflammatory process — lower abdominal pain, usually aching in nature, mucopurulent vaginal discharge; in the chronic course of the disease, subjective manifestations are less pronounced, and acyclic intermenstrual uterine bleeding is often noted [2, 9].
2.2 Physical Examination
It is recommended to inspect the skin and visible mucous membranes of the external genitalia; assess the condition of the mucous membrane of the external urethral orifice, presence of free urethral discharge and its character, palpate the urethra and regional lymph nodes; in sexually active females, examine the vaginal vestibule with palpation of the vestibular gland area, examine the mucous membranes of the vaginal walls and fornices, and the visible part of the cervix using a vaginal speculum; evaluate discharge in the posterior and posterolateral vaginal fornices and from the cervical canal; perform a bimanual vagino-abdominal examination, palpation of the scrotal contents, and digital rectal examination (as indicated) [12, 14].
LoR CGoE 5Level of Recommendation C (Grade of Evidence - 5)
For objective clinical manifestations of the disease identified during physical examination, see the "Clinical Presentation" section.
2.3 Laboratory Diagnostics
It is recommended for the diagnosis of urogenital diseases caused by Mycoplasma genitalium, to obtain biological material (scrape) from the urethra in men, and from the urethra and cervical canal in women [12, 13].
LoR CGoE 5Level of Recommendation C (Grade of Evidence - 5)
It is recommended to use molecular biological methods (PCR, real-time PCR) to verify the diagnosis of urogenital diseases caused by Mycoplasma genitalium in adults and children: molecular biological testing of female genital mucous membrane discharge for (Mycoplasma genitalium) and/or molecular biological testing of semen for (Mycoplasma genitalium) and/or molecular biological testing of urethral discharge for sexually transmitted infection pathogens (Neisseria gonorrhoeae, Trichomonas vaginalis, Chlamydia trachomatis, Mycoplasma genitalium) and/or molecular biological testing of prostatic secretion for (Mycoplasma genitalium) [10, 11, 14, 15, 22, 61].
For adults — strength of recommendation C (evidence level — 4)
For children — strength of recommendation C (level of evidence — 5)
Comments:
The sensitivity of the methods is 98–100%, and the specificity is 100%. To obtain reliable laboratory test results, a number of requirements must be met, including:
- collection of clinical material from the urethra no earlier than 3 hours after the last urination; in the presence of profuse urethral discharge, 15-20 minutes after urination;
- obtaining clinical material from the cervical canal before menstruation or 2 days after its cessation;
- obtaining clinical material from the cervical canal no earlier than 24–48 hours after transvaginal ultrasound examination and colposcopy;
- excluding vaginal douching on the eve of the examination and on the day it is performed;
- exclusion of genital hygiene procedures using intimate hygiene products on the day of the examination;
- obtaining clinical material for PCR and real-time PCR testing no earlier than one month after the completion of therapy with drugs active against Mycoplasma genitalium;
- compliance with the conditions for transporting clinical samples to the laboratory.
In cases of pronounced clinical manifestations of urethritis, the first portion of urine can be used as clinical material for molecular biological diagnostics (bladder emptying must be no later than 2 hours before collecting the first portion of urine).
Obtaining and examining a rectal scraping to identify Mycoplasma genitalium is indicated only in symptomatic proctitis after excluding N. gonorrhoeae and C. trachomatis as pathogens. Obtaining and examining oropharyngeal scrapings is not recommended [12].
It is not recommended in adults and children to use other laboratory diagnostic methods for urogenital diseases caused by Mycoplasma genitalium, including culture methods, direct immunofluorescence assays, and enzyme-linked immunosorbent assay (ELISA) for the detection of antibodies to Mycoplasma genitalium [12, 13, 15, 22].
LoR CGoE 5Level of Recommendation C (Grade of Evidence - 5)
It is not recommended in adults and children to use biological, chemical, and alimentary provocations to increase the diagnostic and treatment efficacy of urogenital diseases caused by Mycoplasma genitalium [12, 13].
LoR CGoE 5Level of Recommendation C (Grade of Evidence - 5)
Comments:
Due to shared routes of transmission for STIs and HIV infection, patients with urogenital diseases caused by Mycoplasma genitalium should undergo:
- laboratory tests for other STIs: syphilis (detection of antibodies to Treponema pallidum in nontreponemal tests (RPR, VDRL) (qualitative and semi-quantitative test) in blood serum and/or detection of antibodies to Treponema pallidum by enzyme immunoassay (EIA)), gonococcal infection, chlamydial infection, urogenital trichomoniasis;
- determination of human immunodeficiency virus HIV-1 antibodies classes M, G (IgM, IgG) in the blood. Determination of human immunodeficiency virus HIV-2 antibodies classes M, G (IgM, IgG) in the blood;
- determination of hepatitis B virus surface antigen (HbsAg) in the blood;
- determination of total antibodies classes M and G (anti-HCV IgG and anti-HCV IgM) to hepatitis C virus in the blood [7, 15–19].
Screening for opportunistic Ureaplasma and/or Mycoplasma hominis is performed if the patient has clinical and/or laboratory signs of an inflammatory process in the urogenital tract and reproductive system and/or dysbiotic disorders of the vaginal microflora in the absence of primary pathogens. In the absence of clinical and/or laboratory signs of inflammation, screening for Ureaplasma and/or M. hominis is performed in: sperm donors; patients diagnosed with infertility; patients with a history of recurrent pregnancy loss and perinatal losses. Identification of Ureaplasma and/or M. hominis is carried out using molecular biological methods aimed at detecting specific DNA fragments of microorganisms, and/or based on the results of culture studies. Microscopic examination is performed to assess the degree of leukocytic response and the state of microbiocenosis of the urethra, vagina, and cervical canal. The clinical utility and significance of quantitative determination of genital mycoplasmas have not been convincingly proven [13–16].
2.4 Instrumental Diagnostics
It is recommended to refer adults and children for a comprehensive pelvic ultrasound examination if it is necessary to rule out pelvic inflammatory disease caused by Mycoplasma genitalium [2, 9, 13].
LoR CGoE 5Level of Recommendation C (Grade of Evidence - 5)
2.5 Other Procedures
It is recommended to have an initial consultation (examination) with an obstetrician-gynecologist to rule out pelvic inflammatory disease in women, as well as to manage pregnant and lactating women with diseases caused by Mycoplasma genitalium [2, 9, 13].
LoR CGoE 5Level of Recommendation C (Grade of Evidence - 5)
It is recommended to have an initial consultation (examination) with a urologist to diagnose potential reproductive system complications in men [17, 18].
LoR CGoE 5Level of Recommendation C (Grade of Evidence - 5)
3. Treatment, including drug and non-drug therapies, diet therapy, and pain management
Indications for therapy
Identification of Mycoplasma genitalium DNA and/or RNA in biological material.
Treatment goals [19–21]:
- eradication of Mycoplasma genitalium;
- clinical recovery;
- prevention of complications;
- prevention of transmission to others.
3.1. Conservative management
It is recommended to prescribe the following oral medications for adults to treat urethritis and cervicitis caused by Mycoplasma genitalium, with the goal of eradicating Mycoplasma genitalium:
doxycycline** 100 mg twice daily for 7 days, followed by azithromycin** 1 g single initial dose, then 500 mg once daily for 3 days (total azithromycin** dose 2.5 g) [23–26]
LeveL of Recommendation BGrade of Evidence 2LeveL of Recommendation B (Grade of Evidence - 2)
Comments: Doxycycline** in tablet form (active ingredient: doxycycline monohydrate) is preferred due to its better tolerability. When using doxycycline** alone, cure rates are observed in 30–40% of patients.
or
doxycycline** 100 mg twice daily for 7 days, then
moxifloxacin** orally 400 mg once daily for 7 days [12, 34, 26, 34, 35]
GCR CLEL 4Grade of Recommendation C (Level of Evidence - 4)
Comments: This regimen is recommended when macrolide therapy fails. The natural resistance of mycoplasmas to beta-lactam antibacterial drugs and penicillins is due to the absence of peptidoglycan in these bacteria, i.e., it is characterized by the absence of a target for systemic antibacterial drug action.
Resistance of Mycoplasma genitalium to 15-membered macrolides (azithromycin**) is associated with point mutations at position A2058 or A2059 (Escherichia coli numbering) located in the peptidyl transferase center in domain V of 23S rRNA [31, 36]. The A2059G mutation may be associated not only with resistance of Mycoplasma genitalium to 15-membered (azithromycin**), but also to 16-membered macrolides, including position A2062 [37]. Currently, the rate of macrolide resistance in Mycoplasma genitalium varies significantly, ranging from 20% to 82.4% [38–40].
Resistance of Mycoplasma genitalium to fluoroquinolones is caused by alterations in topoisomerase enzymes in the QRDR region of the parC gene at residues S83 and D87, as well as mutations in the gyrA and gyrB genes. A particular challenge in recent years has been the emergence of multi-resistant strains of Mycoplasma genitalium, the proportion of which, according to recent studies, ranges from 2.7% to 4.9% of isolated strains [38–41].
It is recommended to prescribe the following oral medications for adults to treat salpingo-oophoritis and endometritis caused by Mycoplasma genitalium, with the goal of eradicating Mycoplasma genitalium [31, 42, 43–45]:
doxycycline** 100 mg twice daily for 14–21 days
LeveL of Recommendation BGrade of Evidence 2LeveL of Recommendation B (Grade of Evidence - 2)
or
moxifloxacin** 400 mg once daily for 14–21 days
GCR CLEL 5Grade of Recommendation C (Level of Evidence - 5)
Comments: The duration of the course of therapy depends on the severity of clinical manifestations of urogenital inflammatory processes, the results of laboratory and instrumental examinations, the risk assessment of upcoming surgical or invasive procedures, obstetric and gynecological history, and, in pregnant women, the course of the current pregnancy. Depending on the above factors, as well as the response to the ongoing antibiotic therapy (clinical parameters, and if necessary, the result of an interim real-time PCR test), the duration of treatment may be extended up to 21 days.
Systemic enzyme therapy, immunomodulatory therapy, and treatment with local antiseptics and disinfectants are not performed.
It is recommended to prescribe macrolide antibiotics for the treatment of pregnant women and children for the eradication of Mycoplasma genitalium [15, 50, 62, 63, 64, 65]
GCR CLEL 5Grade of Recommendation C (Level of Evidence - 5)
Comments: Treatment of pregnant women is carried out at any stage of pregnancy with antibacterial drugs, taking into account their effect on the fetus, involving obstetriciangynecologists. Erythromycin may be prescribed at 500 mg 4 times a day for 7 days or 500 mg 2 times a day for 14 days [50].
Treatment in children is carried out in accordance with adult dosing regimens, depending on age and body weight, and taking into account contraindications [52, 53].
3.2. Surgical treatment
Not applicable.
3.3. Other treatment
Diet therapy is not used. Analgesia is not used.
4. Medical Rehabilitation and Sanatorium-Resort Treatment
Rehabilitation is not used.
5. Prevention and Dispensary Observation
- early detection of Mycoplasma genitalium through screening of sexually active women aged 25 years and younger and men aged 30 years and younger, individuals at risk of STI acquisition (sex workers, sexually active adolescents, etc.), and couples preparing for pregnancy;
- informing the public about the transmission routes of Mycoplasma genitalium and its consequences for reproductive health;
- use of condoms or avoidance of all forms of casual sexual contact;
- screening and treatment of sexual partners.
6. Organization of Medical Care
Treatment is primarily provided on an outpatient basis in a dermatovenereology healthcare facility, and for pregnant women, in an obstetric and gynecological healthcare facility.
Indications for hospitalization and inpatient treatment include a complicated course of the infectious process caused by Mycoplasma genitalium (moderate to severe pelvic inflammatory disease).
Cure assessment for urogenital diseases caused by Mycoplasma genitalium is performed based on PCR and real-time PCR test results no earlier than one month after the completion of antibiotic therapy, and by the NASBA method no earlier than 2 weeks after the completion of antibiotic therapy.
Patients with negative test results do not require further follow-up.
In the absence of a therapeutic effect, it is recommended to rule out reinfection and prescribe a systemic antibacterial drug from another pharmacological group [13, 14].
LoR CGoE 5Level of Recommendation C (Grade of Evidence - 5)
7. Additional Information
Treatment outcomes are affected by adherence to the antibiotic regimen, the use of barrier contraception during therapy and until cure is confirmed, the avoidance of all forms of casual sexual contact, and the treatment of sexual partners.
Criteria for Evaluating the Quality of Medical Care
№ | Quality criteria | Performance evaluation |
|---|---|---|
1 | Confirmation of the diagnosis by molecular biological testing methods | Yes/No |
2 | Prescription of doxycycline** and azithromycin**, or doxycycline and moxifloxacin**, for urethritis and/or cervicitis caused by Mycoplasma genitalium | Yes/No |
3 | Prescription of doxycycline** or moxifloxacin** for salpingo-oophoritis and/or endometritis caused by Mycoplasma genitalium | Yes/No |
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Appendix A1. Working Group Composition
Alexey Alexeevich Kubanov - Academician of the Russian Academy of Sciences, Doctor of Medical Sciences, Professor, Director of the State Research Center of Dermatovenereology and Cosmetology of the Russian Ministry of Health, President of the Russian Society of Dermatovenereologists and Cosmetologists.
Serov Vladimir Nikolaevich – Academician of the RAS, Doctor of Medical Sciences, Professor, President of the Russian Society of Obstetricians and Gynecologists.
Margarita Rafikovna Rakhmatulina - Doctor of Medical Sciences, Professor, Deputy Director for Organizational and Analytical Work at the State Research Center of Dermatovenereology and Cosmetology of the Russian Ministry of Health, Chair of the Executive Committee of the Russian Society of Dermatovenereologists and Cosmetologists.
Inna Anatolyevna Apolikhina - Doctor of Medical Sciences, Professor, Head of the Department of Aesthetic Gynecology and Rehabilitation at the Kulakov National Medical Research Center for Obstetrics, Gynecology and Perinatology of the Russian Ministry of Health, Member of the Russian Society of Obstetricians and Gynecologists.
Mikhail Alexandrovich Gomberg - Doctor of Medical Sciences, Professor, Chief Researcher at the Moscow Scientific and Practical Center of Dermatovenereology and Cosmetology of the Moscow Healthcare Department, Member of the National Alliance of Dermatovenereologists and Cosmetologists Union.
Gorbunova Elena Alekseevna – Obstetrician-Gynecologist, Researcher at the Department of Aesthetic Gynecology and Rehabilitation, National Medical Research Center for Obstetrics, Gynecology and Perinatology named after Academician V.I. Kulakov of the Russian Ministry of Health, Member of the Russian Society of Obstetricians and Gynecologists.
Dolgushina Nataliya Vitalievna – Doctor of Medical Sciences, Professor, Deputy Director for Research, National Medical Research Center for Obstetrics, Gynecology and Perinatology named after Academician V.I. Kulakov of the Russian Ministry of Health, Member of the Russian Society of Obstetricians and Gynecologists.
Katunin Georgiy Leonidovich – Candidate of Medical Sciences, Dermatovenereologist, State Research Center of Dermatovenereology and Cosmetology of the Russian Ministry of Health, Member of the Russian Society of Dermatovenereologists and Cosmetologists.
Malova Irina Olegovna – Doctor of Medical Sciences, Professor, Professor of the Department of Dermatovenereology, Irkutsk State Medical University, Member of the Russian Society of Dermatovenereologists and Cosmetologists.
Irina A. Nechaeva - Candidate of Medical Sciences, Dermatovenereologist at the State Research Center of Dermatovenereology and Cosmetology of the Russian Ministry of Health, member of the Russian Society of Dermatovenereologists and Cosmetologists.
Onipchenko Viktoriya Viktorovna – Chief Physician of the Novosibirsk Regional Clinical Dermatovenereological Dispensary, Chief Specialist in Dermatovenereology and Cosmetology of the Novosibirsk Region, Member of the Russian Society of Dermatovenereologists and Cosmetologists.
Plakhova Ksenia Ilyinichna - Doctor of Medical Sciences, Scientific Secretary, Acting Head of the STI Department, State Research Center of Dermatovenereology and Cosmetology of the Russian Ministry of Health, member of the Russian Society of Dermatovenerologists and Cosmetologists.
Potekaev Nikolay Nikolaevich - Doctor of Medical Sciences, Professor, Director of the Moscow Scientific and Practical Center of Dermatovenereology and Cosmetology of the Moscow Healthcare Department, Chief freelance specialist in dermatovenereology and cosmetology of the Russian Ministry of Health, President of the National Alliance of Dermatovenerologists and Cosmetologists Union.
Prilepskaya Vera Nikolaevna – Doctor of Medical Sciences, Professor, Honored Scientist of the Russian Federation, Deputy Director for Research, Head of the Scientific and Policlinic Department, National Medical Research Center for Obstetrics, Gynecology and Perinatology named after Academician V.I. Kulakov of the Russian Ministry of Health, Member of the Russian Society of Obstetricians and Gynecologists.
Priputnevich Tatyana Valerievna – Doctor of Medical Sciences, Director of the Institute of Microbiology, Antimicrobial Therapy and Epidemiology, National Medical Research Center for Obstetrics, Gynecology and Perinatology named after Academician V.I. Kulakov of the Russian Ministry of Health, Member of the Russian Society of Obstetricians and Gynecologists.
Tatyana A. Sysoeva - Candidate of Medical Sciences, Associate Professor at the Department of Dermatovenereology and Cosmetology, Russian Medical Academy of Continuing Professional Education, member of the Russian Society of Dermatovenereologists and Cosmetologists.
Uvarova Elena Vitalievna – Corresponding Member of the RAS, Doctor of Medical Sciences, Professor, Head of the 2nd Gynecological Department, National Medical Research Center for Obstetrics, Gynecology and Perinatology named after Academician V.I. Kulakov of the Russian Ministry of Health, Member of the Russian Society of Obstetricians and Gynecologists.
Chikin Vadim Viktorovich - Doctor of Medical Sciences, Senior Researcher at the Department of Dermatology, State Research Center of Dermatovenereology and Cosmetology of the Russian Ministry of Health, member of the Russian Society of Dermatovenerologists and Cosmetologists.
Khryanin Aleksey Alekseevich – Doctor of Medical Sciences, Professor of the Department of Dermatovenereology and Cosmetology, Novosibirsk State Medical University of the Russian Ministry of Health, Member of the Russian Society of Dermatovenereologists and Cosmetologists.
Shabanova Natalya Evgenievna – Candidate of Medical Sciences, Associate Professor, Head of the Department of Clinical Pharmacology of Antimicrobial and Immunobiological Drugs, Institute of Microbiology, Antimicrobial Therapy and Epidemiology, National Medical Research Center for Obstetrics, Gynecology and Perinatology named after Academician V.I. Kulakov of the Russian Ministry of Health, Member of the Russian Society of Obstetricians and Gynecologists.
Conflict of interest: The authors declare no conflict of interest.
Appendix A2. Methodology for Developing Clinical Guidelines
Target audience for these clinical guidelines:
Specialist physicians: dermatovenereologists, obstetrician-gynecologists, urologists, pediatricians.
Residents and trainees of continuing professional education programs in the specified specialty.
Table 1. Levels of Evidence (LoE) grading scale for diagnostic methods (diagnostic interventions)
LoE | Definition |
|---|---|
1 | Systematic reviews of studies with reference standard control or systematic reviews of randomized controlled trials with meta-analysis |
2 | Individual studies with reference standard control or individual randomized controlled trials and systematic reviews of studies of any design, except randomized controlled trials, with meta-analysis |
3 | Studies without consecutive reference standard control or studies with a reference standard not independent of the test method, or non-randomized comparative studies, including cohort studies |
4 | Non-comparative studies, case report |
5 | Only justification of mechanism of action or expert opinion is available |
Table 2. Scale for grading levels of evidence certainty (LEC) for prevention, treatment, and rehabilitation methods (preventive, therapeutic, and rehabilitative interventions)
LoE | Definition |
|---|---|
1 | Systematic review of RCTs with meta-analysis |
2 | Individual RCTs and systematic reviews of studies of any design except RCTs, with meta-analysis |
3 | Non-randomized comparative studies, including cohort studies |
4 | Non-comparative studies, case reports or case series, case-control studies |
5 | Only a justification of the mechanism of action of the intervention (preclinical studies) or expert opinions are available |
Table 3. Scale for grading grades of recommendation (GR) for prevention, diagnostic, treatment, and rehabilitation methods (preventive, diagnostic, therapeutic, and rehabilitative interventions)
GoR | Definition |
|---|---|
A | Strong recommendation (all considered efficacy criteria (outcomes) are important, all studies are of high or acceptable methodological quality, and their conclusions on the outcomes of interest are consistent) |
B | Conditional recommendation (not all considered efficacy criteria (outcomes) are important, not all studies are of high or acceptable methodological quality, and/or their conclusions on the outcomes of interest are inconsistent) |
C | Weak recommendation (lack of adequate quality evidence (all considered efficacy criteria (outcomes) are unimportant, all studies are of low methodological quality, and their conclusions on the outcomes of interest are inconsistent) |
Procedure for updating clinical guidelines.
The guideline update mechanism provides for their systematic revision at least once every three years, as well as upon the emergence of new evidence-based medicine data regarding the diagnosis, treatment, prevention, and rehabilitation of specific diseases, or in the presence of justified additions/comments to previously approved clinical guidelines, but no more frequently than once every 6 months.
Appendix A3. Reference Materials
No information available
Appendix B. Physician Action Algorithms
Flowchart 1. Patient Management Algorithm
Appendix C. Patient Information
1. To prevent Mycoplasma genitalium infection, the following are necessary:
- use of condoms or avoidance of all forms of casual sexual contact (oral, vaginal, anal);
- abstaining from any forms of sexual contact with individuals who have symptoms of sexually transmitted infections (genital discharge with an unpleasant odor and color, rashes or ulcerations on the external genitalia).
2. Testing for Mycoplasma genitalium is recommended for all sexually active women under 25 years of age and men under 30 years of age, individuals of both sexes at risk of sexually transmitted infections (sex workers, sexually active adolescents, etc.), and couples preparing for pregnancy.
3. Antiseptics, disinfectants, or systemic antibacterial drugs are recommended for emergency prophylaxis of sexually transmitted infections no later than 2 hours after unprotected sexual contact with a potential patient.
4. To prevent reinfection with Mycoplasma genitalium, examination and treatment of sexual partners are required.
5. During treatment and until cure is confirmed, sexual contact should be avoided or barrier contraception methods used.
6. To confirm cure, a follow-up visit to the physician for examination is required one month after completion of treatment.
7. In case of Mycoplasma genitalium infection, screening for other sexually transmitted infections, HIV infection, and hepatitis B and C is recommended.
8. If the source of infection is unidentified, repeat serological testing for syphilis is recommended after 3 months, and for HIV infection, hepatitis B and C, after 3, 6, and 9 months.
Appendix G. Assessment Scales, Questionnaires, and Other Evaluation Tools
Not used.