List of Abbreviations
GnRH agonists — gonadotropin-releasing hormone agonists – per ATC - Gonadotropin-releasing hormone analogues
AUB – abnormal uterine bleeding
LNG-IUS – levonorgestrel-releasing intrauterine system
MHT — menopausal hormone therapy
ICD-10 — International Statistical Classification of Diseases and Related Health Problems 10th Revision
MRI — magnetic resonance imaging
NSAIDs — non-steroidal anti-inflammatory drugs (ATC non-steroidal anti-inflammatory and antirheumatic products)
US — ultrasound
MR-HIFU – magnetic resonance-guided focused ultrasound ablation – per NOMC - Ablation of female genital organs neoplasms
COX-2 – cyclooxygenase-2
UAE — uterine artery embolization for uterine neoplasms
MRgFUS — magnetic resonance-guided focused ultrasound ablation (FUS ablation) – per NOMC - Magnetic resonance-guided focused ultrasound ablation of uterine neoplasms
Terms and Definitions
Uterine fibroids – benign monoclonal tumor originating from smooth muscle cells of the cervix or corpus uteri [1], [2], [3], [4].
1. Brief information on the disease or condition
1.1 Definition of the disease or condition
Uterine fibroids – benign monoclonal tumor originating from smooth muscle cells of the cervix or corpus uteri [1], [2], [3], [4].
1.2 Etiology and pathogenesis of the disease or condition (group of diseases or conditions)
Estrogens and progesterone are traditionally viewed as leiomyoma growth stimulators, which is confirmed by significantly higher expression of estrogen receptors, estrogen-regulated genes, and even more so, progesterone receptor expression (isoforms A and B) compared to the myometrium and endometrium [5].
The genetic nature of this disease is confirmed by the presence of "familial forms" of uterine fibroids in 5-10% of women, while it has been proven that uterine fibroids are monoclonal tumors [6], i.e., their growth originates from a single primary mutant cell that acquires the capacity for unregulated growth. The most significant contribution to the pathogenesis of uterine fibroids is made by chromosomal rearrangements associated with increased expression of the HMGA2 gene [7], [8], as well as somatic mutations in exon 2 of the MED12 gene encoding RNA polymerase II [9], [10].
A significant contribution to the pathogenesis of uterine fibroids is also made by the process of forming new blood vessels from existing ones – neoangiogenesis [1], [11], [12].
Growth factors also play a key role in the development of uterine fibroids. The main growth factors involved in the pathogenesis of uterine fibroids are insulin-like growth factors (IGF), vascular endothelial growth factor (VEGF), hypoxia-inducible factor (HIF), fibroblast growth factor, platelet-derived growth factor, angiogenin, epidermal growth factor, nitric oxide, interleukin-8, and matrix metalloproteinases (MMPs). All these factors form a complex interaction system and activation cascades that play a key role in the molecular pathogenesis of leiomyoma [11], [12], [13], [14].
Risk factors associated with the development of uterine fibroids include a family history, early menarche, nulliparity, the perimenopausal period, obesity, and an increased interval since the last childbirth [11], [12], [14], [15], [16], [17].
1.3 Epidemiology of the Disease or Condition
Uterine fibroids are the most common benign tumors of the female reproductive system [18]. The prevalence of the disease among women of reproductive age reaches 70% [12], [19], [20], [21], [22], [23]. The average age of detection for uterine fibroids is 32–34 years, with the peak incidence occurring at the onset of menopause [23]. Currently, there is an increase in the incidence of uterine fibroids in young women under 30 who have not yet realized their reproductive function [12], [21].
In the majority of women, the disease is asymptomatic, which complicates the assessment of its true prevalence. In 25% of patients of reproductive age, there are clinical manifestations that require treatment. In primary and secondary infertility, uterine fibroids are detected in 23.5% of cases [12], [19], [24]. In some cases, uterine fibroids do not prevent pregnancy and fetal development, but they increase the rate of pregnancy and childbirth complications [25].
1.4 Features of Coding the Disease or Condition
D25.0 – Submucous leiomyoma of uterus;
D25.1 – Intramural leiomyoma of uterus;
D25.2 – Subserosal leiomyoma of uterus;
D25.9 – Leiomyoma of uterus, unspecified.
Other benign neoplasms of uterus (D26):
D26.0 – Benign neoplasm of cervix uteri;
D26.1 – Benign neoplasm of corpus uteri;
D26.7 – Benign neoplasm of other parts of uterus;
D26.9 – Benign neoplasm of uterus, part unspecified;
Maternal care for established or suspected abnormality of pelvic organs (O34):
O34.1 – Maternal care for tumor of corpus uteri.
Neoplasms of uncertain or unknown behavior of female genital organs (D39): D39.0 – Neoplasm of uncertain or unknown behavior of uterus.
1.5 Classification of the disease or condition
· Classification of uterine fibroids by the International Federation of Gynecology and Obstetrics (FIGO), 2011, 2018 [26], [27]:
1.6 Clinical presentation of the disease or condition
See section "History and Symptoms".
2. Diagnostics, medical indications and contraindications for diagnostic methods
The diagnosis of uterine fibroids is established based on complaints, medical history, physical examination, comprehensive pelvic ultrasound (transvaginal and transabdominal), and pelvic MRI (as indicated) [3], [4], [18], [28].
2.1 Complaints and Anamnesis
The course of uterine fibroids can be asymptomatic or symptomatic. Symptoms of the disease include abnormal uterine bleeding, lower abdominal pain of various types and intensities, painful and heavy menstrual periods, infertility in the absence of other causes, miscarriage, dysfunction of adjacent organs (dysuric disorders, constipation), dyspareunia, etc. [3], [4].
Prior to examining patients under the age of 18, it is necessary to obtain informed voluntary consent in the manner and form approved by Order of the Russian Ministry of Health No. 1051n dated November 12, 2021, “On Approval of the Procedure for Giving Informed Voluntary Consent to Medical Intervention and Refusal of Medical Intervention Regarding Certain Types of Medical Interventions, Forms of Informed Voluntary Consent to Medical Intervention and Forms of Refusal of Medical Intervention,” from the patient who has reached the age of 15 years or older, or from a parent (other legal representative) for a patient under the age of 15 (or a drug-addicted patient under 16, or a patient declared legally incompetent at the age from menarche to 17 years inclusively, if such a minor is unable by her condition to give consent for medical intervention).
2.2 Physical Examination
It is recommended to perform a visual inspection of the external genitalia, speculum examination of the cervix, and bimanual pelvic examination in all patients to establish a diagnosis [3], [22], [29].
Level CLevel 5Level of recommendation evidence C (reliability level of evidence – 5).
Comments: Bimanual pelvic examination includes determining the size of the uterus, its mobility, tenderness, and relationship with other pelvic organs; identifying myoma nodes and their location. Uterine size is measured in weeks (corresponding to pregnancy) [22].
In case of cervical-isthmic localization of the myoma node, the cervix is smoothed out, located asymmetrically, and displaced toward the pelvic wall opposite to the node location.
2.3 Laboratory Diagnostics
It is recommended to perform laboratory monitoring in all patients with uterine fibroids to identify complications, conduct a preoperative examination, and determine the tactics of conservative treatment [8], [22].
Level CLevel 5Level of recommendation evidence C (reliability level of evidence – 5).
Comments: Performing a general (clinical) blood count, general therapeutic biochemical blood test, and coagulogram (approximate assessment of the hemostatic system) is carried out to identify complications (anemia, impaired blood circulation in the node, etc.), for preoperative examination, and to determine conservative treatment tactics [22][1].
In adolescents and women with no history of sexual contact, a bimanual recto-abdominal examination of the uterus and appendages is performed. If visualization of the cervix is necessary, a Sims vaginal speculum or Cusco gynecological speculum is used, or vaginoscopy is performed.
[1] Order of the Ministry of Health of the Russian Federation No. 1130n dated October 20, 2020, “On Approval of the Procedure for Providing Medical Care in the Field of ‘Obstetrics and Gynecology (Excluding Assisted Reproductive Technologies)’” (with amendments and additions).
2.4 Instrumental Diagnostics
It is recommended to perform a comprehensive pelvic ultrasound (transvaginal and transabdominal) as the primary screening and initial diagnostic method for uterine fibroids [30], [31], [32], [33], [34], [35], [36].
Level CLevel 5Level of recommendation evidence C (reliability level of evidence – 5).
Comments: Comprehensive pelvic ultrasound (transvaginal and transabdominal) is the primary screening method for uterine fibroids, dynamic monitoring of disease progression, and assessment of the efficacy of various therapeutic modalities (conservative and/or surgical). The method provides the ability for topical diagnosis of myoma nodes, their structure, hemodynamics, and accordingly, the severity of proliferative processes, differential diagnosis (adenomyosis, sarcoma, etc.), and detection of secondary changes in nodes resulting from circulatory disorders (necrosis, edema, hyalinosis) [32], [33]. Modern 3/4D technologies provide additional information on the localization of fibroid nodes, which is particularly important in their centripetal growth and submucosal location. Color Doppler mapping is used to assess the structure of the myoma node [30], [34]. In some cases, echohysterosalpingography and hysterosalpingography may be used – according to the medical services nomenclature (Hysterography) [26].
Comments: In 40% of cases, uterine fibroids are combined with adenomyosis [33], [36].
It is recommended to perform hysteroscopy in patients with suspected intramural-submucous and submucous localization of myoma nodes, to rule out intrauterine pathology, and to select the surgical access route (hysteroscopic myomectomy) [34].
GCR CLEL 5Grade of Recommendation C (Level of Evidence – 5).
2.5 Other Procedures
It is recommended to perform differential diagnosis of uterine fibroids with adenomyosis, uterine sarcoma, pregnancy, etc., in patients with noted growth of myoma nodes and AUB [33], [40], [41].
Level CLevel 5Level of recommendation evidence C (reliability level of evidence – 5).
It is recommended to perform pathomorphological examination of the surgical material of the uterus – the removed macrospecimen to verify the diagnosis [42], [43], [44], [37].
GCR CLEL 4Grade of Recommendation C (Level of Evidence – 4).
3. Treatment, including drug and non-drug therapies, diet therapy, and pain management
3.1 Conservative Treatment
It is recommended to perform active surveillance for asymptomatic small-sized uterine fibroids (absence of AUB, pain syndrome, growth of myoma nodes, uterine size up to 12 weeks, absence of submucosal myoma nodes) [3], [40], [41].
GCR CLOE 5Grade of Recommendation C (Level of Evidence – 5).
Comments: In the case of an asymptomatic course of the disease with small uterine sizes, medical and/or surgical treatment is not indicated.
It is recommended to administer medical therapy in patients with uterine fibroids to relieve symptoms (AUB, pain syndrome) and concomitant gynecological diseases [40], [41].
GCR CLOE 5Grade of Recommendation C (Level of Evidence – 5).
Comments: When choosing a medical therapy option, one should evaluate not only its efficacy, but also its safety and tolerability, as well as take into account the economic cost-effectiveness of the treatment. Ongoing medical therapy must be evaluated every 3 months, and in case of its ineffectiveness, other drugs should be prescribed. It should be borne in mind that the sole purpose of medical treatment is the relief or elimination of symptoms associated with uterine fibroids, and regression of myoma nodes [45].
It is recommended to use tranexamic acid** in patients with uterine fibroids and AUB to reduce the volume of menstrual blood loss [46], [47], [48], [49].
GGR BLOE 1Grade of Recommendation B (Level of Evidence – 1).
Comments: The optimal daily dose of tranexamic acid** is 3.0 g (up to 4 g/day in severe HMB) for 4 days. Tranexamic acid** helps reduce menstrual blood loss by 40-50%.
The use in children under 18 years of age of tranexamic acid** at a dose of 1 g 3 times a day or 15-25 mg/kg (maximum single dose 1 g) 2-3 times a day for 4 days (intravenously in acute HMB) reduces blood loss volume by 25-50% [49], [50], [51].
It is recommended to use nonsteroidal anti-inflammatory drugs (ATX - Nonsteroidal anti-inflammatory and antirheumatic products) (NSAIDs) in patients with uterine fibroids presenting with dysmenorrhea and HMB to reduce pain syndrome and menstrual blood loss volume [52].
Level CLevel 5Level of recommendation evidence C (reliability level of evidence – 5).
Comments: NSAIDs reduce the activity of COX-2 (the expression of which is significantly higher in uterine fibroids compared to normal myometrium) and prostaglandin levels, which helps reduce the severity of pain syndrome and blood loss volume [3], [53].
It is recommended to use progestogens (according to the Anatomical Therapeutic Chemical (ATC) classification - progestogens) in patients with uterine fibroids for the treatment of HMB [54], [55], [38], [56], [57].
Level CLevel 5Level of recommendation evidence C (reliability level of evidence – 5).
Comments: Progestogens have no effect on stabilizing or reducing the growth of fibroid nodes, however, they can be used as medications to reduce menstrual blood loss volume and for the prevention of endometrial hyperplastic processes [55], [58]. The efficacy of oral progestogens depends on the administration regimen: with a 10-day cyclic regimen (from the 14th to the 25th day of the cycle), efficacy is 0-20%; with a 21-day regimen (from the 5th to the 25th day of the cycle), it is 30-50%.
Progestogen therapy is inappropriate in the presence of submucosal uterine fibroids [19].
It is recommended to use levonorgestrel-releasing intrauterine system (LNG-IUS) 52 mg as an alternative treatment in adult patients of reproductive and perimenopausal age with uterine fibroids and HMB to reduce blood loss volume [55], [59].
GPP ALOE 1Grade of Recommendation A (Level of Evidence – 1).
Comments: The use of LNG-IUS is contraindicated in cases of submucosal localization of fibroid nodes and fibroid nodes with centripetal growth. The LNG-IUS reduces blood loss volume by 74-97% without affecting the size of the fibroid nodes.
It is recommended to use combined hormonal contraceptives (according to ATC – progestogens and estrogens, fixed combinations) in patients with uterine fibroids for contraception and management of HMB [60].
Level of Evidence BLevel of Confidence 2Level of recommendation B (level of evidence – 2).
Comments: This group of medications reduces menstrual blood loss volume [3], [40], [41] without affecting the growth of fibroid nodes [60], [61].
It is recommended to use gonadotropin-releasing hormone (GnRH) agonists (according to ATC – Gonadotropin-releasing hormone analogues) in patients with uterine fibroids and anemia as preoperative treatment, as well as to reduce the size of fibroid nodes and blood loss, including intraoperative blood loss [59], [62].
GGR BLOC 1Grade of Recommendation B (Level of Evidence – 1).
Comments: Gonadotropin-releasing hormone analogues are among the effective medications affecting symptoms caused by uterine fibroids [63]. At the same time, the duration of treatment is limited to 6 months due to side effects (vasomotor symptoms, loss of bone mineral density) without add-back therapy, and subsequently with add-back therapy (low-dose estrogen-progestogen therapy) [18]. The duration of preoperative treatment is limited to 3 months.
It is recommended to use #mifepristone (according to ATC - Antiprogestogens) in adult patients with uterine fibroids and HMB [64], [65], [67].
Level of Evidence BLevel of Confidence 2Level of recommendation B (level of evidence – 2).
Comments: The use of #mifepristone at a dose of 50 mg for 3 months leads to a 25-50% reduction in fibroid size and uterine volume, as well as menstrual blood loss volume down to reversible drug-induced amenorrhea [66], [67], [68], [69]. Mifepristone is contraindicated in patients with submucosal uterine fibroids.
3.2 Surgical treatment
It is recommended to perform surgical treatment for uterine fibroids in patients when indications are present [19], [22], [61].
Level CLevel 5Level of recommendation evidence C (reliability level of evidence – 5).
Comments: Indications for surgical intervention are: 1) HMB leading to anemia; 2) chronic pelvic pain impairing quality of life; 3) compression symptoms of adjacent organs (rectum, urinary bladder, ureters); 4) large tumor size (greater than 12 weeks of pregnancy); 5) rapid tumor growth (increase in uterus size by more than 4 weeks of pregnancy within 1 year); 6) postmenopausal tumor growth; 7) submucosal location of the fibroid node; 8) interligamentous and low (cervical and isthmic) location of fibroid nodes; 9) reproductive dysfunction (pregnancy loss, infertility in the absence of other causes); 10) signs of impaired blood circulation in uterine fibroid nodes (necrosis, edema, hyalinosis). Written informed consent of the patient for the planned scope of surgical treatment is required.
It is recommended to perform total hysterectomy (extirpation of the uterus) in patients with uterine fibroids when surgical indications are present, in the absence of reproductive plans, and after obtaining the patient's informed consent [19], [22], [40], [61].
Level CLevel 5Level of recommendation evidence C (reliability level of evidence – 5).
Comments: The only effective method of treating uterine fibroids is total hysterectomy. Subtotal hysterectomy (subtotal abdominal hysterectomy) may be performed after ruling out cervical pathology [3], [61]. In combination with adenomyosis, given the absence of a clear margin of the lesion, subtotal hysterectomy is undesirable due to the potential for disease recurrence.
It is recommended to perform organ-preserving surgical treatment – myomectomy (enucleation of fibroid nodes) in children and adolescents, as well as in women wishing to preserve reproductive function [3], [70], [71], [72].
GOM ALOE 1Grade of Recommendation A (Level of Evidence – 1).
Comments: Surgical treatment is performed on a scheduled basis in phase I of the menstrual cycle (days 5-14). Myomectomy can be performed via laparoscopic, hysteroscopic, laparotomic, or robot-assisted approaches [18], [70]. In reconstructive and plastic surgeries, the approach is determined based on the clinical situation, availability of a specialized team of surgical physicians, and conditions (availability of equipment).
When performing laparoscopic myomectomy (enucleation of fibroid nodes), the use of morcellation is recommended inside a special containment bag to prevent dissemination [73].
Level CLevel 5Level of recommendation evidence C (reliability level of evidence – 5).
It is recommended to perform electrosurgical hysteroscopic myomectomy – the removal of submucosal fibroid nodes not exceeding 4-5 cm in diameter in patients with uterine fibroids [22], [74], [75].
GPP BLOE 3Grade of Recommendation B (Level of Evidence – 3).
Comments: Electrosurgical hysteroscopic myomectomy can be combined with endometrial ablation and resection. In the case of nascent submucosal nodes, myomectomy should be performed via the vaginal approach with exploration of the uterine cavity. The vaginal approach is most suitable for fibroids located partially or entirely in the vaginal part of the cervix.
Vaginal total hysterectomy (extirpation of the uterus) is recommended in adult patients for the surgical treatment of uterine fibroids (if conditions permit) and uterine size up to 12 weeks [76].
Level of Evidence BLevel of Confidence 2Level of recommendation B (level of evidence – 2).
Comments: Using the vaginal approach requires a number of conditions: sufficient vaginal capacity and uterine mobility; it is often performed in combination with reconstructive and plastic surgeries for prolapse, as well as for stress urinary incontinence.
It is recommended to perform endovascular embolization of uterine vessels (uterine artery embolization - UAE) in patients with high surgical risk as an alternative to surgical treatment in the absence of contraindications in patients not planning pregnancy [61], [77], [78], [79].
Level CLevel 5Level of recommendation evidence C (reliability level of evidence – 5).
Comments: Indications, conditions, and contraindications are determined by the obstetrician-gynecologist.
Uterine artery occlusion via embolization (UAE) may be offered to selected women with symptomatic fibroids who wish to preserve the uterus. Women choosing uterine artery occlusion for fibroid treatment must be counseled regarding potential risks, including the likelihood that the procedure may affect fertility and pregnancy outcomes [21]. Following uterine artery embolization, a lower pregnancy rate, a higher miscarriage rate, and more adverse pregnancy outcomes are recorded compared to myomectomy [22]. UAE is associated with a decrease in ovarian reserve, especially in older reproductive-age patients [61], [79].
It is recommended to perform magnetic resonance-guided focused ultrasound ablation (MRgFUS) (ablation of uterine neoplasms using focused ultrasound under magnetic resonance imaging guidance) or ultrasound-guided ablation in women with uterine fibroids as an organ-preserving treatment method if conditions permit and contraindications are absent [61], [80], [81].
GCR CLOE 5Grade of Recommendation C (Level of Evidence – 5).
Comments: Indications, conditions, and contraindications are determined by an obstetrician-gynecologist.
4. Medical Rehabilitation and Sanatorium-Resort Treatment
There is no specific rehabilitation. Following surgical interventions, it is recommended to have an examination (consultation) by a physical therapy physician to determine a rehabilitation program [82], [83].
GCR CLOE 5Grade of Recommendation C (Level of Evidence – 5).
5. Prevention and Dispensary Observation
Specific prevention for uterine fibroids has not been developed.
6. Organization of Medical Care
Indications for emergency hospitalization in a medical organization:
1) spontaneous expulsion ("birth") of a submucosal myoma node;
2) degenerative changes in the tumor due to impaired blood circulation, accompanied by signs of infection and the onset of "acute abdomen" symptoms;
3) AUB.
Indications for scheduled hospitalization in a medical organization:
1) Surgical treatment of uterine fibroids (see Section 3.2.);
2) Hysteroscopy in case of suspected submucosal location of the nodes.
7. Additional Information
7.1 Uterine fibroids and infertility
It is recommended that patients with uterine fibroids presenting with infertility undergo a comprehensive evaluation including the assessment of the type, characteristics, size, and location of the myoma nodes, as well as parameters characterizing reproductive function status (tubal factor, endocrine disorders, male infertility factor, etc.) to select the management strategy [19], [84], [85].
Level CLevel 5Level of recommendation evidence C (reliability level of evidence – 5).
It is not recommended to administer medical therapy as an independent treatment method for uterine fibroids in the population of women with infertility [86].
Level CLevel 5Level of recommendation evidence C (reliability level of evidence – 5).
It is recommended to perform a preoperative assessment of submucosal uterine fibroids, including determining the size and location of the fibroid, its relation to the uterine cavity, assessing the degree of invasion into the uterine cavity and the thickness of the myometrium to the serosa, in order to determine the surgical approach and extent of surgery [86].
Level CLevel 5Level of recommendation evidence C (reliability level of evidence – 5).
Comments: The combination of hysteroscopy and transvaginal ultrasound examination of the uterus and appendages or hysterosalpingography are the methods of choice [86].
It is recommended to treat submucosal fibroids surgically (hysteroscopically), which increases the pregnancy rate [86].
Level CLevel 5Level of recommendation evidence C (reliability level of evidence – 5).
Comments: In cases of large fibroid size or type 2 nodes, a two-stage hysteroscopic myomectomy may be performed [86].
Patients with submucosal uterine fibroids have a reduced implantation rate in a natural cycle, an increased rate of spontaneous abortion, and a higher incidence of placental insufficiency and pregnancy complications associated with abnormal placental location or premature placental abruption. Myomectomy for a submucosal node increases the likelihood of spontaneous pregnancy.
It is not recommended to remove subserosal fibroids in cases of infertility in the absence of specific indications for surgical treatment (torsion of the node pedicle, impaired blood circulation in the node, symptoms of compression of adjacent organs, large node size, noted node growth) [86].
Level CLevel 5Level of recommendation evidence C (reliability level of evidence – 5).
Comments: The benefits of myomectomy must be weighed against the risks, and the treatment of intramural fibroids must be individualized [86].
It is recommended to individually select the surgical approach (laparoscopic or laparotomic) for myomectomy in women with infertility, based on the number, size, and location of the nodes, the surgeon's qualifications, and the settings for surgical treatment [86].
Level CLevel 5Level of recommendation evidence C (reliability level of evidence – 5).
Comments: The advantage of the laparoscopic approach, along with minimally invasiveness, is the ability to inspect the abdominal cavity organs, including the detection of concomitant gynecological diseases—such as coexisting endometriosis, adhesions, etc., which expands diagnostic possibilities to identify the causes of infertility and perform intraoperative correction (the incidence of concurrent gynecological diseases ranges from 30 to 60% of cases).
It is not recommended to perform uterine fibroid embolization (UFE, endovascular occlusion procedures) as a treatment option for uterine fibroids in women planning pregnancy [86].
Level CLevel 5Level of recommendation evidence C (reliability level of evidence – 5).
7.2 Uterine fibroids and pregnancy
All pregnant patients with uterine fibroids are recommended to undergo a comprehensive fetal ultrasound and pelvic ultrasound (transvaginal and transabdominal) to assess the condition of the fetus and pelvic organs, and to determine management tactics [87].
Level CLevel 3Level of recommendation evidence C (reliability level of evidence – 3).
Comments: Indications, surgical approach, and scope of surgical intervention are determined by a medical board (by decision of a concilium of physicians). Surgical treatment of uterine fibroids during pregnancy is performed only for emergency indications. Indications for surgery during pregnancy include: myoma node necrosis, torsion of the myoma node pedicle, and development of peritoneal signs. Vaginal delivery is the preferred method of delivery. When delivering via Cesarean section, it is advisable to perform a myomectomy (enucleation of the myoma node) if a myoma node impedes fetal extraction [25], [88], [87].
7.3 Uterine fibroids in perimenopause and postmenopause
Asymptomatic small uterine fibroids require dynamic monitoring, taking into account potential oncological risks [89], [90].
For a single small submucosal uterine fibroid in peri- and postmenopause, hysteroscopic myomectomy is performed.
When indications for surgery are present, choosing a radical scope of surgery is preferred. Myomectomy in the perimenopausal period is advisable only if the woman's reproductive function has not been fulfilled and the patient categorically refuses hysterectomy [89], [88] (see 3.1. Conservative treatment).
7.4 Uterine fibroids and malignant uterine diseases
Uterine leiomyosarcoma is a rare mesenchymal tumor characterized by cytologic atypia, a high mitotic index, and tumor necrosis upon pathologic examination of the surgical specimen of the uterus. One in 400 women (0.25%) undergoing surgery for uterine fibroids is at risk for leiomyosarcoma [45]. This is an extremely aggressive malignant neoplasm associated with a poor prognosis. The disease is most commonly diagnosed in the perimenopausal period.
It is recommended to perform a differential diagnosis between uterine fibroids and uterine leiomyosarcoma using comprehensive pelvic ultrasound (transvaginal and transabdominal) and/or pelvic MRI in patients with uterine masses in the presence of rapid fibroid growth (see also Section 2.4 Diagnostic Imaging Studies) [91], [92], [37], [38].
GPP CLOE 4Grade of Recommendation C (Level of Evidence – 4).
Comments: The problem lies in the fact that leiomyomas and leiomyosarcomas cannot be reliably distinguished clinically or by any imaging modality prior to surgery [45].
Additionally, other malignant tumors of the uterus, such as cervical cancer and endometrial cancer, may be the cause of AUB in a patient and require differential diagnosis [22].
Criteria for Evaluating the Quality of Medical Care
№ | Quality criteria | Performance evaluation | |
|---|---|---|---|
1. | Comprehensive pelvic ultrasound was performed (transvaginal and transabdominal) | Yes/No | |
2. | Medical therapy was prescribed to patients with uterine fibroids for symptom relief (AUB, pain syndrome) | Yes/No | |
3. | Pathological examination of the surgical specimen of the uterus (removed macroscopic specimen) was performed | Yes/No | |
4. | Medical therapy was prescribed to patients with uterine fibroids for symptom relief (AUB, pain syndrome) | Yes/No | |
5. | Surgical treatment of uterine fibroids was performed in patients with indications | Yes/No | |
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Appendix A1. Working Group Composition
Leyla V. Adamyan – Academician of the Russian Academy of Sciences, Doctor of Medical Sciences, Professor, Deputy Director of the V.I. Kulakovo National Medical Research Center for Obstetrics, Gynecology and Perinatology of the Russian Ministry of Health, Honored Scientist of Russia, Head of the Department of Obstetrics, Gynecology and Reproductive Medicine at the Russian University of Medicine, Chief Freelance Gynecologist of the Russian Ministry of Health, member of the Society for Reproductive Medicine and Surgery, the Russian Association of Gynecological Endoscopists, the Russian Endometriosis Association, and the Russian Society of Obstetricians and Gynecologists.
Elena N. Andreeva – Doctor of Medical Sciences, Professor, Deputy Director – Director of the Institute of Reproductive Medicine, Head of the Department of Endocrine Gynecology, Professor at the Department of Endocrinology of the National Medical Research Center for Endocrinology of the Russian Ministry of Health, Professor at the Department of Obstetrics, Gynecology and Reproductive Medicine of the Russian University of Medicine, President of the International Association of Obstetricians, Gynecologists and Endocrinologists, member of the Russian Association of Gynecological Endoscopists, the Russian Endometriosis Association, the Russian Society of Obstetricians and Gynecologists, and ROSGEM.
Yulia S. Absatarova – Candidate of Medical Sciences, Senior Researcher at the Department of Endocrine Gynecology, National Medical Research Center for Endocrinology of the Russian Ministry of Health, member of the International Association of Obstetricians-Gynecologists and Endocrinologists.
Natalya V. Artymuk – Doctor of Medical Sciences, Professor, Head of the Department of Obstetrics and Gynecology named after Professor G.A. Ushakova at Kemerovo State Medical University of the Russian Ministry of Health, Chief Freelance Specialist in Obstetrics and Gynecology of the Russian Ministry of Health in the Siberian Federal District, member of the Russian Society of Obstetricians and Gynecologists.
Tatyana E. Belokrinitskaya – Doctor of Medical Sciences, Professor, Head of the Department of Obstetrics and Gynecology, Faculty of Continuing Professional Education, Chita State Medical Academy of the Russian Ministry of Health, Honored Doctor of the Russian Federation, Chief Freelance Specialist in Obstetrics and Gynecology of the Russian Ministry of Health in the Far Eastern Federal District (Chita), member of the Russian Society of Obstetricians and Gynecologists, President of the Trans-Baikal Society of Obstetricians and Gynecologists.
Vitaly F. Bezhenar – Doctor of Medical Sciences, Professor, Head of the Department of Obstetrics, Gynecology and Neonatology at Pavlov First Saint Petersburg State Medical University of the Russian Ministry of Health, Chief Freelance Specialist in Obstetrics and Gynecology for the Healthcare Committee of Saint Petersburg, member of the Society for Reproductive Medicine and Surgery, the Russian Association of Gynecological Endoscopists, and the Russian Society of Obstetricians and Gynecologists.
Aleksandr I. Gus – Doctor of Medical Sciences, Professor, Head of the Department of Functional Diagnostics at the 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.
Yulia E. Dobrohotova – Doctor of Medical Sciences, Professor, Head of the Department of Obstetrics and Gynecology at the Faculty of Medicine, Pirogov Russian National Research Medical University of the Russian Ministry of Health, Honored Doctor of the RF, Honored Worker of Science of the RF, recipient of the RF Government Prize, member of the Society for Reproductive Medicine and Surgery, the Russian Association of Gynecological Endoscopists, and the Russian Society of Obstetricians and Gynecologists.
Natalia V. Dolgushina – Doctor of Medical Sciences, Professor, Deputy Director for Research at the National Medical Research Center for Obstetrics, Gynecology and Perinatology named after Academician V.I. Kulakov of the Russian Ministry of Health, Chief Freelance Specialist in Women's Reproductive Health of the Russian Ministry of Health, member of the Presidium of the Board of the Russian Society of Obstetricians and Gynecologists.
Elena I. Ermakova - Candidate of Medical Sciences, Senior Researcher at the Department of Gynecological Endocrinology, V.I. Kulakov National Medical Research Center for Obstetrics, Gynecology and Perinatology of the Russian Ministry of Health, Vice President of the Russian Society of Gynecological Endocrinology and Menopause Specialists.
Oleg V. Zairatyants – Doctor of Medical Sciences, Professor, Head of the Department of Pathological Anatomy, A.I. Evdokimov Moscow State University of Medicine and Dentistry of the Russian Ministry of Health, Chief Expert Specialist in Pathological Anatomy for Roszdravnadzor in the Central Federal District of Russia, Chairman of the Moscow Society of Pathologists and Vice President of the Russian Society of Pathologists, member of the European Society of Pathology and the International Academy of Pathology.
Andrey V. Kozachenko – Doctor of Medical Sciences, Leading Researcher at the Gynecological Department of the Division of Operative Gynecology and General Surgery, V.I. Kulakov National Medical Research Center for Obstetrics, Gynecology and Perinatology of the Russian Ministry of Health, Associate Professor at the Department of Obstetrics, Gynecology and Reproductive Medicine of the Russian University of Medicine, member of the Russian Association of Gynecological Endoscopists.
Stanislav I. Kiselev – Doctor of Medical Sciences, Professor at the Department of Reproductive Medicine and Surgery, A.I. Evdokimov Moscow State University of Medicine and Dentistry of the Russian Ministry of Health, recipient of the Russian Government Prize in Science and Technology, member of the Russian Association of Gynecological Endoscopists and the Russian Society of Obstetricians and Gynecologists.
Anna I. Malyshkina – Doctor of Medical Sciences, Professor, Head of the Department of Obstetrics, Gynecology and Medical Genetics, Ivanovo State Medical Academy of the Russian Ministry of Health, member of the Society for Reproductive Medicine and Surgery, and the Russian Society of Obstetricians and Gynecologists.
Aleksandr A. Popov – Doctor of Medical Sciences, Professor, Head of the Department of Endoscopic Surgery, Moscow Regional Research Institute of Obstetrics and Gynecology, member of the Russian Association of Gynecological Endoscopists and the Russian Society of Obstetricians and Gynecologists.
Antonina A. Smetnik – Candidate of Medical Sciences, Head of the Department of Gynecological Endocrinology, V.I. Kulakov National Medical Research Center for Obstetrics, Gynecology and Perinatology of the Ministry of Health of the Russian Federation, President of the Russian Society of Gynecological Endocrinology and Menopause Specialists.
Nelli S. Soghoyan - V.I. Kulakov National Medical Research Center for Obstetrics, Gynecology and Perinatology of the Russian Ministry of Health (Moscow).
Aleksandr L. Tikhomirov – Doctor of Medical Sciences, Professor at the Department of Obstetrics and Gynecology, Faculty of General Medicine, Russian University of Medicine, member of the Russian Association of Gynecological Endoscopists and the Russian Society of Obstetricians and Gynecologists.
Narine M. Tonoyan – PhD, Obstetrician-Gynecologist at the National Medical Research Center for Obstetrics, Gynecology and Perinatology named after Academician V.I. Kulakov of the Russian Ministry of Health (Moscow).
Oleg S. Filippov – Doctor of Medical Sciences, Professor, Honored Doctor of the Russian Federation, Chief Freelance Obstetrician-Gynecologist of the Federal Medical-Biological Agency (FMBA) of Russia, Deputy Director of the Federal Research and Clinical Center of Children and Adolescents of the FMBA of Russia, Professor at the Department of Obstetrics, Gynecology and Reproductive Medicine, Russian University of Medicine.
Galina E. Chernukha – MD, PhD, Professor, Chief Researcher at the Department of Gynecological Endocrinology, National Medical Research Center for Obstetrics, Gynecology and Perinatology named after Academician V.I. Kulakov of the Russian Ministry of Health; President of the Interregional Public Organization "Association of Gynecologic Endocrinologists".
Maria I. Yarmolinskaya – Professor of the Russian Academy of Sciences, Doctor of Medical Sciences, Professor, Head of the Department of Gynecology and Reproductive Endocrinology, D.O. Ott Research Institute of Obstetrics and Gynecology, Professor at the Department of Obstetrics and Gynecology, North-Western State Medical University named after I.I. Mechnikov of the Russian Ministry of Health, member of the Russian Society of Obstetricians and Gynecologists.
Elena V. Uvarova – Corresponding Member of the Russian Academy of Sciences, Doctor of Medical Sciences, Professor, Honored Scientist of the Russian Federation, Head of the 2nd Gynecological Department, V.I. Kulakov National Medical Research Center for Obstetrics, Gynecology and Perinatology of the Ministry of Health of the Russian Federation, Professor at the Department of Obstetrics, Gynecology and Reproductology, Institute of Professional Education, I.M. Sechenov First Moscow State Medical University (Sechenov University) of the Ministry of Health of the Russian Federation, Chief Freelance Pediatric and Adolescent Gynecologist of the Ministry of Health of the Russian Federation, President of the Association of Pediatric and Adolescent Gynecologists of Russia, member of the Russian Society of Obstetricians and Gynecologists.
Elena P. Khashchenko – PhD, Leading Researcher at 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.
Ekaterina L. Yarotskaya – Doctor of Medical Sciences, Professor at the Department of Obstetrics, Gynecology and Reproductive Medicine of the Russian University of Medicine, V.I. Kulakov National Medical Research Center for Obstetrics, Gynecology and Perinatology of the Russian Ministry of Health, member of the Society for Reproductive Medicine and Surgery, the Russian Association of Gynecological Endoscopists, the Russian Endometriosis Association, and the Russian Society of Obstetricians and Gynecologists.
Conflict of interest:
All members of the working group declare no conflict of interest.
Appendix A2. Methodology for Developing Clinical Guidelines
Target audience for these clinical guidelines:
1. Obstetricians-gynecologists, general practitioners, family physicians;
2. Students, residents, postgraduate students;
3. Educators, researchers.
Table 1. Level 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 | There is only a rationale for the mechanism of action or expert opinion |
Table 2. Level of Evidence (LoE) grading scale for prevention, treatment, and rehabilitation methods (preventive, therapeutic, and rehabilitative interventions)
LoE | Definitions |
|---|---|
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 | There is only a rationale for the mechanism of action of the intervention (preclinical studies) or expert opinion |
Table 3. Grade of Recommendation (GoR) scale 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 evidence of proper quality; all considered efficacy criteria [outcomes] are unimportant, all studies have low methodological quality, and their conclusions regarding outcomes of interest are inconsistent) |
Procedure for updating clinical guidelines.
The mechanism for updating clinical guidelines provides for their systematic revision at least once every three years, as well as upon the emergence of new evidence-based medicine data on 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
These clinical guidelines were developed taking into account the following regulatory legal documents:
Order of the Ministry of Health of the Russian Federation No. 1130n dated October 20, 2020, "On Approval of the Procedure for Providing Medical Care in the Profile of 'Obstetrics and Gynecology (Excluding Assisted Reproductive Technologies)'" (as amended and supplemented).
Order of the Ministry of Health of the Russian Federation No. 803n dated July 31, 2020, "On the procedure for using assisted reproductive technologies, contraindications, and restrictions on their use."
Savelieva G. M. et al. National Guidelines // Obstetrics. – M.: Geotar-Media. – 2015.
Serov V. N., Sukhikh G. T. Clinical Guidelines. Obstetrics and Gynecology //M: GEOTAR-Media.-4th ed.-2014.-1024 p. – 2014. Moscow: Problems of Reproduction.
Appendix B. Physician Action Algorithms
Diagram
Regimen 2
Appendix C. Patient Information
Uterine fibroids (leiomyomas) are among the most common tumors of the female genital organs.
Inflammatory diseases and abortions significantly influence the development of this benign tumor. In a woman who has undergone 10 abortions by the age of 30, the risk of developing uterine fibroids by age 40 increases twofold. It is an established fact that uterine fibroids are significantly more common in nulliparous women.
In 30-40% of cases, the predisposition to develop uterine fibroids is inherited from mother to daughter. There are so-called "familial forms" of uterine fibroids, where all female relatives in a family—grandmothers, mothers, aunts, sisters—have had fibroids.
Uterine fibroids (leiomyomas) may be asymptomatic and cause no complaints in patients. They are most commonly detected during a routine check-up by an obstetrician-gynecologist. In symptomatic cases, the initial signs of fibroids may include lower abdominal or lower back pain, bleeding, menstrual cycle irregularities, and impaired function of neighboring organs, such as frequent urination. To determine the number of nodes, their size, location, etc., special studies are required: a comprehensive pelvic ultrasound and pelvic MRI. Sometimes, with atypical fibroid locations, ultrasound results may be inconclusive.
Asymptomatic uterine fibroids of small sizes are subject to active surveillance.
If symptoms of the disease are present, medical therapy can be administered (for symptom relief).
In patients planning to preserve or fulfill their reproductive function, reconstructive and plastic surgeries may be performed. However, organ-sparing surgeries carry the risk of disease recurrence.
Currently, myomectomy and hysterectomy (removal of the uterus) can be performed via a laparoscopic approach.
Following laparoscopy, only small "dots" of 0.5–1 cm are visible, as only 5 mm punctures are made for the instruments. The hospital stay is reduced to 1–2 days, and immediately after discharge, the patient can resume her usual lifestyle.
The scope of surgical intervention is a matter of medical confidentiality (no one except the patient herself and the obstetrician-gynecologist will know what specific surgery she underwent).
Appendix G. Assessment Scales, Questionnaires, and Other Evaluation Tools
Not required.