A pessary is a gynecological device (vaginal ring) that is used in cases of prolapse or prolapse of the uterus and vagina. It is installed to mechanically hold the walls of the vaginal passage and the body of the uterus when the muscle tissue of the pelvic region or diaphragm is significantly weakened. In gynecology, this pathology is called genital prolapse, and it causes a woman a lot of inconvenience both in her personal and everyday life. Previously, prolapse was treated in the only known way - surgical intervention, which did not always give the desired effect, and besides, not every woman could have surgery. With the advent of the pessary, the treatment of genital prolapse has received an excellent alternative, especially in cases where surgical intervention is contraindicated for various reasons, for example, due to the patient’s age or pregnancy.
Indications
The introduction of a gynecological pessary is indicated for the following reasons:
- prolapse and prolapse of the uterine body;
- urinary incontinence;
- presence of contraindications for surgical treatment;
- the threat of spontaneous abortion, which is provoked by isthmic-cervical insufficiency;
- in case of categorical refusal of the patient from the operation;
- for preliminary treatment of gynecological diseases before surgery.
Contraindications to the procedure
Before carrying out the procedure for introducing a gynecological pessary, a woman must undergo some examination in order to exclude the presence of infectious diseases of the genital organs and candidiasis. To do this, she will need to undergo a number of tests and tests, such as a general blood and urine test, a smear for flora, an HIV and RW test, etc.
A genital tract infection can cause a number of complications associated with the presence of a foreign body in the vagina. Therefore, the uterine ring is not installed in the presence of cervical erosions, sexually transmitted infections, precancerous diseases, and uterine bleeding. Also, a narrow vaginal passage and any inflammatory diseases of the pelvic organs are contraindications for the installation of a pessary. Meanwhile, after appropriate treatment of the infection and elimination of the causes that caused uterine bleeding, a vaginal ring can be installed in the woman.
NuvaRing®
If any of the following conditions/diseases or risk factors are present, a thorough assessment of the benefit-risk ratio of using the drug NuvaRing® should be carried out and discussed with the woman before starting to use the drug. In case of exacerbation of diseases, deterioration of the condition or the appearance of the first symptoms of conditions/diseases or risk factors, the woman should immediately consult a doctor to decide whether to discontinue or the possibility of further use of the drug.
Risk of developing VTE and ATE
The use of any combined hormonal contraceptives (CHCs) is associated with an increased risk of developing venous and arterial thrombosis and thromboembolism (such as DVT and PE, myocardial infarction, cerebrovascular disorders). These diseases are rare. The use of drugs containing levonorgestrel, norgestimate or norethisterone as a progestogen component has the lowest risk of developing VTE.
The use of other medications, such as NuvaRing®, can double the risk of developing this complication. An increased risk is present after initial use of CHCs or resumption of use after a break of 4 weeks or more. The choice in favor of a CHC with a higher risk of developing VTE can only be made after consultation with the woman to ensure that she fully understands the risk of VTE associated with the use of NuvaRing®; the effect of the drug on her existing risk factors and that the risk of developing VTE is greatest in the first year of using the drug.
VTE can be life-threatening or lead to death (in 1-2% of cases).
Thrombosis of other blood vessels, for example, hepatic, mesenteric, renal, cerebral veins and arteries or retinal vessels, has occurred extremely rarely with the use of CGCs.
Symptoms of deep vein thrombosis (DVT):
unilateral swelling of the lower limb or along the vein, pain or discomfort only in an upright position or when walking, local increase in temperature, redness or discoloration of the skin in the affected lower limb.
Symptoms of pulmonary embolism (PE)
: difficulty or rapid breathing; sudden cough, including with hemoptysis; sharp pain in the chest, which may intensify with deep inspiration; sense of anxiety; severe dizziness; fast or irregular heartbeat. Some of these symptoms (eg, shortness of breath, cough) are nonspecific and may be misinterpreted as signs of other more common and less severe conditions (eg, respiratory tract infection).
ATE can lead to stroke, vascular occlusion, or myocardial infarction.
Symptoms of a stroke:
sudden weakness or loss of sensation in the face, limbs, especially on one side of the body, sudden confusion, severe or prolonged headache for no apparent reason, unilateral or bilateral loss of vision; problems with speech and understanding; sudden disturbance in gait, dizziness, loss of balance or coordination; sudden loss of consciousness or fainting with or without a seizure.
Other signs of vascular occlusion
: sudden pain, swelling and slight cyanosis of the extremities, “acute” abdomen.
Symptoms of myocardial infarction:
pain, discomfort, pressure, heaviness, a feeling of compression or fullness in the chest or behind the sternum, radiating to the back, jaw, upper limb, epigastric region; cold sweat, nausea, vomiting or dizziness, severe weakness, anxiety or shortness of breath; fast or irregular heartbeat.
ATE can be life-threatening and lead to death.
In women with a combination of several risk factors or high severity of one of them, the possibility of their mutual reinforcement should be considered. In such cases, the degree of increase in risk may be higher than with a simple summation of factors. In this case, the use of NovaRing® is contraindicated.
The risk of developing thrombosis (venous and/or arterial) and thromboembolism or cerebrovascular disorders increases:
- with age;
- in women who smoke (with an increase in the number of cigarettes or an increase in age, the risk increases, especially over the age of 35);
- if there is a family history (for example, venous or arterial thromboembolism in close relatives or parents under the age of 50 years). In the case of a hereditary or acquired predisposition, the woman should be examined by an appropriate specialist to decide on the possibility of using CHC;
— for obesity (UTI more than 30 kg/m2);
- with dislipoproteinemia;
- for arterial hypertension;
- for migraine;
- for diseases of the heart valves;
- with atrial fibrillation;
- in case of prolonged immobilization, major surgery, any operation on the lower extremities or major trauma. In these cases, the use of CHCs should be discontinued (in the case of planned surgery, at least four weeks before it) and not resumed for two weeks after the end of immobilization. Temporary immobilization (eg, air travel lasting more than 4 hours) may also be a risk factor for the development of VTE, especially in the presence of other risk factors.
The possible role of varicose veins and superficial thrombophlebitis in the development of VTE remains controversial.
The increased risk of thromboembolism in the postpartum period should be taken into account.
Peripheral circulatory disorders may also occur in diabetes mellitus, systemic lupus erythematosus, hemolytic uremic syndrome, chronic inflammatory bowel disease (Crohn's disease or ulcerative colitis) and sickle cell anemia.
An increase in the frequency or severity of migraine (which may also precede cerebrovascular events) during the use of CHCs is grounds for immediate discontinuation of these drugs.
Biochemical indicators indicating a hereditary or acquired predisposition to the development of venous or arterial thrombosis include: resistance to activated protein C, hyperhomocysteinemia, antithrombin III deficiency, protein C deficiency, protein S deficiency, antiphospholipid antibodies (anticardiolipin antibodies, lupus anticoagulant).
The risk of thrombosis and thromboembolism during pregnancy and the postpartum period is higher than when taking low-dose CHCs (containing less than 0.05 mg ethinyl estradiol).
If VTE or ATE is suspected or confirmed, use of the drug should be stopped immediately. In this case, it is necessary to use effective contraception, since anticoagulants (coumarins) have a teratogenic effect.
Risk of developing tumors
The most important risk factor for developing cervical cancer is infection with the human papillomavirus (HPV). Epidemiological studies have shown that long-term use of COCs leads to an additional increase in this risk, but it is unclear how much of this is due to other factors, such as increased frequency of cervical screening and sexual behavior, including the number of sexual partners and less frequent use of barrier contraceptives. and their cause-and-effect relationship. Epidemiological data regarding the incidence of cervical cancer in women using the drug NuvaRing®
There are no data from epidemiological studies regarding the risk of developing cervical cancer in women using the drug NuvaRing®.
A meta-analysis of the results of 54 epidemiological studies found a small increase (1.24) in the relative risk of developing breast cancer in women taking COCs. The risk gradually decreases over 10 years after stopping the drugs. Breast cancer rarely develops in women under 40 years of age, so the additional incidence of breast cancer in women who take or have taken COCs is small compared to the overall risk of developing breast cancer. Women who use COCs are diagnosed with earlier clinical stages of breast cancer than women who have never used COCs. The observed increased risk may be due to earlier diagnosis of breast cancer in women taking COCs, the biological effects of COCs, or a combination of both.
In rare cases, cases of development of benign, and even more rarely, malignant liver tumors have been observed in women taking COCs. In some cases, these tumors led to the development of life-threatening bleeding into the abdominal cavity. The doctor should consider the possibility of a liver tumor in the differential diagnosis of diseases in a woman taking NuvaRing® if symptoms include acute pain in the upper abdomen, liver enlargement, or signs of intra-abdominal bleeding.
Hypersensitivity reactions
Hypersensitivity reactions, such as angioedema and anaphylaxis, have been observed during use of the drug NovaRing®. If you suspect angioedema and/or anaphylaxis, you should stop using the drug NuvaRing® and carry out appropriate treatment.
Hepatitis C
In clinical trials of the drug combination for the treatment of hepatitis C virus ombitasvir/paritaprevir/ritonavir with or without dasabuvir, increases in ALT levels greater than 5 times the upper limit of normal were observed significantly more often in women using drugs containing ethinyl estradiol, such as COOK. The use of NovaRing® should be discontinued before starting therapy with the combination of ombitasvir/paritaprevir/ritonavir with or without dasabuvir (see section “Contraindications” and “Interaction with other drugs”). The use of NuvaRing® can be resumed approximately 2 weeks after completion of treatment with the combination of these drugs.
Other states
- In women with hypertriglyceridemia (or a family history of this condition), the risk of developing pancreatitis may increase while using CHCs.
- Although slight increases in blood pressure (BP) have been described in many women using COCs, clinically significant increases in BP have been reported rarely. However, if a persistent clinically significant increase in blood pressure develops while using the drug NuvaRing®, the use of the drug should be stopped and treatment of arterial hypertension should be started. If normal blood pressure values are achieved with the help of antihypertensive therapy, use of the drug NuvaRing® can be continued.
- The following conditions have been reported to develop or worsen during pregnancy and when taking CHCs, but their relationship with the use of CHCs has not been proven: cholestatic jaundice and/or pruritus associated with cholestasis; formation of gallstones; porphyria; systemic lupus erythematosus; hemolytic-uremic syndrome; chorea; herpes during pregnancy; hearing loss associated with otosclerosis. Cases of Crohn's disease and ulcerative colitis have also been described with the use of CHCs.
— In women with hereditary forms of angioedema, exogenous estrogens may cause or worsen symptoms of angioedema.
— Acute or chronic liver diseases may require discontinuation of the drug NuvaRing® until liver function tests return to normal.
— Recurrence of cholestatic jaundice and/or itching caused by cholestasis, which first developed during pregnancy or previous use of sex hormones, requires discontinuation of the drug NuvaRing®.
- Although estrogens and progestogens can affect insulin resistance and glucose tolerance, in patients with diabetes mellitus using low-dose CHCs, as a rule, no dose adjustment of hypoglycemic drugs is required. However, patients with diabetes mellitus should be carefully monitored while using NuvaRing®.
- Chloasma can sometimes develop, especially in women with a history of chloasma during pregnancy. Women with a tendency to chloasma should avoid prolonged exposure to the sun and ultraviolet irradiation while using NuvaRing®.
— Conditions of a woman in which she will not be able to insert the ring correctly or in which the ring may fall out: cervical prolapse, bladder hernia and/or rectal hernia, severe chronic constipation.
— In very rare cases, women have unintentionally inserted the NuvaRing® vaginal ring into the urethra and possibly into the bladder. When symptoms of cystitis appear, it is necessary to consider the possibility of incorrect insertion of the ring.
— Cases of vaginitis have been described during the use of the drug NuvaRing®. There are no clinical data regarding the effect of vaginitis therapy on the effectiveness of the use of the drug NovaRing®, as well as the effect of the use of the drug NovaRing® on the effectiveness of therapy for vaginitis.
— Very rare cases of a ring sticking to the vaginal mucosa have been described, requiring its removal by a medical professional. In some cases where tissue had grown around the ring, removal was accomplished by cutting the ring without cutting the vaginal tissue.
Medical examination/consultation
Before prescribing the drug NuvaRing® or resuming its use, you should carefully review the woman’s medical history (including family history) and conduct a gynecological examination to exclude pregnancy. It is necessary to measure blood pressure, conduct an examination of the mammary glands, pelvic organs, including a cytological examination of cervical smears and some laboratory tests, to exclude contraindications and reduce the risk of possible side effects of the drug. The frequency and nature of medical examinations depend on the individual characteristics of each patient. but medical examinations are carried out at least once every 6 months. A woman should read the instructions for use and follow all recommendations. The woman should be informed that NuvaRing® does not protect against HIV infection (AIDS) and other sexually transmitted diseases.
Reduced efficiency
The effectiveness of the drug NovaRing® may decrease if the regimen is not followed (see the subsection “Deviations from the recommended regimen” of the section “Dosage and Administration”) or concomitant therapy is carried out that reduces the concentration of etonogestrel in the blood plasma (see section “Interaction with other drugs” ).
Changes in the nature of menstruation
During use of the drug NovaRing®, acyclic bleeding may occur (“spotting” spotting or sudden bleeding). If such bleeding is observed after regular cycles with the correct use of the drug NuvaRing®, you should contact your gynecologist to conduct the necessary diagnostic studies, including to exclude organic pathology or pregnancy. A diagnostic curettage may be required.
Some women do not bleed after the ring is removed. If the drug NuvaRing® was used according to the instructions, it is unlikely that the woman is pregnant. If the recommendations of the instructions are not followed and there is no bleeding after removing the ring, as well as if there is no bleeding for two cycles in a row, pregnancy must be excluded.
Effects of ethinyl estradiol and etonogestrel on a sexual partner
The possible pharmacological effects and extent of exposure of ethinyl estradiol and etonogestrel to male sexual partners (due to absorption through penile tissue) have not been studied.
Ring damage
In rare cases, when using the drug NuvaRing®, ring rupture was observed. The core of the drug NuvaRing® is solid, so its contents remain intact, and the release of hormones does not change significantly. Vaginal injury associated with ring rupture has been reported. If the ring ruptures, it usually falls out of the vagina (see the recommendations in the subsection “What to do if the ring has been temporarily removed from the vagina” in the “Dosage and Administration” section). If the ring ruptures, a new ring must be inserted.
Ring falling out
Sometimes the NuvaRing® vaginal ring may fall out of the vagina, for example, if it is inserted incorrectly, when a tampon is removed, during sexual intercourse, or due to severe or chronic constipation. In this regard, it is advisable for a woman to regularly check the presence of the NuvaRing® vaginal ring in the vagina (for example, before and after sexual intercourse). If the NuvaRing® vaginal ring falls out of the vagina, you must follow the recommendations of the subsection “What to do if the ring has been temporarily removed from the vagina” in the “Method of administration and dosage” section.
Features of choosing a pessary
For the manufacture of supporting vaginal rings, special types of materials are used - silicone and polypropylene, which are characterized by increased resistance to the effects of vaginal microflora. Uterine rings, according to their use and effect on the female body, are usually divided into the following types:
1. Supportive pessaries - they prevent genital prolapse. These include:
- thick uterine rings;
- flat pessaries;
- rings that are attached directly to the uterus:
- cup-shaped vaginal rings - have special holes for removing secretions formed in the vagina;
- medical devices that are used in cases of urinary incontinence.
2. Uterine rings, the purpose of which is to fill the vagina. All cubic and mushroom-shaped pessaries belong to this type.
Recently, quite a few types and types of pessaries have been developed in medicine, but in practice, gynecologists use only two dozen. The attending physician decides which vaginal ring the patient needs. It is based on the collected medical history, the results of the examination, and the woman’s age. But the most important determining factor is the pathology for which the pessary is used. All this data is taken into account by the gynecologist, and he prescribes a device model strictly individually for each patient.
There are models of uterine rings that are inserted for a month or a month and a half, but some models require daily removal and processing. In any case, the initial insertion and removal of the pessary should be carried out on an outpatient basis by a competent specialist.
Nuvaring
Vaginal ring for contraception. Used intravaginally. Contains ethinyl estradiol (estrogen) and etonogestrel (gestagen). The contraceptive effect is achieved by suppressing ovulation. In addition to the main effect, Nuvaring has a positive effect on the menstrual cycle, makes it regular, reduces the intensity of bleeding and pain. It also reduces iron deficiency in the body and reduces the risk of endometrial and ovarian cancer.
Reception scheme
Nuvaring is inserted into the vagina and remains there for three weeks. The insertion and removal of the ring occurs on the same day of the week. After removing the ring, you need to take a week's break, during which withdrawal bleeding occurs - it usually begins after 2-3 days and may not stop by the time a new ring needs to be inserted. The new ring is inserted on the same day of the week on which the first ring was inserted. Thus, the menstrual cycle is exactly four weeks.
To insert the ring into the vagina, a woman should choose a comfortable position. This can be done, for example, standing, raising one leg, squatting, or lying down. Nuvaring should be lightly squeezed with your fingers and inserted into the vagina. There are no rules or regulations for the location of the ring - the main thing is that the woman is comfortable. The contraceptive effect will be present in any case. After insertion, the ring must remain in the vagina continuously for 3 weeks.
It is convenient to remove the ring by picking it up with your index finger, or pressing it between the index and middle fingers. If the ring was accidentally removed ahead of schedule (for example, when removing a tampon), it should be rinsed with warm water and placed in the vagina as quickly as possible.
Side effects when using Nuvaring may be as follows:
- headache, migraine, dizziness;
- depression, emotional instability, irritability, anxiety, feeling tired;
- nausea, abdominal pain, diarrhea, vomiting;
- decreased libido;
- soreness, tension and enlargement of the mammary glands;
- change in body weight;
- vaginal discharge, cervicitis;
- fear of sexual intercourse, discomfort during sexual intercourse;
- urinary tract infections (including cystitis).
Contraindications are:
- thrombosis and thromboembolism;
- migraine with focal neurological symptoms;
- diabetic angiopathy;
- pancreatitis in combination with a high degree of hypertriglyceridemia (LDL concentration more than 500 mg/dL);
- severe liver diseases, liver tumors;
- hormone-dependent malignant tumors (established or suspected);
- vaginal bleeding of unknown etiology.
Nuvaring cannot be used during pregnancy and breastfeeding.
Nuvaring may be recommended for use with extreme caution and close monitoring in the following cases:
- diabetes mellitus;
- obesity;
- high blood pressure;
- atrial fibrillation, heart defects;
- dyslipoproteinemia;
- liver or gallbladder diseases;
- Crohn's disease or ulcerative colitis;
- sickle cell anemia;
- systemic lupus erythematosus;
- hemolytic uremic syndrome;
- epilepsy;
- fibrocystic mastopathy;
- uterine fibroids;
- congenital hyperbilirubinemia (Gilbert, Dubin-Johnson and Rotor syndrome);
- chloasma.
For women over 35 who smoke, Nuvaring is not the drug of choice.
In cases of prolonged immobilization and major surgical interventions, Nuvaring is not recommended.
Start of reception
If hormonal contraceptives were not used in the previous menstrual cycle, Nuvaring is administered from the first to the fifth day of menstruation. Within a week from the date of insertion of the ring, it is recommended to additionally use barrier methods of protection.
If hormonal oral contraceptives were used in the previous period, Nuvaring is administered on the day on which the first tablet from the new package of the drug could have been taken. If you are taking a biphasic drug, Nuvaring is administered the day after the last placebo tablet.
If you used progestin oral contraceptives (mini-pills) in the previous period, then switching to Nuvaring can be done on any day.
If an implant was used in the previous period, then Nuvaring should be administered the next day after removal of the implant.
If an injection method of contraception was used in the previous period, then Nuvaring is administered on the day when the next injection could have been given.
If a progestin intrauterine device was used in the previous period, then Nuvaring should be administered the next day after removal of the IUD.
In all cases of previous progestin contraception (mini-pill, implant, injection, IUD), it is recommended to additionally protect yourself with barrier methods during the first week of using Nuvaring.
After an abortion performed in the first trimester of pregnancy, Nuvaring can be administered immediately. No additional precautions are required.
After childbirth or abortion performed in the second trimester of pregnancy, you should wait three weeks and administer Nuvaring in the fourth week. If use Additional contraception is not required. However, if you did not start using Nuvaring in the fourth week, you can do it later, while simultaneously using barrier methods of contraception during the first week. If there was sexual intercourse during the postpartum period, pregnancy must be excluded before inserting the ring.
What to do if the regimen for using Nuvaring is forced to be violated?
The contraceptive effect guaranteed by the manufacturer can only be ensured if the drug is used according to the regimen. If the regime is not followed, this effect may be reduced. In such situations, you should adhere to the following recommendations:
If there is a forced break in using the ring for less than three hours, the contraceptive effect is not reduced. The ring needs to be inserted as soon as possible. No other measures are required.
If the break was more than three hours, then you need to place a new ring in the vagina as soon as possible. Additionally, you should use a barrier method of contraception for a week. If there was sexual intercourse during the “no ring” period, pregnancy may occur. If the ring was outside the vagina for more than three hours during the third week of its use, then the pattern of using Nuvaring changes. You need to place the ring in the vagina as soon as possible and remove it seven days after the ring is reinserted (that is, to shift the withdrawal bleeding). After seven days, the ring should be removed and follow the usual pattern: a week's break, then insertion of a new ring.
Please note: if the ring is removed from the vagina for a period of more than three hours during the first week of using the ring, pregnancy may occur.
In cases where the regimen of using the ring was not followed and there is no withdrawal bleeding, it is necessary to do a pregnancy test\.
Important points
Women who use Nuvaring are recommended to visit a gynecologist at least once a year.
If you are prescribed drug therapy, be sure to tell your doctor that you are using Nuvaring. In combination with a number of drugs, it can reduce its contraceptive effect. These are primarily phenytoin, phenobarbital, primidone, carbamazepine, rifampicin, oxcarbazepine, topiramate, felbamate, ritonavir, griseofulvin, preparations with St. John's wort extract, penicillins and tetracyclines. While taking these medications, it is advisable to use barrier methods of protection.
