Frequently Asked Questions
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Dr. Arabin in India.
Pregnant women with a cerclage pessary
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Medical questions to discuss with your physician
How can I find a physician with experience in pessary treatment?
Pessaries can be inserted by your physician if clinically appropriate. For healthcare providers unfamiliar with the Arabin pessary, instructions are included in each package and are also available online. If your physician has limited experience with pessaries, you should be referred to specialized units or obstetricians with expertise in this area. A list of such specialists in various countries can be found on our website.
Healthcare systems differ worldwide—some have dedicated preterm birth prevention clinics, while others rely on general obstetricians who may not have extensive knowledge in every area of pregnancy care. This can result in varying levels of familiarity with treatments like pessaries, as staying updated on all healthcare advancements can be challenging.
If your clinician is not well-versed in pessary use, always request the instructions and the package label, which includes the pessary’s size and charge number. This information can be shared with the attending physician in case of unexpected hospital readmission.
Seek immediate medical attention if you experience contractions, amniotic fluid loss, or bleeding. If your questions are not adequately addressed, you can contact us at [email protected]. We strive to respond within 1-2 working days.
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How can my doctor select the right size?
Your physician should review the instructions or visit our website, where an automatic calculator is available to determine the appropriate pessary size based on your individual characteristics. You can access it at http://jovihealthcare.in/ by selecting “cerclage-pessary” and entering the required details. This recommendation is based on our extensive experience and is accurate for most women. However, it is not an absolute rule, and your physician should conduct a personal examination to ensure the best-fitting pessary for you.
Always keep in mind that if you experience significant discomfort or pain after the pessary is inserted, you should inform your physician immediately. They may consider adjusting the size or exploring other options to ensure your comfort and safety.
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What is the difference between a cervical pessary with or without wholes?
The shape of perforated (ASQ) and unperforated pessaries is the same. Increased vaginal discharge is the most frequently reported side effect of pessary use. To address this, we incorporated holes into the design to facilitate drainage and reduce the pessary’s surface area. These holes do not impact the therapeutic effectiveness of the pessary. Both designs are intended to support the cervix and help prevent preterm birth.
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What is the difference between a pessary which is dark blue or transparent?
Prior to 2014, cerclage pessaries were manually crafted and featured a blue color. We have since refined the design, reducing the amount of colorant to make any potential impurities more visible. This improved design has been approved by the Food and Drug Administration (FDA) for research use. Dark blue cerclage pessaries are either outdated models or imitations, and we cannot ensure that their materials match the quality of the transparent devices, which have been rigorously tested for compressibility, cytotoxicity, sensitivity, and biological safety.
If a physician unfamiliar with the device mistakes the transparent blue color for amniotic membranes during a speculum exam, you can clarify that you are wearing a transparent blue pessary. The transparent ARABIN® pessary is design-licensed and undergoes annual certification based on comprehensive mechanical, biological, and clinical research.
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When is the cervical pessary best inserted?
The optimal timing for pessary insertion during pregnancy depends on several factors:
- Your obstetric history (such as risk factors for preterm birth, including prior conization, previous preterm birth, or a current twin pregnancy)
- Your cervical length
- Any rapid changes in cervical length
Your obstetrician should reassure you that they will carefully evaluate all these factors before recommending a pessary. If multiple risk factors are present, it is generally advisable to start treatment earlier in the pregnancy, especially if there are early signs of a potential preterm birth.
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How do I know that a cervical pessary is placed correctly?
After the pessary is inserted, you should be able to stand and move around comfortably without any pain. If you feel discomfort or pain, it could mean the pessary is not fitted correctly, and your doctor should check and reposition it if necessary. Your gynaecologist should arrange a follow-up to ensure the pessary stays in the right position. They should also give you clear instructions about your pessary, which you can provide to another healthcare professional in case of an unexpected visit.
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Can a pessary be used in spite of a previous miscarriage or a termination of pregnancy?
A previous miscarriage or termination of pregnancy does not prevent you from being eligible for a pessary if it is clinically recommended. For those with a history of recurrent late miscarriages, it is advisable to seek guidance from experienced specialists early in pregnancy to explore the best therapeutic options.
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Can two pessaries be used (cervical & prolapse pessary)?
As far as we are aware, this approach has not been attempted, and we advise against it due to the discomfort of wearing two pessaries and the potential risk of cervical necrosis. For cases of severe genital prolapse without cervical shortening, a club-shaped pessary (like a Gelhorn pessary) offers more effective support for the pelvic organs, enhancing mobility and providing relief from symptoms.
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Can a pessary be used in (twin) pregnancies after IVF?
IVF in itself is not an indication for needing a pessary. However, pregnancies achieved through IVF—whether single or multiple—are associated with an increased risk of preterm birth. For this reason, regular cervical length monitoring through scans is advised. If a shortened cervix is detected, a pessary may be recommended as a preventive measure.
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When the pessary should be removed?
The pessary must be removed immediately if you experience signs of imminent delivery, such as painful contractions. If a cesarean section is planned, ensure the pessary is not forgotten and is removed beforehand. If you are unsure whether the healthcare team has taken it out, always ask for confirmation. If your water breaks, the pessary should be removed promptly to minimize the risk of infection. In rare cases, it may be left in temporarily to facilitate transfer to a hospital with advanced neonatal care facilities, but these exceptional situations will be thoroughly explained to you by your healthcare team.
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Lifestyle and own decision making
Can I insert or remove the pessary myself?
No, Arabin pessaries for preterm birth prevention are distinct from gynaecological pessaries used to treat vaginal prolapse. Gynaecological pessaries are often self-inserted and removed by patients and are typically worn only during periods of physical exertion, often being taken out at night. In contrast, the cervical pessary used during pregnancy has a different role:
- It is positioned as high as possible in the vaginal fornix to support the cervix, meaning it does not stretch or dilate the vagina.
- It is unlikely to significantly interfere with sexual intercourse, as it is placed high near the cervix, though it may occasionally be felt.
- It modifies the utero-cervical angle in patients with a short cervix, where minimizing manipulation and prostaglandin release is crucial.
As a result, the pessary should remain in place unless a medical reason requires its removal or replacement. In some cases, pregnant women requiring a pessary may also have mild uterine prolapse, causing the pessary to sit lower and be more noticeable during examinations. This is not a cause for concern, as the pessary will still remain securely positioned around the cervix.
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Can I do anything about discharge?
Your healthcare provider should inform you about the possibility of increased or watery vaginal discharge while using a pessary. This is a common side effect and not a reason to remove the pessary. The discharge may accumulate while lying down and appear more noticeable when you stand up, as gravity allows it to drain. Many women find that it is most pronounced in the morning after the discharge has collected overnight. The discharge can sometimes be mistaken for your waters breaking or a vaginal infection. If you are unsure, consult your local healthcare provider for clarification.
It’s important to note that not all women will experience this discharge. Daily hygiene practices should remain the same as in a pregnancy without a pessary. There is no need for special soaps, specific underwear, or treatments like lactobacillus (“good bacteria”). If the discharge is heavy, you may choose to wear a sanitary towel or panty liner to keep sensitive skin dry and comfortable.
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When can a patient with a pessary stay at home or should be hospitalized?
Women with cervical shortening alone, without contractions or additional complications, typically do not require hospitalization, especially if they have a supportive home environment. In fact, treatment with a pessary can often allow patients to remain at home rather than being admitted to the hospital. However, if there is early cervical shortening or additional risk factors such as severe funneling or membrane separation, your physician will determine whether hospital admission is necessary.
In cases where there is no measurable internal cervical length but sufficient external cervical tissue to hold a pessary, indomethacin may be used for 24–48 hours prior to pessary insertion. During this time, patients are advised to stay in the Trendelenburg position. This helps reduce amniotic fluid volume, decreases pressure on the internal os, and may lower prostaglandin release before the pessary is inserted.
Hospitalization allows for closer monitoring of the cervical structure. If no additional symptoms arise, the cervix remains stable, and gestational age progresses, the patient can often be discharged later. However, seek immediate medical attention if you experience vaginal bleeding, abnormal discharge, suspect your waters have broken, feel pain from the pessary, or believe you may be going into labor.
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Can I move (walk) with a pessary?
“Yes, the pessary provides support to the cervix during physical activities. Many patients report that it offers relief, particularly during activities that involve physical strain, such as walking or standing.”
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Can I swim with a cervical pessary?
Yes, you can swim as long as your cervix remains closed. However, always consult your doctor to confirm whether swimming is safe for you. Exercise during pregnancy is widely encouraged, and swimming is often considered an excellent activity for pregnant women. However, if your cervix has started to dilate, there is a risk of bacteria entering the cervix, making swimming inadvisable in such cases.
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Can I have intercourse with a cervical pessary?
Sexuality is a vital aspect of health and well-being. While there is no evidence that intercourse directly causes preterm birth, there is a concern that cervical stimulation could release prostaglandins, potentially triggering labor. Depending on your individual risk factors, your doctor may recommend avoiding sexual intercourse during pregnancy if your risk of preterm labor is significantly high.
When a pessary is placed around the cervix, it should not interfere with sexual satisfaction. However, in cases of genital prolapse, the cervix may sit lower, and the pessary might be felt during intercourse. Always discuss any concerns with your healthcare provider to ensure your care is tailored to your specific needs.
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The pessary looks big. Is it painful to insert a pessary?
Vaginal health is a sensitive topic, as many factors can disrupt the natural balance of vaginal flora. Women who use gynaecological pessaries later in life are often advised to use specialized creams to support vaginal health. During pregnancy, however, the vaginal mucosa is naturally strengthened by high estrogen levels, making such creams rarely necessary—though they are not contraindicated and can be used if vulvar or vaginal irritation arises.
To facilitate the insertion of a pessary, the physician may apply a lubricant. Most women do not require pain relief during the procedure. However, if you experience significant discomfort, your physician may first examine you to rule out potential causes, such as thrush, and discuss suitable pain relief options with you.
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When to ask for an extra control during treatment?
If you experience increasing discomfort, bleeding, abnormal discharge or you think your waters may have broken you should be seen by a doctor. If there are no suspicious findings, you can be re-assured, otherwise there might be an indication to reposition, to remove or change the size of the pessary. Your doctor will arrange any further routine follow up and arrange the pessary to be taken out at an appropriate time.
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Does the pessary lose its function over time?
The silicone used in the pessary maintains its strength and compressibility throughout the entire treatment period during pregnancy. When stored under standard conditions—temperatures between 0°C and 40°C, and without exposure to radiation—the devices have a certified shelf life of up to 10 years.
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Health care providers of pregnant women with cerclage pessaries
Preferably practical questions
Do doctors need training before treating patients with pessaries?
National healthcare boards should prioritize establishing preterm birth clinics staffed by experienced specialists, given the complexity of preterm birth prevention. Although early signs of cervical ripening may be subtle, they can pose significant risks to the child, including potential neurodevelopmental, metabolic, or cardiovascular issues later in life. Proficiency in transvaginal sonography is essential to accurately assess (endo)cervical length, the utero-cervical angle, and funneling. For patients with a history of anatomical malformations, cervical lesions, or conization, a speculum examination should be conducted before recommending a cervical pessary.
Common side effects, such as increased vaginal discharge, should be clearly communicated to patients. Training in pessary insertion and management is crucial, as the clinical course may require adjustments or additional treatments. Gaining expertise in handling unexpected situations takes time, as cases vary widely due to factors such as:
– Maternal size, anatomy, parity, and cultural considerations
– Pre-existing cervical shortening, thickness, or opening of the internal/external cervical os
– Sensitivity to vaginal procedures (e.g., vaginismus, pain, or discomfort)
– Specific obstetric conditions (e.g., uterus bicornis, placenta previa, etc.)
– Degree of genital prolapse or concurrent urinary incontinence
– Sudden preterm contractions or bleeding during treatment
– Type and amount of discharge, requiring differentiation between PPROM and urinary incontinence
– Cervical edema before removal due to contractions or pressure
Studies have shown that the success rates of pessary treatment improve with the experience of physicians and departments, following a learning curve. This underscores the importance of foundational training, as outlined in the European Guideline on Prematurity. The use of medical devices, including pessaries, is governed by the Medical Device Regulation (MDR), which mandates that manufacturers provide detailed instructions and regularly update website materials based on post-market surveillance. Physicians are required to follow these guidelines or document their reasoning if they deviate from them.
What are the key points before cervical insertion?
Indication, Evidence, Function, and Side Effects:
Begin by explaining to the patient the purpose, evidence, function, and potential side effects (such as increased vaginal discharge) of the pessary. Place the patient in a semi-recumbent position and perform a transvaginal sonography to assess cervical length, using centile curves (e.g., Salomon et al.) for guidance. For high-risk patients, consider indicating a pessary earlier (cut-off at the 10th–25th centile) compared to screening patients (cut-off at the 5th–10th centile).
Choosing the Size:
Select the pessary size based on clinical findings and the following guidelines:
a) Outer lower diameter: 65 mm for nulliparous or smaller women; 70 mm for multiparous or taller women.
b) Height of the curvature: 17 mm (rarely used in the first trimester); 21 mm for singleton pregnancies and smaller women; 25 mm for multiple pregnancies and taller women; 30 mm (rarely used in women with genital prolapse).
c) Inner upper diameter: 32 mm; rarely 35 mm for a wide cervix or U-shaped funneling to minimize prostaglandin secretion.
These are general recommendations and can be adjusted for individual patients. Sizes may also be changed if discomfort or displacement occurs. For additional guidance, use the automatic calculator available on the website: http://jovihealthcare.in/. A detailed table is also provided in the paper by Arabin and Alfirevic (2013), accessible on the website.
Documentation and Instructions:
Attach the label from the pessary package to the patient’s chart, as it indicates the size and charge number. Provide the patient with written instructions, including the size and charge number, in case she consults other gynaecologists.
Insertion Technique:
Fold the pessary with the smaller diameter facing upward, directing it toward the posterior fornix. Keep the pessary longitudinally folded during insertion until it reaches the upper vaginal fornix. Gently push it as high as possible into the posterior vaginal vault, ensuring the smaller diameter encircles the cervix. The anterior rim can be gently adjusted toward the sacrum. After insertion, ask the patient to stand and confirm she feels comfortable.
Additional Considerations:
– Perform a vaginal swab only if there is a high risk of preterm birth (PTB) to inform neonatologists.
– Avoid inserting a pessary in cases of contraindications, such as signs of chorioamnionitis, active contractions, Grade III genital prolapse, or absence of cervical tissue (e.g., after a trachelectomy).
– Advise the patient to share the provided instructions with any other healthcare providers she may visit.
– Schedule a follow-up appointment after one week to assess cervical status and pessary placement.
What are the key points during the course of pregnancy?
In asymptomatic patients, it is generally sufficient to assess whether the (rotated) cervix is positioned within the upper ring of the pessary. For high-risk patients (e.g., those with a history of preterm birth [PTB], a short cervix at insertion, or clinical symptoms), an additional transvaginal ultrasound (TVS), ideally focusing on the upper cervical region, is recommended. This helps determine whether hospital admission and/or the administration of indomethacin or corticosteroids may be warranted. However, as a pragmatic approach, we do not recommend corticosteroid administration if the cervical length remains greater than 15 mm.
Bed rest has not been shown to prevent PTB; in fact, women who engage in moderate physical activity tend to have lower rates of PTB. Therefore, we advise patients with a pessary to maintain normal movement while avoiding physical stress (e.g., prolonged standing). Wearing a pessary may provide reassurance and allow for comfortable mobility.
In cases of increased vaginal discharge, it is crucial to differentiate between normal discharge and preterm premature rupture of membranes (PPROM) to avoid risks such as ascending infection, neonatal infection, or unnecessary pessary removal. Differential diagnosis should include an ultrasound to assess amniotic fluid volume and biochemical testing.
If a patient with a pessary is admitted with preterm contractions, PPROM and chorioamnionitis must be ruled out. A TVS should be performed to evaluate cervical structure. If contractions persist and cannot be halted, a speculum and/or clinical examination should be conducted, and the pessary should be removed to prevent cervical injury or excessive pressure on cervical vessels and tissues.
When and how is a pessary best removed?
A cervical pessary is typically removed when the risk of preterm birth (PTB) has passed, usually around 37 weeks of gestation. If a Cesarean section is planned, it may be best to remove the pessary after the patient has received an epidural but before the skin incision—provided there are no contractions or signs of preterm premature rupture of membranes (PPROM).
In cases of confirmed PPROM, the pessary should be removed immediately. However, there may be exceptions, such as:
– When maternal transport is imminent.
– When fetal viability is uncertain, and removal could trigger further contractions.
In such cases, the patient must be admitted and closely monitored by high-risk specialists. Leaving a pessary in place should be a rare exception, requiring informed consent from the patient and proper documentation in medical records.
Pessary Removal Procedure
A demonstration of pessary removal is available in a YouTube video by Prof. Alfirevic. The general steps include:
1. Inserting a finger between the cervix and the upper ring to gently push the cervix back through the inner ring.
2. If cervical edema is present, informing the patient that removal may be uncomfortable or painful.
3. Compressing or squeezing the pessary, as done during insertion, and carefully withdrawing it.
4. If the pessary is stuck due to contractions, edema, or genital prolapse, cutting it with scissors (such as those used for episiotomies) rather than attempting forceful removal.
Once removed, the pessary must not be reused, as it is certified for single use only.
How to deal with excessive secretion after insertion of a pessary?
Cervical Discharge and Pessary Use
Cervical discharge is the most common side effect of pessary treatment, both in urogynaecology and during pregnancy. The amount of discharge varies based on the patient’s microbiome, the material, and the surface of the pessary.
It is crucial to inform patients in advance about this side effect and to reassure them if they are hospitalized that the discharge is not a sign of preterm premature rupture of membranes (PPROM).
Discharge caused by a pessary does not indicate chorioamnionitis or infection, so antibiotic treatment is not necessary. Ongoing studies are exploring whether different pessary materials or the use of probiotics could help reduce discharge.
Do we have to perform a speculum examination before/during pessary use?
Speculum Examination and Pessary Insertion
A speculum examination is not required for all patients with cervical shortening below a certain centile before pessary placement. However, it is recommended in specific cases.
Indications for a Speculum Examination Before Pessary Insertion:
- History of conization or trachelectomy
- History of cervical lesions
- Suspected uterus duplex (presence of two cervices)
- Unclear findings on transvaginal ultrasound (TVS)
- Patient discomfort or suspected pessary dislocation
- Vaginal bleeding
- Difficulty interpreting TVS
- Suspected PPROM (to differentiate between discharge and membrane rupture)
These are relative indications, and if TVS can provide clear answers, the decision to perform a speculum examination rests with the physician in charge.
Is a vaginal swabs/pH detection before/during treatment indicated?
Vaginal and Cervical Swabs in Pessary-Treated Patients
The indication for a vaginal or cervical swab in patients with a cervical pessary is no different from other pregnant patients at increased risk of preterm birth (PTB). Physicians should inform patients that vaginal discharge alone does not necessarily indicate a change in the vaginal microbiome and should not be treated with antibiotics, as antibiotic use can disrupt the microbiome more significantly.
In some countries, neonatologists may request information on the vaginal microbiome, particularly regarding streptococcus, which should be treated if delivery is imminent. However, this applies to all patients at risk of spontaneous preterm birth (SPTB), not just those with a pessary.
Vaginal pH measurement is performed in a few countries to assess the risk of bacterial vaginosis or dysbiosis, but its sensitivity and specificity in predicting PTB remain unclear. This has led to unnecessary antibiotic use without proven benefits. Current best practices do not recommend vaginal pH measurement before or during pessary treatment.
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How often do we perform digital/sonographic examinations?
Pessary Follow-Up and Examination Guidelines
At the first follow-up visit, a cautious digital examination should be performed to ensure that:
- The upper ring properly surrounds the cervix.
- The pessary is not dislocated and remains rotated towards the sacrum.
If dislocation occurs, the pessary can be repositioned by:
1. Pushing the posterior part upward as high as possible.
2. Applying slight pressure on the anterior part to rotate it into the correct position.
MRI studies have demonstrated that a pessary can alter the utero-cervical angle and cervical length.
Additional Assessments for High-Risk Patients
For patients with additional symptoms or at increased risk of preterm birth (PTB), a transvaginal ultrasound (TVS) may be useful to:
- Reassure the patient.
- Determine the need for corticosteroids.
- Assess the necessity of hospital admission.
If silent progressive cervical shortening or funneling occurs before 30 weeks of gestation, the first-line pharmacological treatment should be indomethacin suppositories (100–200 mg/day).
Minimizing Prostaglandin Secretion
- Digital examinations can induce prostaglandin secretion. Therefore, during follow-up, it may be sufficient to gently check if the anterior rim remains in position.
- TVS manipulation behind the cervix can also trigger prostaglandin release. This can be minimized by carefully guiding the TVS transducer over the anterior lip of the cervix until the cervical length is visualized.
When to Perform a Speculum Examination
A speculum examination is indicated in cases of:
- Cervical discharge with suspected PPROM.
- Unexplained vaginal bleeding.
- Suspected pessary dislocation.
In such cases, a speculum examination helps determine whether early removal is necessary or can be avoided.
Summary
A brief digital examination or anterior TVS should be preferred, as they involve minimal cervical manipulation while ensuring proper pessary placement and cervical monitoring.
What to do if a patient declines pessary treatment?
Patient Communication and Pessary Tolerance
Every specialist should take the time to explain clinical and sonographic findings thoroughly, discussing available treatment options and the latest research. The way information is communicated significantly influences whether a patient accepts or declines pessary treatment.
Pessary Fit and Challenges
In rare cases, large multiparous patients may find that the pessary is too small to stay in place, leading to dislocation. In such instances, options include:
- A custom-made larger pessary (produced through specialized modeling).
- Using the largest available size.
- Patients with vaginismus may experience difficulty with pessary insertion and removal due to muscular tension.
Managing Discomfort
Approximately 1 in 100 patients may find a pessary uncomfortable. In such cases, potential solutions include:
- Trying a smaller size, which may improve tolerance.
- Considering pessary removal, if discomfort persists.
Ensuring clear communication and individualized care can help optimize patient comfort and treatment adherence.
Can a physician disinfect a pessary after use?
Disinfection and Reuse of Pessaries
In previous evaluations, we investigated whether disinfectants could prevent bacterial colonization on pessaries. However, since disinfection protocols vary across countries and not all solutions can be assessed for their effectiveness and impact on material integrity, our notified body advised against recommending disinfection before insertion.
Pessary Safety and Hygiene
- Disinfection is no longer recommended prior to pessary insertion.
- All pessaries undergo tempering after production and are regularly tested for bioburden to ensure hygiene and safety.
- Pessaries must not be reused on another patient under any circumstances.
Demonstration and Cleaning
- If physicians wish to show a pessary to a patient, physical washing is usually sufficient for cleaning.
- While the pessary material can withstand sterilization, it is classified as a single-use device to eliminate contamination risks.
- For demonstration purposes, we provide distributors with “proof pessaries” specifically intended for patient education.
Preferably Theoretical Questions
Which studies are the best?
All clinical procedures must be conducted under the supervision of experienced clinicians. Even patient communication requires a level of expertise. While statisticians may attempt to suggest that everything can be predicted, this is not the case. We operate in a world filled with uncertainty, where rapid decisions often need to be made based not only on theoretical knowledge but also on practical experience. Globally, there are varying guidelines regarding the prevention of spontaneous preterm birth (sPTB). The World Health Organization (WHO) emphasizes that screening for a disease is only advisable if it can lead to improved outcomes. Unfortunately, following the initial publication of a randomized controlled trial (RCT) by Goya et al. in 2012, which included singleton and twin pregnancies, and the subsequent sub-analysis by Liem et al. in 2013, several studies were conducted by inexperienced personnel, potentially influencing the negative results observed. Many retrospective meta-analyses have incorporated low-quality trials, often without adhering to the study pyramid. Consequently, the results of these meta-analyses can be inconsistent, especially when different selection criteria for included RCTs are applied. Underpowered and unregistered RCTs should not be included in any meta-analysis. It would be prudent to await the findings of ongoing prospective meta-analyses. It is unrealistic to expect that pessaries can prevent preterm birth (PTB) in all patients. Some evidence suggests that pessaries may be less effective in patients with a history of preterm premature rupture of membranes (PPROM). Further research is necessary to understand the mechanism of pessaries in the cervico-vaginal space, particularly in the context of tissue sensitivity to dysbiosis. Studies have primarily shown benefits in twin pregnancies. Long-term follow-up data over three years in children treated with pessaries indicate a number needed to treat (NNT) of 1 in 6 to prevent severe disability or death. Overall, pessary treatment should align with the Triple Aim framework: enhancing patient satisfaction, improving population health outcomes, and reducing costs.
Can a pessary be combined with vaginal progesterone?
Both treatments appear to be suitable for a similar group of patients with singleton pregnancies and cervical shortening. Currently, there are various options for managing cervical shortening, including initiating one treatment or even combining both. In twin pregnancies, however, there is no evidence that vaginal progesterone reduces the risk of spontaneous preterm birth (sPTB) (Dodd et al., 2017). As a result, pessaries may be the preferred option in these cases. This is supported by the first randomized controlled trial (RCT) comparing both treatments in twin pregnancies, which found that a cervical pessary was significantly more effective in reducing poor outcomes and sPTB rates in a predefined subgroup (Dang et al., 2019).
For singleton pregnancies, one RCT demonstrated that the addition of a pessary to vaginal progesterone treatment improved neonatal outcomes by reducing preterm birth (PTB) rates (Saccone et al., 2017). It is recommended to initiate treatment earlier in patients with additional risk factors compared to those identified through routine screening. However, a historical cohort study found that adding vaginal progesterone to pessary treatment did not show significant benefits, aside from a reduced length of stay in the neonatal intensive care unit (NICU) (Stricker et al., 2016).
Further high-quality studies are needed to directly compare these treatments and determine the most effective options for specific patient groups.
Can a pessary be combined with a cervical cerclage?
The first patient to receive a pessary, based on transvaginal ultrasound (TVS) findings, was a woman with a history of losing two children due to preterm birth. During her third pregnancy—a twin gestation—she underwent a cerclage procedure but developed funneling up to the stitch at 17 weeks. As an emergency measure, a pessary was placed in addition to the cerclage, successfully prolonging the pregnancy to 37 weeks. While this was an individualized intervention, observational case series since then have suggested that combining a pessary with a cerclage may lead to better outcomes. However, there are currently no randomized controlled trials (RCTs) to confirm this. Ongoing RCTs are now evaluating the effectiveness of these treatments, both individually and in combination, for singleton and twin pregnancies.
Can pessaries be placed in women after i.m. progesterone?
Intramuscular progesterone has traditionally been used in Anglo-American countries for patients with a history of preterm birth but without cervical shortening. However, its use is uncommon in Central Europe. Recent findings from the PROLONG study suggest that intramuscular progesterone may not offer significant benefits. In Germany, 17-alpha hydroxyprogesterone caproate (Proluton®) is no longer available. While there are no systematic studies demonstrating that patients already on 17-alpha hydroxyprogesterone caproate would benefit from adding a pessary, patients can be reassured that the combination is safe, as individual cases have been successfully managed with both treatments.
What to do if the cervix is ≤ 10mm or membranes are visible?
Treatment decisions should be tailored to the patient’s specific clinical symptoms, the extent of cervical dilation, and gestational age. Upon admission, it is critical to exclude signs of chorioamnionitis and uterine contractions. A transvaginal ultrasound should be performed to evaluate cervical length, the degree of funneling, and the presence of sludge. For singleton pregnancies before 24 weeks, cervical cerclage may be considered as an option. However, we typically recommend placing or retaining a pessary to avoid potential complications linked to undetected chorioamnionitis. The patient may be positioned in Trendelenburg, and indomethacin (suppositories) can be administered before 32 weeks to reduce prostaglandin production. The pessary size should be chosen based on the funneling shape: a 32 mm upper diameter for V-shaped funneling and 35 mm for U-shaped funneling. Additional measures, such as corticosteroids or tocolytics, may be indicated depending on the clinical context. A vaginal swab should be taken to assess the risk of preterm birth, inform neonatal care, or initiate antibiotics if streptococcus or resistant pathogens are identified. Preliminary, unpublished observational data in patients with funneling suggest that the use of a pessary alone is not associated with an increased risk of neonatal infections.
What do you do whilst waiting for the swab result?
In patients with intact membranes, we advise performing a vaginal swab only when preterm birth is imminent, primarily to inform neonatologists and rule out streptococcus infection. Importantly, pessaries can be placed immediately without waiting for swab results. Antibiotic use can disrupt the vaginal microbiome, potentially leading to an imbalance in beneficial or harmful lactobacillus strains. Animal studies have shown that certain bacteria can directly alter cervical tissue structure. In the study by Goya et al. (2012), the type of vaginal colonization remained unchanged during pessary use. However, some studies have reported widespread antibiotic use, which may have inadvertently increased the risk of preterm birth or cerebral palsy. Chronic infections of the decidua or membranes—often associated with a history of curettage or assisted reproductive technology (ART)—do not necessarily correlate with changes in the vaginal microbiome.
How often do you add progesterone to a pessary?
In twin pregnancies, vaginal progesterone has not been shown to reduce the risk of spontaneous preterm birth (sPTB), as highlighted in the meta-analysis by Dodd et al. The meta-analysis by Romero, which suggested a positive effect for vaginal progesterone, relied heavily on a single trial from Egypt that was neither placebo-controlled nor pre-registered. According to Prior et al. (2017), such trials should not be included in meta-analyses. A direct comparison between pessary and vaginal progesterone in twin pregnancies demonstrated advantages for the pessary (Dong et al., 2019).
In singleton pregnancies, pessary treatment was our preferred option for patients with cervical shortening until 2011. Following the publication of Hassan et al., we conducted a historical cohort study in singleton pregnancies, adding vaginal progesterone for both screening and high-risk patients. However, no significant differences were observed, except for a shorter stay in the neonatal intensive care unit (NICU), which may have been influenced by the study’s historical design (Stricker et al., 2016). A direct comparison between vaginal progesterone and pessary in singleton pregnancies found no significant differences in preventing preterm birth (Cruz-Melguizo et al., 2018). Further studies are needed to clarify the effectiveness of these interventions individually or in combination.
What if a cervix with a pessary is progressively shortening?
We advise against removing a pessary to place a cerclage in patients with progressive cervical shortening due to the potential risks of amnioinfection and sepsis. Instead, we recommend supplementing treatment with indomethacin suppositories (at least 200 mg/day before 32 weeks), admitting the patient for close observation, positioning them in Trendelenburg, and carefully monitoring for signs of chorioamnionitis. It is challenging to predict which patients will benefit from efforts to prolong pregnancy. In patients with a history of preterm premature rupture of membranes (PPROM), multiple curettages, or assisted reproductive technology (ART), chronic inflammation is more likely to be present, which may reduce the effectiveness of the pessary.
Can a pessary be used in a triplet pregnancy?
Overdistension, a phenomenon well-documented in twin pregnancies, is even more pronounced in triplet pregnancies. This leads to earlier cervical shortening and, consequently, higher rates of preterm birth (PTB) in triplets compared to twins. To date, there are no large-scale trials specifically focused on triplet pregnancies. However, in an unpublished historical cohort study conducted in the Netherlands, we found that early transvaginal sonography combined with early pessary treatment resulted in a significant prolongation of pregnancy in triplet pregnancies compared to controls who did not receive this intervention.
Can cervical pessaries be used in patients with placenta previa?
Patients with placenta previa are at risk of bleeding due to cervical shortening, which can cause a shift in the layers of the lower uterine segment. Theoretically, stabilizing the cervix with a pessary may help prevent both cervical shortening and vaginal bleeding. A study by Barinov et al. (2016) demonstrated that the combined use of a pessary and vaginal progesterone resulted in a 2.5-fold reduction in rates of vaginal dysbiosis, bleeding, and preterm birth. However, it remains unclear whether this effect was primarily due to the pessary. Importantly, placenta previa is not a contraindication for pessary use. Further research is needed to determine whether a pessary should be applied early in pregnancy, even in the absence of cervical shortening, or reserved for cases of precocious cervical ripening identified by transvaginal ultrasound (TVS).
Patients and health care providers to treat genital prolapse or stress incontinence
For patients with interest in special aspects of pelvic dysfunction we recommend our introduction video “Junction with Pelvic Dysfunction” with the link: https://youtu.be/7jrqal8Y0bM
For patients with interest in special aspects of pelvic dysfunction using a cube pessary we recommend our introduction video with the link: https://youtu.be/3ypTINfC0Yo
What is the best way to clean my pessary?
In most cases, patients can independently manage their pessaries, including changing and cleaning them as needed. The frequency of these tasks depends on the type of pessary. Cube or tandem pessaries should be removed each evening and reinserted every morning. These pessaries have a thread attached to a fixed button at the center. Cube pessaries should be cleaned nightly under warm running water, with any residue gently removed using a soft toothbrush. If an unpleasant odor develops, a pH-neutral soap solution can be used. For other pessary types, cleaning is simpler—just rinse under warm running water, optionally with a mild soap solution. Since each pessary is used by only one patient, sterilization or boiling is unnecessary. Disinfectants are not required and are not recommended, as they can irritate the mucous membranes and disrupt the natural vaginal flora.
Can I wear my pessary during sports activities?
Activities such as horseback riding, running, jumping, or dancing can exacerbate symptoms of prolapse or urine loss. As a result, some women who do not typically require a pessary may choose to wear one specifically during these activities. For patients already using a pessary, the device does not need to be removed for any type of physical activity or sport. During swimming, pessaries can remain in place, as neither chlorine nor salt water affects the silicone material. When using a non-perforated cube pessary, a small amount of fluid may collect behind the device, but this can be easily dried off when the pessary is removed in the evening. This poses no risk to the patient.
Is there a risk of allergic reactions to the ingredients of the pessaries?
Allergic reactions to silicone are extremely rare and have not been reported in over 50 years of pessary use. All our pessaries are made from biologically compatible silicone, which undergoes rigorous testing using validated methods before distribution and after a simulated period of 10 years to ensure safety and durability.
What is the shelf life of pessaries?
The durability of our products, confirmed through rigorous aging tests, is 10 years, ensuring their functionality and biocompatibility during storage. From the date of first use, the devices can be safely used for at least 6 months without limitations. If any defects are noticed within the first six months of use, we recommend sending us a photo of the device along with the label showing the lot number. In such cases, the patient will receive a free replacement. To maintain the device’s integrity, avoid unnecessary actions such as loosening the button or boiling the pessary, as these can compromise its quality.
How do I know which size and model is appropriate for my condition?
The variety of pessary types and sizes available is displayed on our website. Generally, we categorize them into two main families:
- Product family Aa: Ring-shaped pessaries designed for prolapse grades 1-2 and/or incontinence.
- Product family Ab: Cube/tandem or club pessaries intended for prolapse grades 3-4 and/or incontinence.
When selecting the appropriate size, many physicians rely on their experience. For those new to fitting pessaries, we offer fitting sets that can be cleaned, sterilized, and reused. For ring-shaped pessaries, the healthcare provider determines the size by identifying the best-fitting green adaptation ring. For cube pessaries, a conversion table is provided in the instructions to guide the selection process.
Which pessary can be used during pregnancy to treat prolapse and/or incontinence?
The Cerclage pessary is designed to prevent preterm birth during pregnancy and can also alleviate symptoms of mild genital prolapse. If the cervix is of normal length, we recommend the following:
- A urethra bowl pessary for managing stress incontinence during pregnancy.
- A sieve bowl pessary for treating prolapse grade 1-2.
- A club pessary for addressing genital prolapse grade 3-4.
Customized pessaries are also available and can be requested based on individual needs. However, cube pessaries should not be used during pregnancy.
What is the reason for increased discharge?
All pessaries act as a ‘foreign body’ within the vagina, which is why the most common side effect of pessary therapy is increased vaginal discharge.
Every individual has a unique microbiome in open body cavities, such as the mouth, bowel, or vagina. Pessary therapy does not alter the natural composition of these microorganisms. Increased discharge is rarely a sign of infection but is most often caused by mild irritation.
We recommend maintaining standard hygiene practices. For postmenopausal women, special attention should be given to vaginal mucosa care. This may include using estrogen cream twice a week, applying a fatty cream (such as Vaseline® or Linola®) daily, and optionally using a pH stabilizer (like Vagisan®). These creams can be applied during pessary insertion. If the discharge contains blood or has a strong, unpleasant odor, it is important to consult a physician.
How do I use the pessary correctly?
Each pessary is accompanied by clear instructions for insertion and removal. For the cube pessary, it is essential to position the thread-button combination toward the vaginal introitus to ensure the thread remains accessible. When removing the pessary, avoid pulling the thread directly. Instead, gently move the pessary back and forth to release the vacuum effect. Once the vacuum is released, the thread can be used to aid removal, which is easier if one leg is elevated, such as by resting it on a chair. If the thread cannot be reached, the pessary can be manually removed, or a physician should be consulted for assistance.
What additional treatments are indicated for urogynaecological pessary therapy?
During pregnancy, the use of additional creams is not necessary. However, in the pre- and postmenopausal periods, pessaries should be coated with estrogen creams to help strengthen the vaginal mucosa (e.g., applied twice a week before insertion). Daily use of a lubricating cream (such as Vaseline® or Linola®) and a pH-stabilizing cream (e.g., Vagisan®) can help maintain vaginal health, support tissue elasticity, and enhance sexual well-being.
Can pessaries cause pain and micturition problems?
Any pessary should enhance quality of life, not diminish it. If a pessary causes pain, difficulties with urination or defecation, it may indicate that the type or size of the pessary needs adjustment. In such cases, consult your gynaecologist. If you are unsure or need further assistance, feel free to contact us at [email protected].
Should a pessary be removed during the menstruation?
Annular pessaries allow for the natural drainage of discharge and blood, making removal unnecessary during bleeding. After the bleeding stops, it is advisable to replace the pessary, clean it thoroughly, and gently remove any fibrin deposits using a soft toothbrush. Unperforated cube pessaries should be avoided during the initial days of bleeding. For perforated cube pessaries, regular cleaning every evening—or more frequently if required—is recommended to ensure proper hygiene and functionality.
Is it possible to have sexual intercourse with the pessary inserted?
Generally, pessaries are used during the daytime to manage symptoms of genital prolapse and/or incontinence, as symptoms are rarely noticeable when the patient is lying down. Annular pessaries, when positioned relatively high in the vagina, do not interfere with sexual intercourse and do not need to be removed in the evening. Cube and tandem pessaries, however, are typically removed each evening, which can be done before intercourse if needed. Applying estrogen cream, Vaseline®, or Vagisan® in the morning can enhance long-term sexual comfort. On the other hand, club pessaries, which are used for severe prolapse, may be disruptive due to their protruding stalk.
Can I use any pessary with mechanical contraceptives?
When using intrauterine devices (such as Mirena® or Jaydess®/IUD), care should be taken to avoid dislodging the fine thread. For cube pessaries, which are usually worn during the day and removed in the evening, it is important to carefully release the vacuum effect before removal. Hormone-containing vaginal rings can safely remain in place above any pessary. However, there is no evidence or data regarding the combined use of a pessary with a diaphragm, and we do not recommend this combination due to the risk of the diaphragm becoming dislodged or improperly positioned.
Can I use the pessary before and after surgery on the genital tract?
In many countries, it is recommended to trial pessary therapy before considering pelvic floor surgery. International studies have shown no significant differences in patient satisfaction or effectiveness between pelvic floor surgery and the use of vaginal pessaries. Another benefit of pre-operative pessary treatment is the option to apply estrogen creams to the pessary, which can enhance local blood supply and improve surgical outcomes. Additionally, experienced specialists often recommend pessaries after pelvic floor surgery to stabilize the results and prevent early recurrence. This approach should be discussed with patients prior to surgery.
What is a customized pessary?
A request form for customized (individually made) pessaries can be downloaded from http://jovihealthcare.in/. Under the MDR (Medical Device Regulation), a physician’s prescription is mandatory for the fabrication of a customized device. Patients are advised to verify with their health insurance providers whether the costs for customization are covered. Non-commercially available models can be requested, and designs are often personalized, such as by incorporating metal inlays (similar to Hodge pessaries). Furthermore, new designs are continuously being developed, particularly for use during pregnancy and the postpartum period, to better meet patient needs.
Can the use of pessaries lead to a worsening of genital prolapse or incontinence?
Pessary therapy is designed to improve the quality of life for women of all ages. Historically, pessaries were often left in place for extended periods. However, with ring-shaped pessaries, prolonged use can sometimes cause further dilation of the vaginal walls, potentially requiring the use of larger sizes over time. To prevent this, it is recommended to remove the pessary in the evening and reinsert it in the morning. For pessaries that adhere through a vacuum effect, such as cube pessaries, there is no risk of additional dilation. In fact, these pessaries often result in patients needing smaller sizes over time, as the pelvic tissue is massaged and strengthened by the device’s mechanism.