Product features:

Arabin cube pessaries, perforated and unperforated (all with button)

Components and storage:
The cube pessary is made of tissue-friendly silicone with a button and permanently welded thread for easy changing. The pessary can be stored at room temperature (1 to 30 °C), protected from UV radiation and without direct contact with reactive media such as gas, ozone, or mineral oil.

Indication:
The cube pessary, due to its vacuum effect, stays in place better than other pessaries. The unperforated version holds better than the perforated version, which, however, is easier to change. The cube pessary can be used to treat various degrees of vaginal prolapse. When the prolapse is so severe that the vagina is everted, it is called a prolapse. A cube pessary inserted into the vagina can reposition the prolapsed organs back into their original position. The cube pessary stays in place better than other products due to its suction effect. Treatment indications also include urinary retention, discomfort during intercourse, and pre-operative use (with estrogen cream).

Training:
If a treating physician has little experience in pessary therapy, we recommend training (online/hands-on), visiting our website www.dr-arabin.de, or referral to experienced colleagues.

Sizes:
The size of the cube pessary depends on the cube's edge length. Ten different sizes are available, ranging from a minimum edge length of 25 mm (size 0) to a maximum edge length of 75 mm (size 9). Correct size selection by a treating physician is essential for secure fit and comfortable use. The cube should be large enough to stay in place during straining, coughing, and other movements. A cube that is too large can press on the bladder or bowel and make removal difficult. Treatment should always begin with a cube that stays in place during both coughing and straining. After a few days or weeks, it may be necessary to change the pessary size (usually to a smaller model). Larger models are used in cases of vaginal constriction.

Use:
The treating physician will fit the pessary during the initial examination. Cube pessaries are removed by the wearer herself every evening and reinserted in the morning, following initial instructions from a doctor or another healthcare professional. This allows the vaginal walls to recover overnight. In some cases, however, it may be beneficial to use the pessary at night to prepare the tissue before surgery. This should only be done on the advice of the treating physician. In cases of a large prolapse, a smaller pessary can be used at night for patients requiring care, but always in consultation with the treating physician. It is advantageous to apply an ointment over two to three edges of the cube when inserting it. This not only provides lubrication but, when using estrogen, also improves tissue perfusion and promotes the restoration of a normal vaginal flora. The choice of cream or ointment should be discussed with the treating gynecologist. To insert the pessary, place your foot on a chair or the edge of the bed, similar to inserting a tampon. Alternatively, you may need to insert the pessary with your legs spread, perhaps leaning against a wall or lying down. Push the pessary as far into the vagina as possible. Only then will the pessary be correctly positioned and cause no pressure discomfort. To remove it, after breaking the vacuum (by gently rocking it back and forth), pull the pessary down by the string – ideally in different directions, possibly with gentle pressure – until you feel resistance from the pelvic floor muscles. Use your index and/or middle fingers to move the reachable edges of the pessary to release the vacuum. Then, while maintaining gentle tension on the string, remove the pessary. If the patient is unable to urinate, or if the pessary worsens incontinence, it should be removed and a smaller (different) model chosen. The patient should be instructed to report any discomfort – including during urination/bowel movements – immediately during pessary therapy.

Follow-up examination:
After the initial insertion of the pessary, the patient should be examined again after approximately one week (at the latest after four weeks). At each follow-up examination, the pessary should be removed and cleaned with lukewarm water, while the vagina is examined for erosions, pressure necrosis, or allergic reactions. It is not uncommon for the size of the pessary to be adjusted after the initial fitting. The patient should then have another examination after one to two weeks. If tears or other defects are found in the pessary, it must be replaced. Ideally, the patient should be cared for by the same physician for the duration of the treatment. However, in the case of a motivated patient who demonstrates effective pessary management, follow-up examinations may be spaced further apart at the physician's discretion.

Application/Cleaning:
The cube pessary is classified as a therapeutic product and may only be used by a single patient. It should be cleaned under running water without the use of disinfectants. Mucus or material residue can be carefully removed with a soft toothbrush, if necessary, without loosening or tearing the button.

Side effects/complications:
Although pessaries are a safe form of treatment, they are a foreign body. Therefore, the most common side effect is increased discharge and possibly odor. This side effect can be reduced by using additional measures (creams, hygiene). During bowel movements, the pessary may descend further (see image top right). The patient should be instructed to locate the pessary and reposition it in the vagina. Postmenopausal women are more prone to vaginal mucosal injuries. By promoting epithelial maturation, treatment with estrogen cream can make the vaginal mucosa more resistant to erosions. Prolonged use and/or estrogen deficiency can lead to pressure discomfort in the vaginal mucosa. This is most problematic if a pessary is forgotten. In case of intolerance, a different model, such as a cup or club pessary, can be chosen. The doctor will make this decision. If the string breaks, the pessary should be removed as soon as possible. In women with a hidden form of bladder weakness (masked incontinence), a cube pessary can worsen urinary incontinence. In these cases, it should be discussed with the treating physician whether a different model (urethral or urethral cup pessary) is needed or whether a different treatment is required. For patients requiring care or who are anxious, a caregiver or family member can be involved in handling the pessary change; however, a doctor must always be consulted in the event of bleeding or serious infection.

Length of stay:
The therapy is short-term (< 30 days). However, we recommend changing the pessary every evening! It may only be reused by the same patient.

Contraindications:
For patients who require care or are unable to ensure regular pessary changes, a caregiver or family member can assist with the process. However, the treating physician should be consulted in cases of pain, bleeding, or significant vaginal discharge. An allergy to silicone is extremely rare but would be a contraindication. Active infections, including inflammatory diseases of the vagina or pelvis, preclude the use of a pessary until the infection has cleared. Patients who do not understand or ignore advice, or for whom follow-up is not possible, should not be given a pessary.

Warning:
In case of pain, bleeding, or excessive discharge with odor, the treating physician must be consulted as soon as possible. Although creams and gels can improve treatment with pessaries, their compatibility with the pessary material has not been tested. Serious complications attributable to the pessary should be reported to the manufacturer and, if necessary, to the responsible authorities.

Durability:
The pessary has a shelf life of 10 years in its original packaging from the date of production. Once inserted, we recommend using the pessary for three years. If any cracks, deformations, or discoloration are found upon inspection, the pessary must be replaced immediately.

Disposal:
Used and damaged silicone products can be disposed of at home in a sterile condition, packaged in the regular household waste. In medical facilities, country-specific regulations must be followed.

This patient information leaflet was last revised in July 2020.

Source: www.dr-arabin.de
As of January 2022