Perforated cubic pessary with button edge length 45 mm/wplk5/

Asymptomatic or symptomatic pelvic organ prolapse of any degree, stress urinary incontinence, and other manifestations of pelvic floor dysfunction in cases where surgical intervention is temporarily undesirable for the patient or completely impossible;
the need for urodynamic assessment of hidden urinary incontinence in the preoperative period (predicting the outcomes of surgical intervention);
Cubic pessaries should also be used in cases where other types of pessaries are ineffective.

INTRODUCTION AND REMOVAL OF THE PESSARY.
After disinfection, 2-3 edges of the cube are coated with a small amount of cream approved for use in gynecology (as indicated, with estriol). Before inserting the cubic pessary, the prolapsed organs must be returned to their anatomically correct position. The pessary is compressed and inserted into the vagina with the button facing the vaginal vault. At this time, the retrieval string of the pessary should be easily accessible. Due to the elastic properties of the material, the pessary regains its original shape in the vagina.
In some cases, when preparing for surgery and only at the doctor's indication, overnight use of the pessary may be beneficial. In cases of significant prolapse, smaller-sized pessaries may be used at night.
Thanks to the elastic properties of silicone, the discomfort for the patient during insertion/removal is minimal.
For self-insertion of the cubic pessary (similar to the insertion of a hygiene tampon), a woman can place one foot on a chair or the edge of the bed. If this is too difficult, the pessary can be inserted while spreading the legs, leaning against a wall, or in a lying position. The pessary should be pushed as deep as possible into the vagina to ensure correct positioning and avoid discomfort.
To remove the cubic pessary, the patient should pull it by the string in different directions to relieve the vacuum effect until she feels resistance from the pelvic floor muscles. Using the index and middle fingers, pressure can be applied to the edges of the pessary to completely eliminate the vacuum effect, then gently pull the pessary out by the string.
If the patient cannot replace the pessary herself, it is advisable to invite a nurse or a family member to assist with the removal/insertion of the pessary.

RECOMMENDATIONS FOR PATIENTS
Before handling the pessary, it is essential to thoroughly wash hands with tap water and soap or antiseptic.
After inserting the pessary, ensure that there are no unpleasant sensations or difficulties with urination and defecation. If pain occurs in the vagina or if the device falls out, a pessary of a different size should be used.
Try to self-insert and remove the pessary under the supervision of a doctor.
During the use of the pessary, regular gynecological examinations are necessary. This is required to assess the effectiveness and monitor the ongoing treatment.
At home, the pessary can be washed with warm tap water and soap.
To prevent inflammatory complications, it is important to follow the recommendations of the treating physician, hygiene rules, and the duration of continuous pessary wear.

Pessary - hypoallergenic flexible silicone
Thread material - nylon
Button - plastic

Local infectious process; pessary installation is possible after vaginal sanitation and obtaining results of repeated bacteriological examination;

WARNINGS
Before use, carefully read the Instructions for Use of the medical device.
Use the device only as intended.
The cubic pessary is designed for prolonged (up to 12 hours) contact with the mucous membranes of the patient's vagina. The pessary is inserted during periods of physical activity, i.e., inserted in the morning and removed at night.
Do not use after the expiration date indicated on the packaging.
Do not use if there are any damages (cracks, cuts, etc.).
Consider contraindications for the use of cream with estriol (e.g., pregnancy, breastfeeding, estrogen-dependent tumors).

DISINFECTION AND CLEANING
The device is non-sterile; it must be removed from the packaging and treated with an antiseptic before use.
The procedure should be performed either with disposable sterile gloves or without gloves, but only after thorough antiseptic treatment (soap, antiseptic solution).
It should only be reused (insertion/removal as part of the prescribed therapy) after processing. At home, the pessary can be washed with warm tap water and soap; chlorine-containing agents may be used.

REQUIREMENTS FOR MAINTENANCE AND REPAIR OF THE MEDICAL DEVICE
The device is not subject to maintenance and repair.

DISPOSAL OF THE DEVICE
There are no special requirements for their disposal and destruction. In accordance with local regulations and guidelines, the user may dispose of these medical devices along with regular household waste.

STORAGE AND SHELF LIFE
Store at a temperature of +15 to +25°C, protecting from direct sunlight.
The shelf life of the device is 10 years.

In rare cases, with pronounced cystocele, the placement of a pessary may provoke the onset of stress urinary incontinence (hidden urinary incontinence); this symptom should be taken into account when planning the type and extent of surgical intervention.

CUBICAL PESSARY WITH BUTTON PERFORATED EDGE LENGTH 45MM /WPLK5/ - a medical device in the shape of a cube with concave surfaces, which achieves a vacuum effect and reliable support for prolapsed pelvic organs.
The model of the cubical pessary with a button (perforated) has openings for the drainage of vaginal secretions.
The thread, securely fixed by the button, is used to facilitate the removal of the cubical pessary from the vagina.
Cubical pessaries are made of flexible biocompatible silicone, which does not harm tissues, allowing them to be easily and painlessly inserted and removed by both the doctor and the patient independently.

MECHANISM OF ACTION
The cubical pessary is inserted into the vagina, providing additional support and returning the prolapsed pelvic organs to their original anatomical-physiological position. This eliminates/reduces the manifestations of prolapse and descent of internal genital organs and associated symptoms (e.g., stress urinary incontinence).

CHOOSING THE SIZE OF THE PESSARY
The size of the pessary is selected by the obstetrician-gynecologist individually for each patient.
The initial selection of the pessary size is performed in the lithotomy position of the patient (on the gynecological chair) with a full bladder.
The size of the cubical pessary depends on the length of the edge of the cube.
There are 10 different sizes, from size 0 (edge length of the cube 25 mm) to size 9 (edge length of the cube 75 mm).

Cubical pessary with button (perforated) type WPLK
Article Size (edge length), mm
WPLK 0 25
WPLK 1 29
WPLK 2 32
WPLK 3 37
WPLK 4 41
WPLK 5 45
WPLK 6 55
WPLK 7 65
WPLK 8 70
WPLK 9 75

The selection of the cubical pessary can be done in several ways.
1. Using an adaptation ring, it is possible to select cubical pessaries sizes 0-5.
Table of corresponding sizes of the cubical pessary based on testing with the adaptation ring pessary
Pessary
Adaptation ring, diameter Cubical Pessary/edge length of the cube
45-50 mm sizes from 0/up to 25 mm
55-60 mm sizes from 1/up to 29 mm
60-70 mm sizes from 2/up to 32 mm
70-75 mm sizes from 3/up to 37 mm
80-85 mm sizes 4/up to 41 mm

90 mm sizes 5/up to 45 mm

• Using the gh size according to the POP-Q classification (pelvic organ prolapse quantification system). The gh size is external, from the outlet of the urethra to the posterior edge of the hymen.
This size will approximately equal the edge of the cubical pessary. Thus, it is possible to select sizes 0-9 of cubical pessaries. This method of size selection (by gh size) is possible for previously unoperated patients.

The correct selection of the size of the cubical pessary ensures its safe fixation, adequate support, and absence of problems during independent use.
The cube must be large enough to provide the necessary support and remain in place during movement.
However, a pessary that is too large may compress the bladder or intestines and be more difficult to remove.

Treatment should begin with a smaller cube that is retained during coughing, straining, and movement, and does not cause discomfort.
After several days or weeks of wearing, a size adjustment of the pessary may be required, either larger or smaller.
In cases of isolated uterine prolapse, a small-sized cubical pessary is placed in the upper third of the vagina; in cases with additional prolapse of the bladder and intestines, a larger pessary is placed in the middle third of the vagina.
The patient should learn to independently remove and insert the pessary in the presence of a doctor.

Cubic pessary with button, perforated, edge length 45 mm/wplk5/ - a medical device used in women for the treatment and prevention of diseases caused by pelvic floor dysfunction. The perforation of the product ensures the drainage of vaginal secretions, which reduces the risk of developing inflammatory diseases. The cubic pessary Dr.Arabin is made of hypoallergenic flexible silicone, making its use as comfortable as possible for the patient and does not affect her quality of life. The selection of the appropriate size of the pessary and the initial procedure for the installation and removal of the pessary are performed strictly by a qualified obstetrician-gynecologist. After selecting the appropriate pessary, the doctor instructs the patient on how to independently insert and remove the device. Please read the instructions before use.