CONTIFORM – SUMMARY
The New User Kit comprises three available sizes, Small, Medium & Large, Silicone Removal Strap, as well as a training DVD and Instructions for Use (IFU).Approximately 75-80% of women will find the Medium size works best, if uncomfortable, the Small is chosen, or if the Medium feels loose then the Large is selected.
The Replacement Unit is supplied by individual size and each includes a silicone strap and the IFU. Clinical information can be gleaned from the resources above.
The pessary is a self-inserted, flexible, intra-vaginal device which helps to keep the neck of the bladder closed during stressful moments – coughing, sneezing, laughing and high impact exercising (gym, running, sports activity etc). Contiform is manufactured in Sydney, produced from an FDA approved medical material – Santoprene, (Santoprene is also used by Cochlear in their transplants). We export to the UK (where it is listed under the UK NHS as a prescription device for stress incontinence) and various countries in the EEC.
It is a man-made, non-latex hydrophobic polymer – this means it cannot absorb water/fluids, thus cannot support any microbial growth. The material is slippery when wet, making it easier to insert.
The Contiform is injection-molded and packaged under clean-room conditions and meets the stringent Quality Management System of ISO 13485 and carries the CE certificate.
Without this certification, it would not be approved by the European and Australian Health Authorities. Contiform is approved by the Australian Therapeutic Goods Administration (TGA).
Contiform is inserted in a folded position and inserted into the vagina. If dryness makes this difficult, a VERY small amount of water-based gel can be used on the tip to facilitate entry.
Do not use Vaseline or too much water based gel as it will only allow the pessary to slip out.
When inserted, the final movement is to gently push with the index finger – this allows the device to sit comfortably under the cervix.
Depending on the degree of prolapse that a woman has, Contiform may not be suitable as a device to prevent stress incontinence – Prof. Kate Moore, who published the clinical study of Contiform, suggested that, as a measure, if the woman can retain a tampon, then the Contiform could be used.
We can assure you that women wearing the Contiform do not feel anything obtrusive when the correct size is used. The device is usually taken out at night, washed in a non-scented soap and left to dry. We have approval that the device can be worn for a continuous period of 5 days – this is useful for active women hiking or bushwalking and has been used by women walking around the Milford Sound in NZ.
As you continue to use the Contiform, you will notice a split appearing within the collar that supports the neck of the bladder.
The split inside the collar is normal. The product will continue to function and prevent stress incontinence until the split begins to reach well over the edge of the collar.
We guarantee that the Contiform Pessary will function for 30 days when used daily. If you are only using the Contiform during high impact exercising, sports, running or when you attend the gym, then the Contiform will last longer.
When the device was designed, the clinical evaluation by Prof. Kate Moore at St George Hospital, Sydney, showed that a small proportion of patients reported not being able to void their bladder completely in the first 24 hrs – there was some discussion that the pressure from the collar of the device may be the cause, however after 24-48 hrs, this appeared to resolve itself. The clinical papers can be found above.
To avoid any possible recurrence, we redesigned the molding dies and placed a weakness in the inside of the collar – this is seen as a split after several squeezes of the device. We test the functionality and pressure of the pessary using a specially-designed jig as part of our Quality Control Compliance and Release procedures.
The Contiform can be used with complete safety and confidence for the 30 day period, the split will eventually .weaken the collar pressure and reduce its ability to prevent stress incontinence. This will alert the customer to discard the unit and purchase a fresh replacement.
If the device fails prematurely and within the 30 day period, please wash and retain the pessary and we will replace it without charge.