Introducing ProVate The New Era
in Pelvic Organ Prolapse
Self-Management

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Pelvic Organ Prolapse (POP)

Empowering Women

Are you suffering from Pelvic Organ Prolapse (POP)?

You’re not alone… Around 50% of the female population above the age 30, worldwide, are affected by some degree of POP . Symptoms of POP include, among others, feeling of a lump within or outside the vagina, discharge, bleeding, constant pelvic heaviness, back-pains, difficulties in evacuating the bladder or the bowel, difficulties in walking, and others. If you any of these symptoms, you should be examined by your OBGYN.

What causes POP?
Can I prevent having POP?

There are many causes for POP, mainly related to vaginal birth. However, other factors, such as constipation, chronic cough, obesity, aging and decline in hormones level, also contribute to the formation of POP.

Avoidance of some of the causes, such as constipation, chronic cough and obesity may reduce the incidence of POP. 

What are the treatment options for POP?

Treatment of POP is divided into either surgical or non-surgical management.

Surgery is indicated in more severe cases of POP, or in cases where women are not able or not willing to use pessaries or are wishing to try and have a one-time procedure. Surgery may have various complications, and there is a certain amount of failure involved, which may require more surgical procedures.

Most women need only the non-surgical options which may include

  • Pelvic Floor Physiotherapy (PFP) which is associated with relief of some POP symptoms but does elevate the prolapsed organs
  • Use of pessaries -vaginal inserts made of silicone or plastics are inserted into the vagina and lift the prolapsed organs. Pessaries are reusable only, and in most cases, insertion and removal are done by an HCP at the office, usually every 3 months, hence there is a dependency upon office appointments. Insertion and removal may be associated with discomfort or pain, and usage if frequently associated with discharge, spotting, foul-smell, infections, and hampered intercourse. This is why management dropout rate is high, usually within the initial 2 years.
  • Pelvic Floor Physiotherapy (PFP) which is associated with relief of some POP symptoms but does elevate the prolapsed organs
  • Use of pessaries -vaginal inserts made of silicone or plastics are inserted into the vagina and lift the prolapsed organs. Pessaries are reusable only, and in most cases, insertion and removal are done by an HCP at the office, usually every 3 months, hence there is a dependency upon office appointments. Insertion and removal may be associated with discomfort or pain, and usage if frequently associated with discharge, spotting, foul-smell, infections, and hampered intercourse. This is why management dropout rate is high, usually within the initial 2 years.

 

The ProVate device

ring pessary

make it your decision

ProVate – the new disposable self-management option for POP

OUR BENEFITS

What is the ProVate device

ProVate is a new medical device intended for home-use self-management of pelvic organ prolapse in women. ProVate was invented and developed by the same company (ConTIPI Medical) who developed the Impressa device for stress urinary incontinence, which was acquired by Kimberly Clark and is on the shelves under the Poise brand 

ProVate is a prescription (Rx) only home-use disposable device, intended to be used at home by women suffering from POP, who wish to have a reliable and comfortable non-surgical management of POP, without dependency on office visits for insertion, removal and cleaning of an ordinary pessary.

As with the concept of the menstrual tampon, ProVate comes ready for use in small dimensions within a personal wrapper. It is inserted intuitively by the user at her home, Into the vagina, where the applicator and the device separate, and the applicator (purple) is discarded. The device itself opens to become a ring (like a ring pessary) which supports and elevates vaginal walls.  After usage of any period, but no longer than 7 days, the user pulls the string and the device collapses to its small pre-insertion dimensions for comfortable removal and disposal at the trash. A new ProVate device may be inserted immediately following removal – or any time later, at the sole discretion of the user.

Why was ProVate developed?

The ProVate device was developed by a urogyncologist to address modern women’s needs.

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Have control

ProVate enables women with POP the ability to have control over their medical problem, being able to handle their prolapse management at home, without dependency on office visits.

Disposable device

Being a disposable only device, ProVate's usage takes away the need for cleaning of a reusable only device (e.g. existing pessaries).

Comfortably insertion

While employing the concept of the menstrual tampon, ProVate's usage enables women to comfortably insert a small size device, within an applicator, without touching herself. Likewise, removal is easy and intuitive, in small dimensions, by pulling a string
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the Freedom to decide

Exploring ProVate

CONVENIENCE

Comes wrapped, ready for use within a disposable applicator, much like a menstrual tampon applicator

USER-FRIENDLY

Self-insertion and removal by the user at home

COMFORTABLE INSERTION

Applicator allows for a smooth insertion

EASY REMOVAL FOR DISPOSAL

The device collapses to small dimensions by pulling on a string for removal and disposal

Empowering Women

How easy is it to use the ProVate device?

ProVate is made of a flexible skeleton covered by a soft elastomer. ProVate comes ready for use, in small dimensions, within a disposable applicator which enables the user to comfortably insert it into the vagina, much like with the concept of a menstrual tampon. Pressing the plunger deploys the device into its full ring size, and then separates it from the applicator, which is then smoothly and painlessly removed and disposed of. Removal of the ProVate device, for any reason, is very easy. A pull on the string collapses ProVate into its compacted which comes out of the vagina for disposal
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Will ProVate be suitable for me?

ProVate devices come in 6 different sizes, to accommodate various vaginal dimensions. it requires an initial office visit for fitting and educating the user as to how to use the device, and later another confirmatory visit, either at the office or a telehealth visit.

How does ProVate work, and how long can I keep it in?

Once fully deployed in the vagina, ProVate provides support to various vaginal walls, and mechanically prevents pelvic organs descent and potential further prolapse. You may keep it in use for up to 7 days before replacing. This means you may remove the device, for any reason, and at any time – but do not use it for more than 7 days. The used device is disposed of, hence there is no cleaning process involved.

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Best Novel Therapies

ProVate has been tested is several clinical trials and its efficacy and safety for use have been well demonstrated, regardless of other positive results concerning other studied factors. The ProVate device has clearance for marketing in the US and in Europe, and results from the clinical studies have been presented in many clinical meetings. In a meeting of the American Urogynecological Society meeting, the device and the study presented, were awarded as the best clinical therapy.

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What do I need to do to start using the ProVate device?

Make an appointment with your GYN HCP to see if the ProVate device is suitable for you.
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Your freedom to decide

What steps will be taken at the HCP's office?

When your HCP confirms the need for using the ProVate device, the following steps will be taken:
01

Woman arrives at the provider’s office

1. Vaginal digital size assessment of pessary ring
2. Provider inserts the appropriate ProVate size into the vagina and assesses adequacy
3. If needed – a larger or a smaller size may be used

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02

Provider instructs patient how to insert ProVate according to the IFU

1. Patient inserts a ProVate device into her vagina and also removes the device
2. Patient inserts another ProVate device into the vagina and goes home with a device in-situ

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03

Patient also takes home a larger size ProVate device and a smaller one

In case of expulsion – she inserts a larger size device, and if uncomfortable – a smaller size device

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04

A TeleHealth visit is conducted within 5-7 days

1. Patient receives a prescription for 3 months via the EMR
2. Patient will receive every 3 months a package of 20 devices via Specialty Pharma

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Watch the 2.5 minutes animation on ProVate

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Contact

Please contact us with any question

ConTIPI Medical

contact@contipi.com

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