Introducing ProVate
The New Era in Pelvic Organ
Prolapse Self-Management
Exploring ProVate
ProVate - the Freedom to Decide!
CONVENIENCE
USER-FRIENDLY
COMFORTABLE INSERTION
EASY REMOVAL FOR DISPOSAL
ProVate – the new disposable self-management option for POP
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.
best technology 2017
Best Novel Therapies
Empowering Women
How easy is it to use the ProVate device?
Pelvic Organ Prolapse (POP)
Empowering Women
Are you suffering from Pelvic Organ Prolapse (POP)?
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.
Why was ProVate developed?
The ProVate device was developed by a urogyncologist to address modern women’s needs
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?
Ring Pessaries – Drawbacks & Mitigation Options
Challenges
Pain and discomfort
Solutions
Hard, durable, and large bodies
Usability cycle
Pain and discomfort
Soft and flexible
A reusable-only device
Usability cycle
Usability cycle
A disposable-only device
Manual insertion, mostly by a caregiver
Usability cycle
Insertion
Insertion by the user herself, within an applicator
Manual removal only in the large dimensions
Usability cycle
Removal
Removal by the user herself, by pulling a string, in small dimensions
~Every 3+ months by a healthcare provider
Usability cycle
Length of use
Each device should be used for up to a week
Vaginal discharge, irritation, infection, spotting, and foul smell are well-described, known adverse events
Usability cycle
Adverse events
A disposable-only device with a short usage duration
A reusable device, reused for years, require,
in most cases, dependency on clinic visits
Usability cycle
Dependency on the clinic
Device is self inserted, irrespective of time and place
Get the provate device
What do I need to do to start using the ProVate device?
Your freedom to decide
What Steps will be Taken at the Healthcare Provider's Office?
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
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
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
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