ProVate:
The next generation
of self-management
for pelvic organ prolapse

ProVate is a single-use, disposable, self-managed option for women to treat their pelvic organ prolapse. Each ProVate device is intended to be used for up to 7 days. Unlike traditional pessaries, ProVate gives women the power to manage POP on their own terms.1-3

ProVate is available by prescription only after an initial fitting by a qualified health care provider.

Unmet Need
Clinical results
Prescribing ProVate
Request a representative

 Do not prescribe ProVate to patients who2:

  • Have a severely atrophic vagina
  • Had unusual or unexpected vaginal bleeding within the last 6 months
  • Have a vaginal infection or a symptomatic urinary tract infection
  • Have vaginal wall trauma (eg, laceration or mesh erosion)
  • Had vaginal surgery within the past 3 months
  • Are pregnant
  • Are under the age of 21

For more information, please see the HCP IFU.

The unspoken burden of pelvic organ prolapse

  • Approximately 50 percent of women will develop POP4
  • Many patients let their POP progress without bringing it up to their health care providers because they are uncomfortable talking about it5
    • Some patients may think that POP is just another symptom of childbirth, when in reality it is a very treatable condition6
    • Many women refrain from disclosing any symptoms of pelvic floor dysfunction, including urinary incontinence, POP, and fecal incontinence, with their health care providers5,6

Continue to have regular conversations with your patients about POP.

POP-Q staging with ProVate: Demonstrated to safely reduce prolapse*

  • A reduction of at least 2 POP-Q stages was observed in all patients who completed the study while using ProVate1†
    • Primary objective efficacy endpoint: the proportion of participants with at least a 1-stage reduction in the POP-Q stage at visit 5, was met and shown to be 100 percent of patients who completed the study‡

Secondary subjective endpoints:

  • Improvement in QoL assessed using the modified PFDI-20 and modified PFIQ-7 questionnaires1
  • Improvement of POP symptoms assessed by an author-compiled POP symptoms alleviation questionnaire1
  • Participant satisfaction with the device evaluated by an author-compiled questionnaire1
  • A demonstrated reduction was achieved in all items on both the modified PFDI-20 and PFIQ-7 QoL questionnaires (implying an improvement in QoL regarding POP)1,2

This was a statistically powered and hypothesis-driven prospective, interventional, multicenter, single-arm, open-label, self-controlled, home-use study of 47 patients (full analysis group) for 28-45 usage days that assessed improvement in prolapse stage using the POP symptoms alleviation score.1,2

Safety was evaluated by recording the rate and incidence of AEs in a daily diary1

  • A total of 33 AEs were recorded during the study, of which 21 were potentially device related. All potentially device-related events were considered mild and non-serious, and all resolved spontaneously2
  • Of the 21 potentially device-related AEs, there were 5 cases of spotting, 4 cases of discomfort, 4 cases of pain, 2 cases of vaginal burning, and 1 complaint each of De novo stress urinary incontinence, vaginal discharge, poor urinary stream, vulvar burning, frequent urination, and urinary retention2

For further details and results, please see Appendix D of the HCP IFU.

*A prospective, interventional, multicenter, single-arm, open-label, self-controlled, home-use study of 52 patients over 92 use cycles assessed subjective efficacy using the POP symptoms alleviation score.1
†95% exact CI, 96.07-100.1
‡For the per-protocol group, defined as all participants from the full analysis set who used the study device models for at least 20 days, with no significant protocol deviation.1
AE, adverse event; PFDI-20, Pelvic Floor Disability Index; PFIQ-7, Pelvic Floor Impact Questionnaire; POP, pelvic organ prolapse; POP-Q, Pelvic Organ Prolapse Quantification system; QoL, quality of life.

ProVate does not alter vaginal microbial health in a clinically significant manner5

In a vaginal microflora clinical trial, ProVate demonstrated comparable outcomes to a commercially available ring pessary in terms of vaginal microbial health. The use of either device resulted in a relatively low rate of vaginal infections. Both devices successfully met the primary endpoint.

Study design:

  • An interventional, prospective, multicenter, open-label, randomized, controlled, crossover, home-use noninferiority trial tested ProVate and an existing ring pessary (control) in a sequential crossover fashion
  • The study included 59 patients with an average age of 64.5 years. All of the patients had been diagnosed with POP Stages 2 to 4, according to the POP-Q scale
  • Participants were divided into 2 groups
  • Results were assessed during vaginal examinations and study visits, as well as from entries in a patient use diary

Results:

  • Failure criteria were a significant change in 4 key microorganisms—Lactobacillus spp., Gardnerella vaginalis, Candida morphotypes, or S aureus, where a significant change (“failure criterion”) was defined as either: a Nugent score ≥7 or >1 scale unit increase in S aureus or Candida morphotype; bothersome vaginal symptoms; or vaginal symptoms requiring treatment
  • The failure rate for both ProVate and the control was 15.5 percent
    • Patients used 383 ProVate devices over 1647 days and 1 new control device throughout the study
  • In the control group, 2 patients (3.4 percent) had bothersome vaginal complaints, and 1 (1.7 percent) had a vaginal infection. No such cases were observed in the ProVate group

ProVate does not cause meaningful changes in the vaginal microflora that may cause infection.5

For further details and results, please see Appendix D of the HCP IFU.

How to fit and prescribe ProVate2

For more details on sizing and fitting ProVate, please see full instructions in the HCP IFU.

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

.cls-1 { fill: #bba0cd; } .cls-2 { fill: #682c90; }
01

Choosing the right size

- Once your patient has been diagnosed with POP, an initial size fitting should be performed in office by a qualified health care provider using a ProVate Support

- Determine the size you think is appropriate based on an initial vaginal exam

- Following a successful size fitting, patients should be instructed how to use the device themselves
.cls-1 { fill: #bba0cd; } .cls-2 { fill: #682c90; }
02

Patient at-home trial

- Patients will be provided another ProVate support in the size selected during the consultation. This will give them the option to try insertion and removal herself

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

.cls-1 { fill: #682c90; }
03

Follow up and prescription fulfillment

- Patients should schedule another appointment for size confirmation within 3 to 6 days (no later than 7 days)

- Once an appropriate size is decided upon, the prescription can be sent to our specialty pharmacy to be fulfilled. Patients can order their ProVate Supports to ship directly to their house

 

It is important to remember that it may take more than 1 visit to determine the appropriate size. Patients may need to return multiple times for resizing.

Please note that some patients cannot retain a pessary at all due to the severity of their prolapse. It may take several trials of various sizes to arrive at this conclusion.

Setting expectations with your patients for ongoing treatment management

Once an appropriate size is selected, the prescription can be sent to Eagle Pharmacy to be fulfilled.

  • Eagle Pharmacy will reach out to your patients directly to register them
  • They will work directly with your patients to fulfill their prescription and access ProVate

Please see the Healthcare Provider Instructions for Use (IFU) for full details on how to properly fit a patient for the appropriate ProVate Support.

Download the IFU

Contact us for more information

All fields required unless marked optional.

    References: 1. Ziv E, Erlich T. Novel, disposable, self-inserted, vaginal device for the non-surgical management of pelvic organ prolapse: efficacy, safety, and quality of life. BMC Womens Health. 2022;22(1):459. doi:10.1186/s12905-022-02057-6 2. HCP Instructions for Using ProVate Device. ConTIPI Medical. Updated April 2022. 3. Hooper GL, Moynihan L, Leegant A, et al. Vaginal pessary use and management for pelvic organ prolapse. Urogynecology (Phila). 2023;29(1):5-20. doi:10.1097/SPV.0000000000001293 4. Carroll L, O’ Sullivan C, Doody C, Perrotta C, Fullen B. Pelvic organ prolapse: the lived experience. PLoS One. 2022;17(11):e0276788. doi:10.1371/journal.pone.0276788 5. Ziv E, Keller N, Erlich T. Vaginal microflora following the use of a disposable home-use vaginal device and a commercially available ring pessary for pelvic organ prolapse management: a randomized controlled trial. Arch Gynecol Obstet. 2024;309(2):571-579. doi:10.1007/s00404-023-07260-w 6. McLeod JL, Lee PE. Pelvic organ prolapse. CMAJ. 2023;195(30):E1013. doi:10.1503/cmaj.230089

    This site is intended for US health care professionals only

    HCP

    Please select:

    I am a patient or caregiver

    I am a health care professional

    This will close in 0 seconds

    Skip to content