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The study includes five (5) main stages: Screening, Enrollment, Size fitting, Usage and Termination.
Subject screening will be held during visit one (1) and visit two (2) at the clinic.
Initiation and Size fitting:
All eligible subjects will undergo size fitting by a gynecologist / urogynecologist, during visit 2, to find the suitable size for her. The subject will use the ProVATE device of the chosen size at the clinic vicinity for about one (1) hour and for 40-80 hours at her home environment, to confirm that the chosen size is appropriate for the user. Each usage will be followed by a vaginal examination. In case the investigator will determine that the subject should be fitted with a different size of the ProVATE device the subject will repeat this stage with a different device size until the suitable size is confirmed by the investigator.
Usage:
The subject will use the ProVATE device for at least 28 days during a 45 days period, at her home environment, and fill a usage diary. Each device will be used for at least 24 hours. At least one (1) follow-up phone call will be held with the subject per a week. After 14 usage days or following at least two (2) usages (the latest of them) the subject will be scheduled for vaginal examination at the clinic (visit four (4)).
End Of Use At the end of use the subject will return to the clinic (visit five (5)) for a vaginal examination and additional activities.
The following questionnaires will be filled at baseline and end of study: Quality Of Life (QoL) and POP symptoms. Satisfaction and Ease Of Use questionnaires will be filled at the end of use (visit 5) Up to four (4) ProVATE device models will be tested in this study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ProVATE vaginal pessary | Experimental | The ProVATE device is a disposable, single-use, vaginal pessary for the management of Pelvic Organ Prolapse ("POP"). The ProVATE device is similar to other ring pessaries currently on the market. Its features allow for easy and comfortable insertion and removal by the user herself at her home environment. The ProVATE device is provided in six (6) different sizes and is intended for prescription use only. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ProVATE vaginal pessary | Device |
|
| Measure | Description | Time Frame |
|---|---|---|
| Degree of prolapse and POP symptoms following ProVATE device insertion, compared to the degree of prolapse prior to the insertion of the ProVATE device (by vaginal examination) | At day 1 - baseline, and following at least 28 and up to 45 days of using the ProVATE vaginal pessary |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Site 01 | Herzliya | Israel | ||||
| Site 02 |
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| ID | Term |
|---|---|
| D056887 | Pelvic Organ Prolapse |
| ID | Term |
|---|---|
| D011391 | Prolapse |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Herzliya |
| Israel |
| Site 03 | Ramat HaSharon | Israel |