Pelvic Organ Prolapse Clinical Trial
Official title:
Pilot Study for the Evaluation of the ProVATE (ProTIPI) Pessary Designs in the Temporary Management of Pelvic Organ Prolapse (POP) in Women
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.
n/a
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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