Investigations

Call for Investigator Sites

Labour wards from selected EU countries (see below) are invited to participate in two prospective studies on burden of faecal incontinence (FI) in women after vaginal delivery

Both studies are proposed as a package: it is expected that each participating site (labour ward/birth centre) will conduct both of them

Two research studies are currently being set up by OASIS Diagnostics S.A., an innovative medical technology company based in Poland

Study 1

The first study (Study 1) is an epidemiological survey aimed to prospectively assess the burden of FI in unselected women after vaginal delivery. This study is non-interventional and focused solely on data collection:

Study initiation is planned in 3-4Q 2023 with 6 months of recruitment

Participants will be followed up for 1 year and optionally 2 years via 2 or 3 follow-up telephone calls (at 6 months/1 year and optionally 2 years after the delivery)

Main inclusion criterion is a woman after the vaginal delivery who provided written informed consent

Total number of participants to be recruited in the study: 1000

Study to be conducted in approx. 7 EU countries (currently sites in Germany, Austria, Czech Republic, Spain, Slovakia, and Denmark are sought)

Study 2

Completion of recruitment for Study 1 will be followed by the second study (Study 2): a Post-marketing Clinical Follow up (PMCF) of the ONIRY medical device. The objective of this study will be to evaluate the incidence and burden of FI in women having given vaginal birth at labour wards in which ONIRY is routinely used for detection of OASI in the postpartum period.

Study initiation is planned in 1-2Q 2024 with 6 months of recruitment

Main inclusion criterion: same as Study 1

Participant follow-up: same as Study 1

Total number of participants to be recruited in the study: same as Study 1 (1000)

Study to be conducted in same sites as Study 1

This is a presentation of a healthcare technology in development, intended only for a closed audience, not for distribution. This is not an advertisement in any way or under any jurisdiction.

ONIRY Device

The ONIRY device, developed by OASIS Diagnostics, is expected to be introduced to the market at the end of 2023 as a rapid screening tool for obstetric anal sphincter injuries (OASI). Click here one-minute video demonstrating the use case for ONIRY device.

If you are interested in conducting both studies, please write back to info@twmaresearch.com. You will be sent a non-disclosure agreement (NDA), followed by a more detailed information including the outline for both studies together with a feasibility questionnaire.

This information is related to a healthcare technology in development, intended only for a closed audience of healthcare practitioners, in the context of scientific research, not for distribution. This is not an advertisement in any way or under any jurisdiction.