152
Participants
Start Date
May 20, 2021
Primary Completion Date
December 8, 2022
Study Completion Date
December 8, 2022
Laboratory tests: blood and faeces tests
To be performed at V2
Gynaecological and proctological examinations
To be performed at V1 (Examination with a gynaecological speculum, Bimanual examination, Rectal examination, and Anoscopy)
3-D Endoanal Ultrasound
To be performed at V1 (as a reference and for group assignment)
ONIRY measurement
To be performed at V2 (the electrical impedance of anal sphincter muscles will be measured)
High-resolution anorectal manometry
To be performed at V3
ECG
To be performed at V1 and V2 (for safety reasons)
Complejo Asistencial Universitario de Leon, León
Fakultni nemocnice, Brno
Ustav pro peci o matku a dite, Prague
FEMINITY Praktyka Lekarska dr Małgorzata Uchman-Musielak, Warsaw
Gynekologicko-pôrodnícka klinika Nemocnica AGEL Košice-Šaca a.s., Košice
Lead Sponsor
National Center for Research and Development, Poland
OTHER
OASIS Diagnostics S.A.
INDUSTRY