Mar 17, 2023
Fecobionics Test in Normal Subjects
- Yanmin Wang1,
- Hans Gregersen1
- 1California Medical Innovations Institute
Protocol Citation: Yanmin Wang, Hans Gregersen 2023. Fecobionics Test in Normal Subjects . protocols.io https://dx.doi.org/10.17504/protocols.io.5qpvor1ybv4o/v1
License: This is an open access protocol distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited
Protocol status: Working
We use this protocol and it's working
Created: March 17, 2023
Last Modified: March 17, 2023
Protocol Integer ID: 78988
Keywords: Fecobionics, anorectal
Funders Acknowledgement:
NIH SPARC
Grant ID: OT2OD028203
Abstract
It is the protocol of Fecobionics test in normal subjects. Briefly, the device will be inserted into participants' rectum and several motions (cough, squeeze, straining, push) will be done. After the motions, the bag will be inflated and the participant may have different sensations during inflation. Data will be recorded and shown in real time.
Make sure the participant is eligible to do the study, and make sure he/she understands the study and has signed the informed consent form.
Ask the subject to empty bladder and rectum before the test.
Participant changes clothes and lies on left side.
Calibrate the Fecobionics device and make sure the transmission signal is good.
Fully lubricate Fecobionics device. Insert device gently into rectum, following a finger examination.
Participant moves to commode, in sitting position. Wait up to 5 mins until pressure data is stable.
Ask the participant to cough twice, with 15-30 seconds in between.
Ask the participant to squeeze three times, 5 seconds for each time, and 15-30 seconds in between.
Ask the participant to do a long squeeze that lasts 30 seconds.
Ask the participant to do a straining (contract both abdominal and anal muscles) that lasts 20 seconds.
Ask the participant to push three times, 15 seconds for each time, and 30 seconds in between.
Inflate the balloon with warm saline. Ask the participant to report sensations.
Stop inflating when the participant feels urge, or the maximum volume (100ml) is reached.
Detach the filling tube and give the participant privacy to defecate. If the participant cannot defecate Fecobionics in 3 minutes, withdraw it manually by pulling the thread attached to the device.
Test complete. Save data and clean up.