Comparison Between Home-based Wearable Device and Supervised PFMT on SUI/MUI

NACompletedINTERVENTIONAL
Enrollment

500

Participants

Timeline

Start Date

March 30, 2022

Primary Completion Date

November 1, 2023

Study Completion Date

November 1, 2024

Conditions
Stress Urinary Incontinence
Interventions
DEVICE

PFMT with device

The wearable PFMT device (XFT-0010CK) is made by two parts. One part is the screen device which is able to show the real-time vaginal resting pressure and voluntary contraction pressure in units of mmHg. The other part is a vaginal air-filled probe. The two parts are combined with a thin air tube. The whole device is connected to a smartphone app by Bluetooth to record the progress of PFMT. There are two modes of the device, one is assessment mode, when it comes to the assessment mode that the device is able to assess the grade of type I and II pelvic floor muscle fiber strength by the patients themselves, the other mode is practice mode by displaying real-time visual pressure value according to the completeness of the PFMT program.

Trial Locations (1)

100730

Peking Union Medical College Hospital, Beijing

All Listed Sponsors
lead

Peking Union Medical College Hospital

OTHER