Development and Implementation of a Remote Monitoring and Feedback System for Female Pelvic Floor Rehabilitation Training Based on Artificial Intelligence

Pelvic Floor Rehabilitation Training Prescription Label: An individualized training prescription generated by aggregating a comprehensive profile of maternal information through AI and applying data deep-mining algorithms, aiming to deliver targeted and precise interventions for mothers at different behavioral stages.PFMT Error-Correction Feedback Program: A program that identifies abnormal pelvic floor muscle contractions in mothers by and analyzing electromyographic (EMG) signals from the abdominal muscles, gluteal muscles, and other muscle groups, and develops an error-correction program with text, visual, and audio prompts. Maternal Mobile APP: A system developed with functions including self-management, health education, nurse-patient communication, and remote monitoring. Preliminary Clinical Application: A randomized controlled trial (RCT) will be conducted in women at 6-8 weeks postpartum using the remote monitoring and feedback system for pelvic floor rehabilitation training. The clinical application effects will be evaluated to achieve full-process assessability, guidance, and supervision of postpartum PFMT, thereby improving maternal participation, compliance, and correctness in PFMT.

Study Overview

• Status: Completed
• Conditions: Pelvic Floor Rehabilitation Training
• Intervention / Treatment: Behavioral: a remote monitoring and feedback system for female pelvic floor rehabilitation training based on artificial intelligence

• Study Type: Interventional
• Enrollment (Actual): 96
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Beijing Municipality
    • Beijing, Beijing Municipality, China, 100730
      • Peking Union Medical College Hospital, Chinese Academy of Medical Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Age ≥ 18 years;
• Women who underwent pelvic floor screening at our hospital's Pelvic Floor Center at 6-8 weeks postpartum;
• Have normal cognitive ability and are able to use mobile apps or other means to access information;
• Voluntarily participate in the study and sign the informed consent form.

Exclusion Criteria:

• Women with contraindications to pelvic floor muscle training (e.g., vaginal or rectal bleeding, etc.);
• Those with psychiatric disorders that preclude cooperation with this study;
• Those who have difficulty adhering to follow-up visits.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: App-Based Remote Pelvic Floor Rehabilitation; The researchers assisted the participants in downloading the user-side APP, and provided and instructed them on the use of the home-based pelvic floor rehabilitation device. On the healthcare provider side, remote monitoring of the participants' compliance with pelvic floor muscle training was conducted, and compensatory errors were corrected individually. The training regimen was intelligently adjusted based on real-time data, and the participants completed daily check-ins and questionnaire assessments via the APP.	Behavioral: a remote monitoring and feedback system for female pelvic floor rehabilitation training based on artificial intelligence; The researchers assisted the participants in downloading the user-side APP, and provided and instructed them on the use of the home-based pelvic floor rehabilitation device. On the healthcare provider side, remote monitoring of the participants' compliance with pelvic floor muscle training was conducted, and compensatory errors were corrected individually. The training regimen was intelligently adjusted based on real-time data, and the participants completed daily check-ins and questionnaire assessments via the APP.
No Intervention: Routine Home-Based Pelvic Floor Rehabilitation; The routine home-based rehabilitation nursing model implemented at our hospital's Pelvic Floor Center was adopted, encompassing health education, nurse-patient communication, screening appointment scheduling, and follow-up monitoring.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pelvic Floor Muscle Contractility	Pelvic floor muscle strength	Baseline, 6 weeks post-intervention, and 12 weeks post-intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Type I and Type II pelvic floor muscle fiber strength	Physiological indicators of pelvic floor muscle pressure were assessed using a pelvic floor muscle pressure measurement device. The parameters included: (1) Type I muscle fiber strength and fatigue - representing slow-twitch fibers responsible for sustained resting tone and endurance; (2) Type II muscle fiber strength and fatigue - representing fast-twitch fibers responsible for rapid, forceful contractions; and (3) maximum vaginal contraction pressure - reflecting the overall maximal voluntary contraction capacity of the pelvic floor muscles.	Baseline, 6 weeks post-intervention, and 12 weeks post-intervention
Pelvic Floor Distress Inventory (PFDI-20) score	Pelvic floor dysfunction-related symptoms were assessed using the Pelvic Floor Distress Inventory-20 (PFDI-20). The total score ranges from 0 to 300, with higher scores indicating greater symptom distress and more severe pelvic floor dysfunction.	Baseline, 6 weeks post-intervention, and 12 weeks post-intervention
Quality of life score	Quality of life was assessed using the Incontinence Impact Questionnaire-7 (IIQ-7). The total score ranges from 0 to 100, with higher scores indicating a greater negative impact of urinary incontinence on daily activities, emotional well-being, and social functioning, reflecting poorer quality of life.	Baseline, 6 weeks post-intervention, and 12 weeks post-intervention
Adherence to pelvic floor muscle training	Adherence to pelvic floor muscle training (PFMT) was monitored and recorded through the mobile APP. Adherence was defined as the percentage of prescribed training sessions actually completed over the 12-week intervention period. Participants were conside	Baseline, 6 weeks post-intervention, and 12 weeks post-intervention

Collaborators and Investigators

• Sponsor: Peking Union Medical College Hospital

Study record dates

Study Major Dates

• Study Start (Actual): October 19, 2025
• Primary Completion (Actual): March 29, 2026
• Study Completion (Actual): March 29, 2026

Study Registration Dates

• First Submitted: July 5, 2026
• First Submitted That Met QC Criteria: July 9, 2026
• First Posted (Actual): July 13, 2026

Study Record Updates

• Last Update Posted (Actual): July 13, 2026
• Last Update Submitted That Met QC Criteria: July 9, 2026
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: I-24PJ2211

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No