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OpenTrials
Completed

NCT Number: NCT07697508

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.

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Key information

Conditions

Pelvic Floor Rehabilitation Training

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Peking Union Medical College Hospital, Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, 100730, China

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

a remote monitoring and feedback system for female pelvic floor rehabilitation training based on artificial intelligence

Behavioral

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.

Primary outcomes

  1. Pelvic Floor Muscle Contractility

    Time frame: Baseline, 6 weeks post-intervention, and 12 weeks post-intervention

    Pelvic floor muscle strength

Secondary outcomes

  1. Type I and Type II pelvic floor muscle fiber strength

    Time frame: Baseline, 6 weeks post-intervention, and 12 weeks post-intervention

    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.

  2. Pelvic Floor Distress Inventory (PFDI-20) score

    Time frame: Baseline, 6 weeks post-intervention, and 12 weeks post-intervention

    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.

  3. Quality of life score

    Time frame: Baseline, 6 weeks post-intervention, and 12 weeks post-intervention

    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.

  4. Adherence to pelvic floor muscle training

    Time frame: Baseline, 6 weeks post-intervention, and 12 weeks post-intervention

    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

Sponsors and collaborators

Lead sponsor

Peking Union Medical College Hospital

Other

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jul 13, 2026
Registry last updated
Jul 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.