Pelvic Floor Rehabilitation TrainingNCT07697508

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

A study testing a remote monitoring and feedback system for female pelvic floor rehabilitation training based on artificial intelligence in people with Pelvic Floor Rehabilitation Training, run by Peking Union Medical College Hospital at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and older, women onlyHealthy volunteers can take part
Conditions the study is for: Pelvic Floor Rehabilitation Training
What is being tested?: a remote monitoring and feedback system for female pelvic floor rehabilitation training based on artificial intelligence
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 96 participants
Where: 1 siteChina
Study dates: 19 Oct 2025to 29 Mar 2026
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
Women only
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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.

Who cannot join

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.

Trial locations and contacts

1 site in 1 country.

China1 site

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

Other trials in China

About this study

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.

Conditions: Pelvic Floor Rehabilitation Training
Being tested: a remote monitoring and feedback system for female pelvic floor rehabilitation training based on artificial intelligence

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

Study groups in NCT07697508
Study group	Role	What they receive
App-Based Remote Pelvic Floor Rehabilitation	Experimental	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. Receives: Behavioral: a remote monitoring and feedback system for female pelvic floor rehabilitation training based on artificial intelligence
Routine Home-Based Pelvic Floor Rehabilitation	No intervention	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 being measured

The primary outcome is the main question the study is designed to answer.

Pelvic Floor Muscle Contractility
Pelvic floor muscle strength
Measured: Baseline, 6 weeks post-intervention, and 12 weeks post-intervention

Secondary outcomes (4)

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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: Baseline, 6 weeks post-intervention, and 12 weeks post-intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

19 Oct 202529 Mar 2026

First posted13 Jul 2026
Study start19 Oct 2025
Primary completion29 Mar 2026
Study completion29 Mar 2026

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Pelvic Floor Rehabilitation TrainingStudies of the same condition, open and under way.
More trials run by Peking Union Medical College HospitalThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Health services research
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 96 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07697508
Sponsor's protocol ID: I-24PJ2211
Status last verified: Oct 2023
First submitted: 5 Jul 2026
Last updated: 13 Jul 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Pelvic Floor Rehabilitation Training trials

Study at a glance

From the registry record, last updated by the sponsor on 13 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Development and Implementation of a Remote Monitoring and Feedback System for Female Pelvic Floor Rehabilitation Training Based on Artificial Intelligence
ClinicalTrials.gov ID: NCT07697508
Acronym / sponsor ID: I-24PJ2211
Conditions: Pelvic Floor Rehabilitation Training
Study type: Interventional
Recruitment status: Completed
Enrolment: 96 participants (actual)
Lead sponsor: Peking Union Medical College HospitalUniversity, hospital or other
Study start: 19 Oct 2025 (actual)
Primary completion: 29 Mar 2026 (actual)
Study completion: 29 Mar 2026 (actual)
First posted: 13 Jul 2026 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Health services research
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
App-Based Remote Pelvic Floor Rehabilitation	Experimental	Behavioral: a remote monitoring and feedback system for female pelvic floor rehabilitation training based on artificial intelligenceThe 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.
Routine Home-Based Pelvic Floor Rehabilitation	No intervention	–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.

Who may qualify

Ages: 18 years and older
Sex: Female only
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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.

Key exclusion criteria (3 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
a remote monitoring and feedback system for female pelvic floor rehabilitation training based on artificial intelligenceThe 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.	Behavioural	App-Based Remote Pelvic Floor Rehabilitation

Primary outcome

Pelvic Floor Muscle Contractility
Time frame: Baseline, 6 weeks post-intervention, and 12 weeks post-intervention
Pelvic floor muscle strength

4 secondary outcomes

Type I and Type II pelvic floor muscle fiber strength
Time frame: Baseline, 6 weeks post-intervention, and 12 weeks post-intervention
Pelvic Floor Distress Inventory (PFDI-20) score
Time frame: Baseline, 6 weeks post-intervention, and 12 weeks post-intervention
Quality of life score
Time frame: Baseline, 6 weeks post-intervention, and 12 weeks post-intervention
Adherence to pelvic floor muscle training
Time frame: Baseline, 6 weeks post-intervention, and 12 weeks post-intervention

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2026.
Individual participant dataSharing planned: No

Related trials for Pelvic Floor Rehabilitation Training

Not yet recruiting
Feasibility of Resisted Expiratory Muscle Training for Females Assigned at Birth With Stress Urinary Incontinence: A Pilot Study
Stress Urinary Incontinence
RecruitingPhase 2
Multimodal Prehabilitation and Rehabilitation for Men Undergoing Robot-Assisted Radical Prostatectomy
Erectile Dysfunction Following Radical Prostatectomy, Prostate Cancer
Recruiting
Effects Of Core Canister Training in Pregnant Women With History of Gestational Diabetes Mellitus
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Not yet recruiting
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pelvic Floor Muscle Contractility (time frame: Baseline, 6 weeks post-intervention, and 12 weeks post-intervention). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07697508.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jul 2026.