Intelligent Diagnosis and Treatment System for Pelvic Floor Dysfunction in Elderly Women

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-04-30

Study Completion Date

2025-12-31

Brief Summary

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The aim of this study is to propose an intelligent diagnosis and treatment system for for pelvic floor dysfunction in elderly women. The main question it aims to answer: 1) How can the investigators find out early if older women have different pelvic floor muscle functions? 2）How can the investigators give personalized treatment plans based on differences in pelvic floor function? Participants will be assigned different training programs by the system. The investigators will compare the treatment effects and costs of older women with pelvic floor dysfunction using and not using the system. All the participants will be offered examinations for pelvic floor function and different treatments. All examinations and treatments are non-invasive.

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Detailed Description

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Conditions

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Pelvic Organ Prolapse Urinary Incontinence Diagnosis

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

The participants will be allocated to experimental group(EG) or the control group(CG). Subjects in the experimental group (EG) will receive personalized pelvic floor muscle training guidance provided by the system, whereas subjects in the control group(CG) will exercise according to the handbook or oral guidance.

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Assessments regarding pelvic floor muscle strength will be conducted by an assessor blind to treatment allocation. The assessor will go through a profound assessment training program. Due to the nature of the intervention neither participants nor care providers can be blinded to allocation, but are strongly inculcated not to disclose the allocation status of the participant at the follow up assessments. An employee outside the research team will feed data into the computer in separate datasets so that the researchers can analyse data without having access to information about the allocation.

Study Groups

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Supervised and individualized pelvic floor muscle training

Subjects in the experimental group (EG) will accept individualized pelvic floor muscle training under the introduction of skilled clinicians.

Group Type EXPERIMENTAL

Personalized pelvic floor rehabilitation program generated by the intelligent diagnosis and treatment system.

Intervention Type PROCEDURE

Utilizing machine learning to process and analyze vast amounts of previously collected data, the investigators will establish an intelligent system that can generate personalized pelvic floor exercise prescription by matching factors such as general clinical information and pelvic floor muscle strength data. The experimental group will receive tailored program, including pelvic floor muscle training with diverse intensity and frequency, electrical stimulation, magnetic stimulation, biofeedback and other treatments. The results will ultimately be compared with those taking standardized pelvic floor muscle training only.

Standard training program

Subjects in the control group(CG) will accept pelvic floor muscle training according to the handbook or oral guidance

Group Type ACTIVE_COMPARATOR

Standard pelvic floor muscle training(PFMT) program

Intervention Type PROCEDURE

Participants will be given handbooks with detailed training program: the basic regimen consists of 3 sets of 8 to 12 contractions sustained for 8 to 10 sec each, performed 3 times a day. Patients should try to do this every day and continue for at least 15 to 20 weeks.

Interventions

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Personalized pelvic floor rehabilitation program generated by the intelligent diagnosis and treatment system.

Utilizing machine learning to process and analyze vast amounts of previously collected data, the investigators will establish an intelligent system that can generate personalized pelvic floor exercise prescription by matching factors such as general clinical information and pelvic floor muscle strength data. The experimental group will receive tailored program, including pelvic floor muscle training with diverse intensity and frequency, electrical stimulation, magnetic stimulation, biofeedback and other treatments. The results will ultimately be compared with those taking standardized pelvic floor muscle training only.

Intervention Type PROCEDURE

Standard pelvic floor muscle training(PFMT) program

Participants will be given handbooks with detailed training program: the basic regimen consists of 3 sets of 8 to 12 contractions sustained for 8 to 10 sec each, performed 3 times a day. Patients should try to do this every day and continue for at least 15 to 20 weeks.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

\- Women over 60 years old.

Exclusion Criteria

* Severe pelvic organ prolapse (POP-Q stage\>III)
* History of pelvic floor surgery
* Malignant tumor in pelvic
* Allergic to nickel
* Acute inflammation of pelvic or genital tract
* Subjects who has cognitive impairment and cannot sign an informed consent

Minimum Eligible Age

60 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes