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

Beijing Hospital

Status: Enrolling

Conditions: Diagnosis; Pelvic Organ Prolapse; Urinary Incontinence

Treatments: Procedure: Personalized pelvic floor rehabilitation program generated by the intelligent diagnosis and treatment system.; Procedure: Standard pelvic floor muscle training(PFMT) program

Study type: Interventional

Funder types: Other

Identifiers

NCT06372340

2023BJYYEC-217-01

Details and patient eligibility

About

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.

Enrollment: 300 estimated patients

Sex: Female

Ages: 60+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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300 participants in 2 patient groups

Supervised and individualized pelvic floor muscle training

Experimental group

Description:

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

Treatment:

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

Standard training program

Active Comparator group

Description:

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

Treatment:

Procedure: Standard pelvic floor muscle training(PFMT) program