protocolSection identificationModule nctId: NCT06372340, orgStudyIdInfo id: 2023BJYYEC-217-01, briefTitle: Intelligent Diagnosis and Treatment System for Pelvic Floor Dysfunction in Elderly Women, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-30, primaryCompletionDateStruct date: 2025-08-31, completionDateStruct date: 2025-12-31, studyFirstPostDateStruct date: 2024-04-18, lastUpdatePostDateStruct date: 2024-04-18, sponsorCollaboratorsModule leadSponsor name: Beijing Hospital, class: OTHER_GOV, descriptionModule briefSummary: 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., conditionsModule conditions: Pelvic Organ Prolapse, conditions: Urinary Incontinence, conditions: Diagnosis, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NON_RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: 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., primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, maskingDescription: 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., whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 300, type: ESTIMATED, armsInterventionsModule interventions name: Personalized pelvic floor rehabilitation program generated by the intelligent diagnosis and treatment system., interventions name: Standard pelvic floor muscle training(PFMT) program, outcomesModule primaryOutcomes measure: Modified Oxford Scale (MOS), primaryOutcomes measure: Surface Electromyography Data, secondaryOutcomes measure: The score of Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI SF), secondaryOutcomes measure: The score of the Pelvic Floor Distress Inventory (PFDI-20), secondaryOutcomes measure: Subjective staging used Pelvic Organ Prolapse Quantification (POP-Q) System, eligibilityModule sex: FEMALE, minimumAge: 60 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False