The Development and Application of an Intelligent Diagnosis and Treatment System for Pelvic Floor Dysfunction in Elderly Women
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Enrollment
- 300
- Locations
- 1
- Primary Endpoint
- Surface Electromyography Data
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Investigator, Outcomes Assessor)
Masking Description
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.
Eligibility Criteria
- Ages
- 60 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
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
Outcomes
Primary Outcomes
Surface Electromyography Data
Time Frame: Baseline, Month 3, Month 6, Month 12
Pelvic floor muscle(PFM) surface electromyography (EMG) testing is one method for assessing the quantity and quality of PFM function. The electromyograms regarding the contraction and relaxation capacity of the PFM will be recorded simultaneously from electrode probes on perineum and adjacent muscles.
Modified Oxford Scale (MOS)
Time Frame: Baseline, Month 3, Month 6, Month 12
The modified Oxford scale(Mos) is presently the gold standard used to assess pelvic floor muscle strength. Digital assessment of pelvic floor muscle contraction will be performed by the examiner inserting the index and middle fingers approximately 4 cm into the vagina (only the index finger in the case of very narrow hiatus) and palpating the puborectalis muscle at each side of the vagina during contraction. The Modified Oxford Scale (MOS) was used to rate pelvic floor muscle contraction on a scale of 0-5: 0 = no contraction; 1 = minor muscle 'flicker'; 2 = weak muscle contraction; 3 = moderate muscle contraction; 4 = good muscle contraction and 5 = strong muscle contraction.
Secondary Outcomes
- The score of Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI SF)(Baseline, Month 3, Month 6, Month 12)
- The score of the Pelvic Floor Distress Inventory (PFDI-20)(Baseline, Month 3, Month 6, Month 12)
- Subjective staging used Pelvic Organ Prolapse Quantification (POP-Q) System(Baseline, Month 3, Month 6, Month 12)