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

Not Applicable

Recruiting

• Conditions: Diagnosis; Urinary Incontinence; Pelvic Organ Prolapse
• Interventions: Procedure: Standard pelvic floor muscle training(PFMT) program; Procedure: Personalized pelvic floor rehabilitation program generated by the intelligent diagnosis and treatment system.

• Registration Number: NCT06372340
• Lead Sponsor: Beijing Hospital

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-01
• Study First Submitted: 2024-04-10
• Study First Submitted QC: 2024-04-16
• Study First Posted: 2024-04-18
• Study Start: 2024-04-30
• Last Update Submitted: 2024-06-30
• Last Update Posted: 2024-07-03
• Primary Completion: 2025-08-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 300

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard training program	Standard pelvic floor muscle training(PFMT) program	Subjects in the control group(CG) will accept pelvic floor muscle training according to the handbook or oral guidance
Supervised and individualized pelvic floor muscle training	Personalized pelvic floor rehabilitation program generated by the intelligent diagnosis and treatment system.	Subjects in the experimental group (EG) will accept individualized pelvic floor muscle training under the introduction of skilled clinicians.

Primary Outcome Measures

Name	Time	Method
Surface Electromyography Data	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)	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 Outcome Measures

Name	Time	Method
The score of Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI SF)	Baseline, Month 3, Month 6, Month 12	The Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI SF) is a questionnaire for evaluating the frequency, severity and impact on quality of life (QoL) of urinary incontinence in research and clinical practice across the world. It is used to screen for incontinence, to obtain a brief yet comprehensive summary of the level, impact and perceived cause of symptoms of incontinence. The ICIQ-UI SF score ranges from 0 to 21. A score of zero means no leakage of urine and no affection on quality of life.
The score of the Pelvic Floor Distress Inventory (PFDI-20)	Baseline, Month 3, Month 6, Month 12	The Pelvic Floor Distress Inventory (PFDI-20) is a patient-reported outcome measures that is often used in clinical practice and clinical trials to assess the distress caused by the presence of pelvic floor dysfunction. It assesses the distress of pelvic organ prolapse (POP), anorectal and urinary symptoms in three subscales, respectively. PFDI-20 summary score ranges from 0 to 300. It is interpreted as the higher the score, the worse the distress.
Subjective staging used Pelvic Organ Prolapse Quantification (POP-Q) System	Baseline, Month 3, Month 6, Month 12	The POP-Q describes descent of the anterior and posterior vaginal wall and uterine cervix or, after hysterectomy, the vaginal vault, relative to the hymen on maximal Valsalva maneuver. In clinical practice, the POP-Q is often used to stratify findings into stages - Stage 0 (normal) and Stages 1-4 (prolapse).

Trial Locations

Locations (1)

Beijing Hospital; 🇨🇳 Beijing, Beijing, China