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

The Development and Application of an Intelligent Diagnosis and Treatment System for Pelvic Floor Dysfunction in Elderly Women

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 Overview

• Status: Recruiting
• Conditions: Urinary Incontinence; Pelvic Organ Prolapse; Diagnosis
• Intervention / Treatment: 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
• Enrollment (Estimated): 300
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Min Li, Ph.D.; Phone Number: +8613811526308; Email: mindy99999@126.com

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100005
      • Recruiting
      • Beijing Hospital
      • Contact: Yue Yu, M.D.; Phone Number: +8618962068088; Email: joyyu.119@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Procedure: 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.
Active Comparator: Standard training program; Subjects in the control group(CG) will accept pelvic floor muscle training according to the handbook or oral guidance	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Modified Oxford Scale (MOS)	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.	Baseline, Month 3, Month 6, Month 12
Surface Electromyography Data	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.	Baseline, Month 3, Month 6, Month 12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The score of Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI SF)	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.	Baseline, Month 3, Month 6, Month 12
The score of the Pelvic Floor Distress Inventory (PFDI-20)	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.	Baseline, Month 3, Month 6, Month 12
Subjective staging used Pelvic Organ Prolapse Quantification (POP-Q) System	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).	Baseline, Month 3, Month 6, Month 12

Collaborators and Investigators

• Sponsor: Beijing Hospital
• Investigators: Study Chair: Mi Li, Ph.D., Beijing Hospital

Study record dates

Study Major Dates

• Study Start (Actual): April 30, 2024
• Primary Completion (Estimated): August 31, 2025
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: April 10, 2024
• First Submitted That Met QC Criteria: April 16, 2024
• First Posted (Actual): April 18, 2024

Study Record Updates

• Last Update Posted (Actual): July 3, 2024
• Last Update Submitted That Met QC Criteria: June 30, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: Urinary incontinence; Pelvic floor dysfunction; Pelvic floor muscle; Intelligent diagnosis and treatment system; Elderly female
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Pathologic Processes; Urologic Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Urination Disorders; Pathological Conditions, Anatomical; Elimination Disorders; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Disease; Urinary Incontinence; Prolapse; Pelvic Organ Prolapse; Enuresis
• Other Study ID Numbers: 2023BJYYEC-217-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Data obtained through this study may be provided to qualified researchers with academic interest in pelvic floor muscle dysfunction. Data or samples shared will be coded, with no protected health information (PHI) included. Approval of the request and execution of all applicable agreements (i.e. a material transfer agreement) are prerequisites to the sharing of data with the requesting party.
• IPD Sharing Time Frame: Data requests can be submitted starting 12 months after article publication and the data will be made accessible for up to 24 months. Extensions will be considered on a case-by-case basis.
• IPD Sharing Access Criteria: Access to trial individual participant data (IPD) can be requested by qualified researchers engaging in independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA). For more information or to submit a request, please contact mindy99999@126.com.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No