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

NCT06372340 | Unknown

• 1 other identifier: 2023BJYYEC-217-01
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

Pelvic Organ Prolapse; Urinary Incontinence; Diagnosis

Keywords

Urinary incontinence; Pelvic floor muscle; Intelligent diagnosis and treatment system; Elderly female; Pelvic floor dysfunction

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• 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

Study Arms (2)

Supervised and individualized pelvic floor muscle training

EXPERIMENTAL

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.

Standard training program

ACTIVE COMPARATOR

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

Interventions

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

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.

Supervised and individualized pelvic floor muscle training

Standard pelvic floor muscle training(PFMT) program PROCEDURE

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.

Standard training program

Eligibility Criteria

• Age: 60 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- Women over 60 years old.

You may not qualify if:

• 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

Sponsors & Collaborators

• Beijing Hospital: lead

Study Sites (1)

Beijing Hospital

Beijing, Beijing Municipality, 100005, China

RECRUITING

MeSH Terms

Conditions

Pelvic Organ Prolapse; Urinary Incontinence; Disease

Condition Hierarchy (Ancestors)

Prolapse; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathologic Processes

Study Officials

• Mi Li, Ph.D.

  Beijing Hospital

  STUDY CHAIR

Central Study Contacts

Min Li, Ph.D.

CONTACT

+8613811526308; mindy99999@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: April 10, 2024
• First Posted: April 18, 2024
• Study Start: April 30, 2024
• Primary Completion: August 31, 2025
• Study Completion: December 31, 2025
• Last Updated: July 3, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• 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.
• 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.

Locations

CN (1)