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

Urinary Incontinence Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06372340
• Other study ID #: 2023BJYYEC-217-01
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 30, 2024
• Est. completion date: December 31, 2025

Study information

• Verified date: January 2024
• Source: Beijing Hospital
• Contact: Min Li, Ph.D.
• Phone: +8613811526308
• Email: mindy99999[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 300
• Est. completion date: December 31, 2025
• Est. primary completion date: August 31, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 60 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diagnosis
• Disease
• Enuresis
• Pelvic Organ Prolapse
• Prolapse
• Urinary Incontinence

Intervention

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.
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Beijing Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	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