An interventional study of Personalized pelvic floor rehabilitation program generated by the intelligent diagnosis and treatment system. and Standard pelvic floor muscle training(PFMT) program in Pelvic Organ Prolapse, Urinary Incontinence and Diagnosis, sponsored by Beijing Hospital. Recruiting at 1 site in China. Open to female participants aged 60 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-07-03.
Sponsored by Beijing Hospital · Not applicable, Interventional, and Treatment
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.
521 studies on the registry are indexed under Pelvic Organ Prolapse; 80 are open to participants now.
This study's planned enrollment of 300 is above the median of 80 across 336 interventional studies indexed under Pelvic Organ Prolapse.
Browse Pelvic Organ Prolapse studies →Beijing Hospital is the lead sponsor of 51 studies on the registry; 23 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
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
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.
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.
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.
Time frame: 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.
Time frame: Baseline, Month 3, Month 6, Month 12
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.
Time frame: 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.
Time frame: 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).
Time frame: Baseline, Month 3, Month 6, Month 12
Plan to share: Yes — 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.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report
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.
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