Pelvic Organ ProlapseNCT06372340
Intelligent Diagnosis and Treatment System for Pelvic Floor Dysfunction in Elderly Women
A study testing Personalized pelvic floor rehabilitation program generated by the intelligent diagnosis and treatment system. and Standard pelvic floor muscle training(PFMT) program in people with Pelvic Organ Prolapse and Urinary Incontinence, run by Beijing Hospital at 1 site in China.
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… Read more about this study
- Who is it for?
- Ages 60 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pelvic Organ Prolapse, Urinary Incontinence, Diagnosis
- What is being tested?
- Personalized pelvic floor rehabilitation program generated by the intelligent diagnosis and treatment system. and Standard pelvic floor muscle training(PFMT) program
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- 30 Apr 2024to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Women over 60 years old.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Beijing Hospital
Beijing, Beijing Municipality, 100005
Yue Yu, M.D., +8618962068088, joyyu.119@gmail.com
About this study
Official title: 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.
- Conditions
- Pelvic Organ Prolapse, Urinary Incontinence, Diagnosis
- Being tested
- Personalized pelvic floor rehabilitation program generated by the intelligent diagnosis and treatment system., Standard pelvic floor muscle training(PFMT) program
- Keywords
- Urinary incontinence, Pelvic floor muscle, Intelligent diagnosis and treatment system, Elderly female, Pelvic floor dysfunction
- Medical subject headings
- Pelvic Organ Prolapse, Urinary Incontinence, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Personalized pelvic floor rehabilitation program generated by the intelligent diagnosis and treatment system.Procedure or surgery
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) programProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 Receives: Procedure: Standard pelvic floor muscle training(PFMT) program |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Baseline, Month 3, Month 6, Month 12
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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).
Measured: Baseline, Month 3, Month 6, Month 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2024
- Study start30 Apr 2024
- Primary completion31 Aug 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pelvic Organ ProlapseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Mi Li, Ph.D., Study chair, Beijing Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06372340
- Sponsor's protocol ID
- 2023BJYYEC-217-01
- Status last verified
- Jan 2024
- First submitted
- 10 Apr 2024
- Last updated
- 3 Jul 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Development and Application of an Intelligent Diagnosis and Treatment System for Pelvic Floor Dysfunction in Elderly Women
- ClinicalTrials.gov ID
- NCT06372340
- Acronym / sponsor ID
- 2023BJYYEC-217-01
- Conditions
- Pelvic Organ Prolapse, Urinary Incontinence, Diagnosis
- Keywords
- Urinary incontinence, Pelvic floor muscle, Intelligent diagnosis and treatment system, Elderly female, Pelvic floor dysfunction
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Beijing HospitalOther government
- Study start
- 30 Apr 2024 (actual)
- Primary completion
- 31 Aug 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 18 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Supervised and individualized pelvic floor muscle training | Experimental | Procedure: 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. |
| Standard training program | Active comparator | Procedure: Standard pelvic floor muscle training(PFMT) programSubjects in the control group(CG) will accept pelvic floor muscle training according to the handbook or oral guidance |
Who may qualify
- Ages
- 60 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Women over 60 years old.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Procedure or surgery | Supervised and individualized pelvic floor muscle training |
| Standard pelvic floor muscle training(PFMT) programParticipants 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. | Procedure or surgery | Standard training program |
Primary outcome
Modified Oxford Scale (MOS)
Time frame: 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.
Surface Electromyography Data
Time frame: 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.
3 secondary outcomes
The score of Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI SF)
Time frame: Baseline, Month 3, Month 6, Month 12
The score of the Pelvic Floor Distress Inventory (PFDI-20)
Time frame: Baseline, Month 3, Month 6, Month 12
Subjective staging used Pelvic Organ Prolapse Quantification (POP-Q) System
Time frame: Baseline, Month 3, Month 6, Month 12
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2024.
- Individual participant dataSharing planned: 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.
Related trials for Pelvic Organ Prolapse
Active, not recruitingObservational study
Return to Physical Activity After Retropublic Transvaginal Sling and Laparoscopic Sacrocolpopexy
Stress Urinary Incontinence, Pelvic Organ Prolapse
Active, not recruitingObservational study
i-Stitch for Bilateral Sacrospinous Ligament Fixation (SSLF)
Pelvic Organ Prolapse, Genital Prolapse
Recruiting
Safety and Performance of a Pelvic Floor Mesh Implant for Laparoscopic Sacrocolpopexy (ProGYNious)
Pelvic Organ Prolapse (POP), Synthetic Mesh
Recruiting
Pelvic Floor Muscle Training During Pregnancy
Urinary Incontinence, Anal Incontinence
Not yet recruiting
Perineal Protection Device for Reducing Perineal Trauma During Vaginal Delivery in First-time Mothers: a Multicenter Randomized Controlled Trial
Pelvic Floor Dysfunction, Perineal Laceration
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mi Li, Ph.D. study chair
Beijing Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Personalized pelvic floor rehabilitation program generated by the intelligent diagnosis and treatment system. and Standard pelvic floor muscle training(PFMT) program in people with Pelvic Organ Prolapse and Urinary Incontinence, run by Beijing Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Min Li, Ph.D. (+8613811526308, mindy99999@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Modified Oxford Scale (MOS) (time frame: Baseline, Month 3, Month 6, Month 12). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jul 2024; AzTrials last refreshed its copy on 6 Nov 2026.