Establishment of an Artificial Intelligence Multidimensional Early Warning Diagnostic and Prognostic Model of Pelvic Floor Rehabilitation Therapy in the Chinese Population: a Prospective Cohort Study.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 1,360
- 试验地点
- 1
- 主要终点
- pelvic floor electromyography
研究概览
简要总结
The goal of this observational study is to learn about the therapeutic effects of different pelvic floor rehabilitation treatments, including pelvic floor muscle training , pelvic floor biofeedback electrical stimulation, and magnetic stimulation, in a population of Chinese patients with female pelvic floor dysfunction disorders. The study aims to find out the individualised pelvic floor rehabilitation treatment plan suitable for the Chinese population. The main question it aims to answer is:
- Do patients with reduced pelvic floor muscle strength after childbirth, or patients with mild to moderate pelvic organ prolapse and symptomatic pelvic organ prolapse benefit from pelvic floor rehabilitation?
- Is the combination of biofeedback electrical stimulation plus pelvic floor magnetic stimulation superior to single electrical stimulation, magnetic stimulation or pelvic floor muscle training?
- Which pelvic floor rehabilitation therapy is most suitable for Chinese patients with female pelvic floor dysfunction?
- What factors are early predictors of developing female pelvic floor dysfunction? And what factors can predict the prognostic status of patients treated with pelvic floor rehabilitation? Participants in the multicenter will be treated with different rehabilitation therapies, during which the researchers will collect clinical symptoms using the PFDI20 questionnaire, and POP-Q scores, pelvic floor muscle strength, and electromyography results from participants before, at the end of, and 3 months and 1 year after the end of treatment.
详细描述
This multicentre, prospective cohort study will be conducted at seven hospital-based pelvic floor health centres nationwide in China. Patients with pelvic floor dysfunctional disorders who are scheduled to undergo pelvic floor rehabilitation are included, including 1) postpartum pelvic floor muscle weakness, 2) mild-to-moderate pelvic organ prolapse (POP), and 3) POP in combination with dysfunction (bowel or bladder dysfunction) or POP in combination with lower urinary tract symptoms (overactive bladder syndrome, constipation, faecal incontinence).
Pelvic floor rehabilitation was performed in accordance with the clinical pathway based on patients' disease characteristics and individual conditions, during which baseline data were collected from patients who met the inclusion and exclusion criteria, as well as follow-up surveys at the end of the treatment, 3 months after the end of the treatment, and 12 months after the end of the treatment. The clinical data collected were used to determine the effectiveness of treatment and to summarise the effects of different rehabilitation programmes on the prognosis of postpartum and middle-aged and elderly PFD patients. The data were matched and compared with the patients' clinical symptoms, signs and auxiliary examinations, so as to optimise and determine the individualised and precise pelvic floor rehabilitation treatment plan.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •knowledge of the study, voluntary enrolment in the study, and signing of informed consent;
- •postpartum pelvic floor weakness (pelvic floor muscle strength less than grade 3), or mild to moderate pelvic organ prolapse (POP-Q staging less than stage III), or pelvic organ prolapse combined with dysfunction (bowel or bladder dysfunction).
排除标准
- •history of comorbid serious medical or surgical illness;
- •comorbid psychiatric disorders;
- •contraindications to electrical and magnetic stimulation such as implanted pacemakers;
- •pelvic malignancy, acute genitourinary infection or vaginal bleeding, and genital tract malformation.
研究组 & 干预措施
pelvic floor muscle training (PFMT)
Control group
干预措施: Pelvic floor muscle training (Behavioral)
pelvic floor biofeedback electrical stimulation
Observation Group 1
干预措施: Biofeedback electrical stimulation (Other)
pelvic floor magnetic stimulation
Observation Group 2
干预措施: Magnetic Stimulation (Other)
Magnetic stimulation combined with biofeedback electrical stimulation
Observation Group 3
干预措施: Magnetic stimulation combined with biofeedback electrical stimulation (Other)
结局指标
主要结局
pelvic floor electromyography
时间窗: Baseline, 0 month and 3 months after pelvic floor rehabilitation.
Pelvic floor electromyography is assessed by the pelvic floor surface electromyography analysis and biofeedback training system. EMG values and parameters regarding muscle contraction and relaxation will be recorded.
pelvic floor muscle strength
时间窗: Baseline, 0 month and 3 months after pelvic floor rehabilitation treatment
Pelvic floor muscle strength was assessed with reference to the Modified Oxford Muscle Strength Classification Method. Pelvic floor muscle strength was graded on a scale of 0-5: 0 for no contraction; 1 for tremor; 2 for slight contraction, with increased muscle strength but no lifting sensation; 3 for moderate contraction, with a sense of lifting of the posterior vaginal wall; 4 for good contraction, with a sense of lifting of the posterior vaginal wall against resistance; and 5 for strong contraction, with a sense of strong wrapping. The higher the grade, the better the pelvic floor strength.
次要结局
- POP-Q(Baseline, 0 month and 3 months after pelvic floor rehabilitation.)
- PFDI-20(Baseline, , 0 month, 3 months and 1 year after pelvic floor rehabilitation.)
研究者
Mingfu Wu
Professor
Tongji Hospital