the Effect of a New Type of Pelvic Floor Rehabilitation Device PHENIX U4+ on the Treatment of Urinary Incontinence

Study Overview
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Brief Summary
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Enrolled patients with urinary incontinence in Peking University People's Hospital, Wuhan People's Hospital, Zhongshan People's Hospital, and Jiangsu Maternity and Child Health Hospital in the Department of Gynecology, and collected baseline data. The random number table was used to divide the period into observation group and control group. The observation group was treated with a new type of pelvic floor rehabilitation therapy device PHENIX U4+, and the control group was treated with a traditional pelvic floor electrical stimulation therapy device. Follow-up observations during the treatment period and at the end of the treatment, 3 months and 6 months, the main follow-up content includes 1h pad test, 72-hour urination diary, modified Oxford muscle strength classification diagnosis, urinary incontinence-related questionnaires, new equipment inspections, etc. , Track and compare the treatment effect.

Detailed Description
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Use two pelvic floor treatment devices to treat urinary incontinence, collect relevant questionnaires and pelvic floor muscle strength, and compare the two treatment devices.

Official Title
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Construction of the Early Warning and Prevention System for Urinary Incontinence in the Elderly--the Effect of a New Type of Pelvic Floor Rehabilitation Device PHENIX U4+ on the Treatment of Urinary Incontinence--a Multi-center Randomized Controlled Clinical Study

Conditions
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Urinary Incontinence

Intervention / Treatment
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* Device: PHENIX U4+
* Device: Traditional pelvic floor treatment instrument


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria:1) 18 years old and above; 2) Have a history of sexual life; 3) Plan to live locally for a long time; 4) Mild to moderate pressure, urgency or mixed urinary incontinence; 5) The patient agrees to conduct the study and signs an informed consent form. Exclusion Criteria: Combined pelvic organ prolapse (with extrahymen bulging); Obesity (BMI>28kg/m2, BMI=weight (kg)/height square (m2)); Uncontrolled asthma and chronic obstructive pulmonary disease (COPD); Combined connective tissue disease; Women with unclean lochia during pregnancy, within 6 weeks of postpartum and postpartum Malignant tumors; Combined neurological diseases (patients with epilepsy and dementia); Those with a synchronized pacemaker on their chest (biofeedback can be done).

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PHENIX U4+<br>Electrical stimulation treatment for patients with urinary incontinence using a new type of pelvic floor therapy instrument | Device: PHENIX U4+<br>* The newly developed domestic PHENIX U4+ is relatively small in size. In addition to the smooth muscle stimulation function of the traditional therapy device, its electrical stimulation waveform setting can also stimulate the striated muscle, and adds more than 10 A3 reflex treatment options, which can inhibit Urinary reflex, resulting in symptoms related to urinary incontinence in the patient.<br>|
| Active Comparator: Traditional pelvic floor electrical stimulation therapy instrument<br>Electrical stimulation treatment for patients with urinary incontinence using traditional pelvic floor therapy instrument | Device: Traditional pelvic floor treatment instrument<br>* Traditional pelvic floor treatment instrument commonly used in clinical practice<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The difference in the effective rate of urinary incontinence treatment between the two groups | The effective rate of urinary incontinence treatment is judged by whether it leaks urine or not | Before treatment, immediately after treatment, three months after treatment, and six months after treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Differences in pelvic floor electromyography between the two groups |  | Before treatment, immediately after treatment, three months after treatment, and six months after treatment | 
| Differences in 72-hour urination diary | reflect urination of 72 hours | Before treatment, immediately after treatment, three months after treatment, and six months after treatment | 
| Person coefficient of correlation between results of gynecological examination and new equipment examination |  | Before treatment, immediately after treatment, three months after treatment, and six months after treatment | 
| Differences in questionnaire score： PFDI-20 | Questionnaires reflecting pelvic floor function, lower urinary tract symptoms, and quality of life | Before treatment, immediately after treatment, three months after treatment, and six months after treatment | 
| Differences in questionnaire score： ICI-Q-SF | Questionnaires reflecting lower urinary tract symptoms | Before treatment, immediately after treatment, three months after treatment, and six months after treatment | 
| Differences in questionnaire score： OABSS | Questionnaires reflecting lower urinary tract symptoms | Before treatment, immediately after treatment, three months after treatment, and six months after treatment | 
| Differences in questionnaire score： UDI-6 | Questionnaires reflecting lower urinary tract symptoms, and quality of life | Before treatment, immediately after treatment, three months after treatment, and six months after treatment | 
| Differences in pelvic floor pressure test between the two groups |  | Before treatment, immediately after treatment, three months after treatment, and six months after treatment | 
| Differences in pelvic floor tension test between the two groups |  | Before treatment, immediately after treatment, three months after treatment, and six months after treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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new type of pelvic floor rehabilitation device PHENIX U4+, Traditional pelvic floor electrical stimulation therapy instrument