A Study of the Use of Vaginal Radiofrequency Therapy in Treatment of SUI.

Study Overview
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Brief Summary
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To investigate the immediate, short-term and long-term efficacy of vaginal radiofrequency therapy in the treatment of stress urinary incontinence, and to compare the efficacy of pelvic floor electromyography combined with biofeedback therapy in stress urinary incontinence.

Detailed Description
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Before treatment, patients with mild and moderate stress urinary incontinence were diagnosed according to the diagnostic criteria through medical history inquiry and gynecological physical examination, and patients were screened according to the inclusion and exclusion criteria. After informing two treatment plans and signing the informed consent, they were randomly divided into vaginal radiofrequency therapy group and electrical stimulation combined biofeedback group. After being included in the test, one hour urine pad test was conducted, and IIQ-7, PISQ-12 and FSFI questionnaires were completed. IIQ-7, PISQ-12 and FSFI questionnaires were followed up 1, 3, 6 and 12 months after treatment. After 3 months and 1 year of treatment, 1 hour urine pad test was given again.

Official Title
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A Randomized Controlled Clinical Study of the Use of Vaginal Radiofrequency Therapy in Treatment of Stress Urinary Incontinence.

Conditions
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Urinary Incontinence, Stress

Intervention / Treatment
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* Device: physical therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18-75 years old women with a sexual history, and patients with mild to moderate stress urinary incontinence. Exclusion Criteria: Severe cardiopulmonary insufficiency, acute pelvic inflammatory disease or other infectious stage, non-steroidal anti-inflammatory drugs and steroid hormones affecting collagen production factors, POP-Q-2 and above prolapse.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 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: vaginal radiofrequency<br>vaginal radiofrequency therapy 4 times | Device: physical therapy<br>* medical treatment of pelvic floor<br>|
| Active Comparator: electromyography biofeedback<br>electromyography combined with biofeedback therapy 15 times | Device: physical therapy<br>* medical treatment of pelvic floor<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Urine leakage in 1-hour pad test | measure the urine leakage in 1-hour pad test | before therapy | 
| Change from urine leakage at 3 months | measure the urine leakage in 1-hour pad test at 3 months | 3months after therapy | 
| Change from urine leakage at 12 months | measure the urine leakage in 1-hour pad test at 12 months | 12months after therapy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| incontinence impact questionnaire short form,IIQ-7 | Urinary incontinence may affect daily activities, interpersonal relationships or personal emotions.The minimum value is 0,and the maximum value is 21. Higher scores mean a worse outcome. | before therapy | 
| incontinence impact questionnaire short form,IIQ-7 | Urinary incontinence may affect daily activities, interpersonal relationships or personal emotions.The minimum value is 0,and the maximum value is 21. Higher scores mean a worse outcome. | 3months after therapy | 
| incontinence impact questionnaire short form,IIQ-7 | Urinary incontinence may affect daily activities, interpersonal relationships or personal emotions.The minimum value is 0,and the maximum value is 21. Higher scores mean a worse outcome. | 12months after therapy | 
| pelvic organ prolapsed-incontinence sexual questionnaire, PISQ-12 | The sexual desire，orgasm，pain，urine leakage in sex of the participants.The minimum value is 0,and the maximum value is 48.Higher scores mean a better outcome. | before therapy | 
| pelvic organ prolapsed-incontinence sexual questionnaire, PISQ-12 | The sexual desire，orgasm，pain，urine leakage in sex of the participants.The minimum value is 0,and the maximum value is 48.Higher scores mean a better outcome. | 3months after therapy | 
| pelvic organ prolapsed-incontinence sexual questionnaire, PISQ-12 | The sexual desire，orgasm，pain，urine leakage in sex of the participants.The minimum value is 0,and the maximum value is 48.Higher scores mean a better outcome. | 12months after therapy | 
| Female Sexual index，FSFI | Sex frequency，sexual satisfaction, physiological factors, affective factor , sexual partner factor. The minimum value is 0,and the maximum value is 124.Higher scores mean a better outcome. | before therapy | 
| Female Sexual index，FSFI | Sex frequency，sexual satisfaction, physiological factors, affective factor , sexual partner factor. The minimum value is 0,and the maximum value is 124.Higher scores mean a better outcome. | 3months after therapy | 
| Female Sexual index，FSFI | Sex frequency，sexual satisfaction, physiological factors, affective factor , sexual partner factor.The minimum value is 0,and the maximum value is 124. Higher scores mean a better outcome. | 12months after therapy |