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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| vaginal radiofrequency | Experimental | vaginal radiofrequency therapy 4 times |
|
| electromyography biofeedback | Active Comparator | electromyography combined with biofeedback therapy 15 times |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| physical therapy | Device | medical treatment of pelvic floor |
|
| 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 |
| 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 |
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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.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Li Yan | Contact | +860531-89268917 | yanliqy@163.com | |
| Miao Yuan | Contact | +860531-89268917 | qyfckjys@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Li Yan | Shandong First Medical University | Study Director |
| Miao Yuan | Shandong First Medical University | Principal Investigator |
| Fangfang Zhao |
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| ID | Term |
|---|---|
| D014550 | Urinary Incontinence, Stress |
| ID | Term |
|---|---|
| D014549 | Urinary Incontinence |
| D014555 | Urination Disorders |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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| ID | Term |
|---|---|
| D026741 | Physical Therapy Modalities |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
| D012046 | Rehabilitation |
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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 |
| Shandong First Medical University |
| Principal Investigator |
| Guangli Liu | Shandong First Medical University | Principal Investigator |
| Jing Li | Shandong First Medical University | Principal Investigator |
| Min Lu | Shandong First Medical University | Principal Investigator |
| Hongyan Niu | Shandong First Medical University | Principal Investigator |
| Dongyue Wang | Shandong First Medical University | Principal Investigator |
| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D059411 | Lower Urinary Tract Symptoms |
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |