A Study of the Use of Vaginal Radiofrequency Therapy in Treatment of SUI.
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: vaginal radiofrequency vaginal radiofrequency therapy 4 times |
Device: physical therapy
medical treatment of pelvic floor
|
| Active Comparator: electromyography biofeedback electromyography combined with biofeedback therapy 15 times |
Device: physical therapy
medical treatment of pelvic floor
|
Outcome Measures
Primary Outcome Measures
- Urine leakage in 1-hour pad test [before therapy]
measure the urine leakage in 1-hour pad test
- Change from urine leakage at 3 months [3months after therapy]
measure the urine leakage in 1-hour pad test at 3 months
- Change from urine leakage at 12 months [12months after therapy]
measure the urine leakage in 1-hour pad test at 12 months
Secondary Outcome Measures
- incontinence impact questionnaire short form,IIQ-7 [before therapy]
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.
- incontinence impact questionnaire short form,IIQ-7 [3months after therapy]
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.
- incontinence impact questionnaire short form,IIQ-7 [12months after therapy]
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.
- pelvic organ prolapsed-incontinence sexual questionnaire, PISQ-12 [before therapy]
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.
- pelvic organ prolapsed-incontinence sexual questionnaire, PISQ-12 [3months after therapy]
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.
- pelvic organ prolapsed-incontinence sexual questionnaire, PISQ-12 [12months after therapy]
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.
- Female Sexual index，FSFI [before therapy]
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.
- Female Sexual index，FSFI [3months after therapy]
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.
- Female Sexual index，FSFI [12months after therapy]
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.
Eligibility Criteria
Criteria
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.
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Qianfoshan Hospital
Investigators
- Study Director: Li Yan, The First Affiliated Hospital of Shandong First Medical University
- Principal Investigator: Miao Yuan, The First Affiliated Hospital of Shandong First Medical University
- Principal Investigator: Fangfang Zhao, The First Affiliated Hospital of Shandong First Medical University
- Principal Investigator: Guangli Liu, The First Affiliated Hospital of Shandong First Medical University
- Principal Investigator: Jing Li, The First Affiliated Hospital of Shandong First Medical University
- Principal Investigator: Min Lu, The First Affiliated Hospital of Shandong First Medical University
- Principal Investigator: Hongyan Niu, The First Affiliated Hospital of Shandong First Medical University
- Principal Investigator: Dongyue Wang, The First Affiliated Hospital of Shandong First Medical University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2022001