A Randomized Controlled Clinical Study of the Use of Vaginal Radiofrequency Therapy in Treatment of Stress Urinary Incontinence.
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Urinary Incontinence, Stress
- Sponsor
- Qianfoshan Hospital
- Enrollment
- 90
- Primary Endpoint
- Urine leakage in 1-hour pad test
- Status
- Not yet recruiting
- Last Updated
- 3 years ago
Overview
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.
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.
Investigators
Li Yan
pfofessor
Qianfoshan Hospital
Eligibility 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.
Outcomes
Primary Outcomes
Urine leakage in 1-hour pad test
Time Frame: before therapy
measure the urine leakage in 1-hour pad test
Change from urine leakage at 3 months
Time Frame: 3months after therapy
measure the urine leakage in 1-hour pad test at 3 months
Change from urine leakage at 12 months
Time Frame: 12months after therapy
measure the urine leakage in 1-hour pad test at 12 months
Secondary Outcomes
- incontinence impact questionnaire short form,IIQ-7(12months after therapy)
- pelvic organ prolapsed-incontinence sexual questionnaire, PISQ-12(12months after therapy)
- Female Sexual index，FSFI(12months after therapy)