Urinary Incontinence, Stress
Conditions
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.
Interventions
DEVICEphysical therapy
medical treatment of pelvic floor
Sponsors
Qianfoshan Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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. |
Contacts
Primary ContactLi Yan
Backup ContactMiao Yuan
Outcome results
None listed