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

Qianfoshan Hospital

Status: Not yet enrolling

Conditions: Urinary Incontinence, Stress

Treatments: Device: physical therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT05570071

2022001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 90 estimated patients

Sex: Female

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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90 participants in 2 patient groups

vaginal radiofrequency

Experimental group

Description:

vaginal radiofrequency therapy 4 times

Treatment:

Device: physical therapy

electromyography biofeedback

Active Comparator group

Description:

electromyography combined with biofeedback therapy 15 times

Treatment:

Device: physical therapy