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

Not Applicable

Not yet recruiting

• Conditions: Urinary Incontinence, Stress
• Interventions: Device: physical therapy

• Registration Number: NCT05570071
• Lead Sponsor: Qianfoshan Hospital

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.

Study Timeline

• Study First Submitted: 2022-09-26
• Status Verified: 2022-10
• Study First Submitted QC: 2022-10-03
• Study First Posted: 2022-10-06
• Last Update Submitted: 2022-10-11
• Last Update Posted: 2022-10-12
• Study Start: 2022-10-20
• Primary Completion: 2025-03-31
• Study Completion: 2025-03-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 90

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
vaginal radiofrequency	physical therapy	vaginal radiofrequency therapy 4 times
electromyography biofeedback	physical therapy	electromyography combined with biofeedback therapy 15 times

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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	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	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.