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

Urinary Incontinence, Stress Clinical Trial

Official title:

A Randomized Controlled Clinical Study of the Use of Vaginal Radiofrequency Therapy in Treatment of Stress Urinary Incontinence.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05570071
• Other study ID #: 2022001
• Status: Not yet recruiting
• Phase: N/A
• Start date: October 20, 2022
• Est. completion date: March 31, 2025

Study information

• Verified date: October 2022
• Source: Qianfoshan Hospital
• Contact: Li Yan
• Phone: +860531-89268917
• Email: yanliqy[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 90
• Est. completion date: March 31, 2025
• Est. primary completion date: March 31, 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Enuresis
• Urinary Incontinence
• Urinary Incontinence, Stress

Intervention

Device:
• physical therapy
medical treatment of pelvic floor

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Qianfoshan Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Urine leakage in 1-hour pad test	measure the urine leakage in 1-hour pad test	before therapy
Primary	Change from urine leakage at 3 months	measure the urine leakage in 1-hour pad test at 3 months	3months after therapy
Primary	Change from urine leakage at 12 months	measure the urine leakage in 1-hour pad test at 12 months	12months after therapy
Secondary	incontinence impact questionnaire short form,IIQ-7	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.	before therapy
Secondary	incontinence impact questionnaire short form,IIQ-7	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.	3months after therapy
Secondary	incontinence impact questionnaire short form,IIQ-7	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.	12months after therapy
Secondary	pelvic organ prolapsed-incontinence sexual questionnaire, PISQ-12	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.	before therapy
Secondary	pelvic organ prolapsed-incontinence sexual questionnaire, PISQ-12	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.	3months after therapy
Secondary	pelvic organ prolapsed-incontinence sexual questionnaire, PISQ-12	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.	12months after therapy
Secondary	Female Sexual index,FSFI	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.	before therapy
Secondary	Female Sexual index,FSFI	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.	3months after therapy
Secondary	Female Sexual index,FSFI	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.	12months after therapy