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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05570071
Other study ID # 2022001
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


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
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