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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Urinary Incontinence, Stress
• Intervention / Treatment: Device: physical therapy

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 Type: Interventional
• Enrollment (Anticipated): 90
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Li Yan; Phone Number: +860531-89268917; Email: yanliqy@163.com
• Study Contact Backup: Name: Miao Yuan; Phone Number: +860531-89268917; Email: qyfckjys@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: vaginal radiofrequency; vaginal radiofrequency therapy 4 times	Device: physical therapy; medical treatment of pelvic floor
Active Comparator: electromyography biofeedback; electromyography combined with biofeedback therapy 15 times	Device: physical therapy; medical treatment of pelvic floor

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Urine leakage in 1-hour pad test	measure the urine leakage in 1-hour pad test	before therapy
Change from urine leakage at 3 months	measure the urine leakage in 1-hour pad test at 3 months	3months after therapy
Change from urine leakage at 12 months	measure the urine leakage in 1-hour pad test at 12 months	12months after therapy

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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
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
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
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

Collaborators and Investigators

• Sponsor: Qianfoshan Hospital
• Investigators: Study Director: Li Yan, The First Affiliated Hospital Of Shandong First Medical University; Principal Investigator: Miao Yuan, The First Affiliated Hospital Of Shandong First Medical University; Principal Investigator: Fangfang Zhao, The First Affiliated Hospital Of Shandong First Medical University; Principal Investigator: Guangli Liu, The First Affiliated Hospital Of Shandong First Medical University; Principal Investigator: Jing Li, The First Affiliated Hospital Of Shandong First Medical University; Principal Investigator: Min Lu, The First Affiliated Hospital Of Shandong First Medical University; Principal Investigator: Hongyan Niu, The First Affiliated Hospital Of Shandong First Medical University; Principal Investigator: Dongyue Wang, The First Affiliated Hospital Of Shandong First Medical University

Study record dates

Study Major Dates

• Study Start (Anticipated): October 20, 2022
• Primary Completion (Anticipated): March 31, 2025
• Study Completion (Anticipated): March 31, 2025

Study Registration Dates

• First Submitted: September 26, 2022
• First Submitted That Met QC Criteria: October 3, 2022
• First Posted (Actual): October 6, 2022

Study Record Updates

• Last Update Posted (Actual): October 12, 2022
• Last Update Submitted That Met QC Criteria: October 11, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Urologic Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Urination Disorders; Elimination Disorders; Urinary Incontinence; Enuresis; Urinary Incontinence, Stress
• Other Study ID Numbers: 2022001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No