The Safety and Efficacy of Micro-energy Ultrasound Therapy in the Treatment of Female Stress Urinary Incontinence

Study Overview
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Brief Summary
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The Safety and Efficacy of Micro-energy Ultrasound Therapy in the Treatment of Female Stress Urinary Incontinence: A Multi-center Randomized Trail

Detailed Description
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Study purpose: To evaluate the safety and efficacy of micro-energy ultrasound therapy in the treatment of female stress urinary incontinence Study design: This is a randomized, double-blind, controlled, multi-center clinical trial Study subjects: Females with mild to moderate stress urinary incontinence Number of subjects: 60 Study center: The Second Affiliated Hospital, School of Medicine, Zhejiang University Treatment methods: Test group: After installing the disposable treatment head coat, the pelvic floor muscles, ligaments, etc. were treated with an ultrasonic therapeutic apparatus; after the treatment, the disposable treatment head coat was removed. Patients were treated twice a week for 6 weeks. Control group: The placebo was treated with an ultrasound therapy device and used in the same manner as the test group.

Official Title
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The Safety and Efficacy of Micro-energy Ultrasound Therapy in the Treatment of Female Stress Urinary Incontinence: A Multi-center Randomized Clinical Trial

Conditions
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Female Stress Urinary Incontinence

Intervention / Treatment
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* Device: LIPUS-1
* Device: LIPUS-2


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients diagnosed as mild to moderate female stress urinary incontinence in our hospital; other conservative treatments are ineffective or have poor results, and the operator is not considered for the time being; volunteer to participate in this clinical trial, complied with the requirements of this study and signed the informed consent form. Exclusion Criteria: other types of urinary incontinence; blood routines indicate acute and chronic blood system diseases; B-ultrasound suggests other gynecological diseases; combine uncontrollable diseases such as diabetes, hypertension, and cardiovascular diseases; previous or current history of pelvic surgery and radiotherapy and chemotherapy; the investigator determined that it is not suitable for this clinical trial.

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Test Group<br>After installing the disposable treatment head coat, the pelvic floor muscles, ligaments, etc. were treated with an ultrasonic therapeutic apparatus; after the treatment, the disposable treatment head coat was removed. Treated twice a week for 6 weeks. | Device: LIPUS-1<br>* After installing the disposable treatment head coat, the pelvic floor muscles, ligaments, etc. were treated with an ultrasonic therapeutic apparatus; after the treatment, the disposable treatment head coat was removed. Treated twice a week for 6 weeks.<br>|
| Placebo Comparator: Control Group<br>The placebo was treated with an ultrasound therapy device and used in the same manner as the test group. | Device: LIPUS-2<br>* The placebo was treated with an ultrasound therapy device and used in the same manner as the test group.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The score of ICI-Q-SF | measure the international committee of incontinence brief list of urinary incontinence by a questionnaire | change from baseline level at 2 months after treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Female Stress Urinary Incontinence