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

Second Affiliated Hospital, School of Medicine, Zhejiang University60 enrolled

Overview

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

1. Study purpose: To evaluate the safety and efficacy of micro-energy ultrasound therapy in the treatment of female stress urinary incontinence 2. Study design: This is a randomized, double-blind, controlled, multi-center clinical trial 3. Study subjects: Females with mild to moderate stress urinary incontinence 4. Number of subjects: 60 5. Study center: The Second Affiliated Hospital, School of Medicine, Zhejiang University 6. 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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Female Stress Urinary Incontinence

Interventions

LIPUS-1DEVICE

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.

LIPUS-2DEVICE

The placebo was treated with an ultrasound therapy device and used in the same manner as the test group.

Eligibility

Sex: FEMALEMin age: 30 YearsMax age: 65 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. patients diagnosed as mild to moderate female stress urinary incontinence in our hospital; 2. other conservative treatments are ineffective or have poor results, and the operator is not considered for the time being; 3. volunteer to participate in this clinical trial, complied with the requirements of this study and signed the informed consent form. Exclusion Criteria: 1. other types of urinary incontinence; 2. blood routines indicate acute and chronic blood system diseases; 3. B-ultrasound suggests other gynecological diseases; 4. combine uncontrollable diseases such as diabetes, hypertension, and cardiovascular diseases; 5. previous or current history of pelvic surgery and radiotherapy and chemotherapy; 6. the investigator determined that it is not suitable for this clinical trial.

Locations (1)

Second Affiliated Hospital, School of Medicine, Zhejiang University

Hangzhou, Zhejiang, China

RECRUITING

Outcomes

Primary Outcomes

The score of ICI-Q-SF

measure the international committee of incontinence brief list of urinary incontinence by a questionnaire

Time frame: change from baseline level at 2 months after treatment

Data from ClinicalTrials.gov

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