Female Stress Urinary Incontinence
Conditions
Keywords
Female Stress Urinary Incontinence
Brief summary
The Safety and Efficacy of Micro-energy Ultrasound Therapy in the Treatment of Female Stress Urinary Incontinence: A Multi-center Randomized Trail
Detailed description
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.
Interventions
DEVICELIPUS-1
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.
DEVICELIPUS-2
The placebo was treated with an ultrasound therapy device and used in the same manner as the test group.
Sponsors
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
First Affiliated Hospital of Wenzhou Medical University
Second Affiliated Hospital, School of Medicine, Zhejiang University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
30 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The score of ICI-Q-SF | change from baseline level at 2 months after treatment | measure the international committee of incontinence brief list of urinary incontinence by a questionnaire |
Countries
China
Outcome results
None listed