Back to resultsThe Safety and Efficacy of Micro-energy Ultrasound Therapy in the Treatment of Female Stress Urinary Incontinence
Primary Purpose
Female Stress Urinary Incontinence
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
LIPUS-1
LIPUS-2
Sponsored by
About this trial
This is an interventional treatment trial for Female Stress Urinary Incontinence focused on measuring Female Stress Urinary Incontinence
Eligibility Criteria
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.
Sites / Locations
- Second Affiliated Hospital, School of Medicine, Zhejiang UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Test Group
Control Group
Arm Description
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.
The placebo was treated with an ultrasound therapy device and used in the same manner as the test group.
Outcomes
Primary Outcome Measures
The score of ICI-Q-SF
measure the international committee of incontinence brief list of urinary incontinence by a questionnaire
Secondary Outcome Measures
Full Information
NCT ID
NCT04131387
First Posted
October 14, 2019
Last Updated
May 9, 2020
Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University
Collaborators
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine, First Affiliated Hospital of Wenzhou Medical University
1. Study Identification
Unique Protocol Identification Number
NCT04131387
Brief Title
The Safety and Efficacy of Micro-energy Ultrasound Therapy in the Treatment of Female Stress Urinary Incontinence
Official Title
The Safety and Efficacy of Micro-energy Ultrasound Therapy in the Treatment of Female Stress Urinary Incontinence: A Multi-center Randomized Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
October 2019
Overall Recruitment Status
Unknown status
Study Start Date
January 1, 2020 (Actual)
Primary Completion Date
December 31, 2021 (Anticipated)
Study Completion Date
December 31, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University
Collaborators
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine, First Affiliated Hospital of Wenzhou Medical University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Female Stress Urinary Incontinence
Keywords
Female Stress Urinary Incontinence
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Test Group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control Group
Arm Type
Placebo Comparator
Arm Description
The placebo was treated with an ultrasound therapy device and used in the same manner as the test group.
Intervention Type
Device
Intervention Name(s)
LIPUS-1
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
LIPUS-2
Intervention Description
The placebo was treated with an ultrasound therapy device and used in the same manner as the test group.
Primary Outcome Measure Information:
Title
The score of ICI-Q-SF
Description
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
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Second Affiliated Hospital, School of Medicine, Zhejiang University
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310009
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jiaming Wen, Dr.
Phone
+86-571-87783550
Email
wenjiaming@zju.edu.cn
12. IPD Sharing Statement
Learn more about this trial
The Safety and Efficacy of Micro-energy Ultrasound Therapy in the Treatment of Female Stress Urinary Incontinence
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