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

Female Stress Urinary Incontinence Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04131387
• Other study ID #: 2019-341
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2020
• Est. completion date: December 31, 2021

Study information

• Verified date: October 2019
• Source: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 31, 2021
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 30 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Enuresis
• Female Stress Urinary Incontinence
• Urinary Incontinence
• Urinary Incontinence, Stress

Intervention

Device:
• LIPUS-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.
• LIPUS-2
The placebo was treated with an ultrasound therapy device and used in the same manner as the test group.

Locations

Country	Name	City	State
China	Second Affiliated Hospital, School of Medicine, Zhejiang University	Hangzhou	Zhejiang

Sponsors (3)

Lead Sponsor	Collaborator
Second Affiliated Hospital, School of Medicine, Zhejiang University	First Affiliated Hospital of Wenzhou Medical University, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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