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

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

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

Study Overview

• Status: Unknown
• Conditions: Female Stress Urinary Incontinence
• Intervention / Treatment: Device: LIPUS-1; Device: LIPUS-2

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.

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310009
      • Recruiting
      • Second Affiliated Hospital, School of Medicine, Zhejiang University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 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. Treated twice a week for 6 weeks.	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.
PLACEBO_COMPARATOR: Control Group; The placebo was treated with an ultrasound therapy device and used in the same manner as the test group.	Device: LIPUS-2; The placebo was treated with an ultrasound therapy device and used in the same manner as the test group.

What is the study measuring?

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

Collaborators and Investigators

• 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

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 1, 2020
• Primary Completion (ANTICIPATED): December 31, 2021
• Study Completion (ANTICIPATED): December 31, 2021

Study Registration Dates

• First Submitted: October 14, 2019
• First Submitted That Met QC Criteria: October 17, 2019
• First Posted (ACTUAL): October 18, 2019

Study Record Updates

• Last Update Posted (ACTUAL): May 12, 2020
• Last Update Submitted That Met QC Criteria: May 9, 2020
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Keywords: Female Stress Urinary Incontinence
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Urologic Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Urination Disorders; Elimination Disorders; Urinary Incontinence; Enuresis; Urinary Incontinence, Stress
• Other Study ID Numbers: 2019-341

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No