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

Zhejiang University

Status: Unknown

Conditions: Female Stress Urinary Incontinence

Treatments: Device: LIPUS-2; Device: LIPUS-1

Study type: Interventional

Funder types: Other

Identifiers

NCT04131387

2019-341

Details and patient eligibility

About

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

Full 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.

Enrollment: 60 estimated patients

Sex: Female

Ages: 30 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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60 participants in 2 patient groups, including a placebo group

Test Group

Experimental group

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.

Treatment:

Device: LIPUS-1

Control Group

Placebo Comparator group

Description:

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

Treatment:

Device: LIPUS-2