NCT04131387

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University · Academic / Other
• Sex: Female
• Age: 30 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Female Stress Urinary Incontinence

Interventions

Type	Name	Description
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.
DEVICE	LIPUS-2	The placebo was treated with an ultrasound therapy device and used in the same manner as the test group.

Timeline

• Start date: 2020-01-01
• Primary completion: 2021-12-31
• Completion: 2021-12-31
• First posted: 2019-10-18
• Last updated: 2020-05-12

Locations

1 site across 1 country: China