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

NCT04131387 | Unknown

• 1 other identifier: 2019-341
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Female Stress Urinary Incontinence

Keywords

Female Stress Urinary Incontinence

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Test Group

EXPERIMENTAL

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

Control Group

PLACEBO COMPARATOR

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

Device: LIPUS-2

Interventions

LIPUS-1 DEVICE

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.

Test Group

LIPUS-2 DEVICE

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

Control Group

Eligibility Criteria

• Age: 30 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Second Affiliated Hospital, School of Medicine, Zhejiang University: lead
• Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine: collaborator
• First Affiliated Hospital of Wenzhou Medical University: collaborator

Study Sites (1)

Second Affiliated Hospital, School of Medicine, Zhejiang University

Hangzhou, Zhejiang, 310009, China

RECRUITING

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 14, 2019
• First Posted: October 18, 2019
• Study Start: January 1, 2020
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2021
• Last Updated: May 12, 2020

Record last verified: 2019-10

Locations

CN (1)