NCT05053373

Evaluation of Integrated Optimization Schemes for Female Stress Incontinence

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 358 (actual)
• Sponsor: Shanghai Yueyang Integrated Medicine Hospital · Academic / Other
• Sex: Female
• Age: 40 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The aim of this study is to determine the effectiveness of PFMT added to EA vs PFMT added sham EA for SUI in women.

Detailed description

We will perform a multicenter, randomized, double-blind, sham-controlled, parallel-group clinical trial in four hospitals in China to compare the effectiveness of EA added to PFMT vs sham EA added to PFMT for women with SUI. The participated women with SUI will be recruited from four participating hospitals or through community clinics by advertising. Participated hospitals include: Yueyang Hospital of Integrated Traditional Chinese and Western Medicine Affiliated to Shanghai University of Traditional Chinese Medicine (Shanghai, China); Shaanxi Hospital of Traditional Chinese Medicine (Xi'an, China); First Teaching Hospital of Tianjin University of Traditional Chinese Medicine (Tianjin, China); and Nanjing Hospital of Chinese Medicine Affiliated to Nanjing University of Chinese Medicine (Nanjing, China). Patients will be screened for eligibility. Chief complaint, medical history, and general characteristics (such as age, race, education level, body mass index, manner of child delivery, menopause) will be obtained. Those who met inclusion criteria and are interested in participating in the study will sign an informed consent form and then make another appointment to complete the baseline data collection, including the 72-hr bladder diary, 1-h pad test, International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF) score, the weekly mean number of urine pads used). Participants will then be assigned randomly to either a PFMT (3 sets/day for 8 weeks) + EA (3 times per week for 8 weeks) group or a PFMT + sham EA group. The primary and secondary outcome will be measured from week 2 to 32. The participant-reported severity of UI and subjective self-evaluation of therapeutic effects will be recorded. Written informed consent will be obtained from all participants before they are included in the study. All clinical investigations will be conducted according to the principles of the Declaration of Helsinki.

Conditions

• Stress Urinary Incontinence in Women

Interventions

Type	Name	Description
DEVICE	Electroacupuncture group
DEVICE	Sham electroacupuncture group
BEHAVIORAL	Pelvic floor muscle training

Timeline

• Start date: 2014-05-20
• Primary completion: 2017-06-09
• Completion: 2017-11-21
• First posted: 2021-09-22
• Last updated: 2021-09-22

Locations

4 sites across 1 country: China