NCT04589715

Effect of Electroacupuncture on Symptoms of Female Pelvic Organ Prolapse(Level II - III)

Effect of Electroacupuncture on Symptoms of Female Pelvic Organ Prolapse(Level II - III )

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 160 (estimated)
• Sponsor: Guang'anmen Hospital of China Academy of Chinese Medical Sciences · Academic / Other
• Sex: Female
• Age: 35 Years
• Healthy volunteers: Not accepted

Summary

The purpose of the study is to assess the efficacy and safety of electroacupuncture among women with pelvic organ prolapse(Level II - III), compared with sham electroacupuncture.

Detailed description

After being informed about the study and potential risk, all patients giving written informed consent form will be undergo a 1-week screening period to determine eligibility for study entry. Eligible patients will be randomly assigned to one of the two groups 1) electroacupuncture group: electroacupuncture will be provided to patients at BL33, BL35 and SP6 for 3 time per week for the first 4 weeks, then twice a week for 4 weeks, and once a week for the last 4 weeks. There will be 24 times of treatment in total in 3 month; 2) sham electroacupuncture group: sham electroacupuncture will be provided to patients at sham acupoints to BL33, BL35 and SP6 with the same schedule as electroacupuncture group.The follow-up time for the two groups are 6 months after treatment. Primary and secondary outcome will be measured at 3, 6, and 9 months from the start of the treatment, respectively.

Conditions

• Pelvic Organ Prolapse

Interventions

Type	Name	Description
OTHER	electroacupuncture	the same as described in experimental arm.
OTHER	sham electroacupuncture	the same as described in sham comparator.

Timeline

• Start date: 2020-10-31
• Primary completion: 2021-12-31
• Completion: 2022-06-30
• First posted: 2020-10-19
• Last updated: 2020-10-19