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

Guang'anmen Hospital of China Academy of Chinese Medical Sciences160 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

160

Conditions

Pelvic Organ Prolapse

Interventions

electroacupunctureOTHER

the same as described in experimental arm.

sham electroacupunctureOTHER

the same as described in sham comparator.

Eligibility

Sex: FEMALEMin age: 35 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. female patients with pelvic organ prolapse at level 2-3 via POP-Q examination; 2. patients at the age of 35 years or older; 3. patients who have a sensation of bulging or protrusion from virginal area, with or without urinary, bowel, and sexual disorders; 4. patients who have a score of PFDI-20 \> 24. 5. Patients who have signed informed consent form and are willing to participate the study voluntarily. Patients will be included if all above 5 items are met. Exclusion Criteria: 1. Patients who have cognitive disorders and cannot understand the content of questionnaires; 2. Patients who have severe heart, lung, brain, liver, kidney, hematopoietic system, and immune system diseases, or severe malnutrition; 3. Patients who have cancer or are at terminal stage of severe diseases; 4. Patients who need finger assistance for defecation, or have severe prolapse of rectum, sigmoid colon or small intestine; 5. Patients who have received(or are receiving) treatments for pelvic floor disorders , including pelvic organ prolapse, stress urinary incontinence, and etc in the past one month; 6. Patients who are receiving any treatment for other gynecological diseases; 7. Patients who have symptomatic urinary tract infection with urinary pain and urge, or have residual urine volume ≥ 100ml; 8. Patients who have diseases affecting the neurological function of pelvic organ, e.g. spinal cord injury, or peripheral nerve injury caused by surgery at lumbosacral area or pelvic floor . Patients will be excluded if they meet any of the above criteria.

Outcomes

Primary Outcomes

the change from baseline on the score of the Pelvic Floor Distress Inventory-short form 20 (PFDI-20)

Data will be collected via the the Pelvic Floor Distress Inventory-short form 20 (PFDI-20) . The questionnaire consists of three sections, pelvic organ prolapse distress inventory 6 (POPDI-6), colorectal-anal distress inventory 8 (CRADI-8), and urinary distress inventory 6 (UDI-6). Each section has 6-8 questions with 5 answers rated from 0-4 in each, and mean score of each section is the total score of this section divided by number of questions in this session. Then the sum of the mean scores of the three section timing 25 will come to the total score of the questionnaire(0-300). The higher the total score is, the severer the symptoms are.

Time frame: at baseline, and 3 months when the treatment is completed.

Secondary Outcomes

the change from baseline on the score of the Pelvic Floor Distress Inventory-short form 20 (PFDI-20)

Data will be collected via the Pelvic Floor Distress Inventory-short form 20 (PFDI-20) . The questionnaire consists of three sections, pelvic organ prolapse distress inventory 6 (POPDI-6), colorectal-anal distress inventory 8 (CRADI-8), and urinary distress inventory 6 (UDI-6). Each section has 6-8 questions with 5 answers rated from 0-4 in each, and mean score of each section is the total score of this section divided by number of questions in this session. Then the sum of the mean scores of the three section timing 25 will come to the total score of the questionnaire(0-300). The higher the total score is, the severer the symptoms are.

Time frame: 6 months and 9 months since the start of the treatment.

number of patients at different levels of pelvic organ prolapse quantitative examination(POP-Q)

Pelvic organ prolapse quantitative examination(POP-Q) is a manual approach to measure the severity of female pelvic organ prolapse with five level from 0 to 4 . The POP-Q examination will be conducted by experienced gynecologists in each participating center. The higher the level is, the severer the symptoms are.

Time frame: at baseline, and 3 months when the treatment is completed.

Central Contacts

Huan Chen, MsPH, MD

CONTACT

+861088002331 chen.huan@live.com

Zhishun Liu, PhD,MD

CONTACT

+861088002331 liuzhishun@aliyun.com

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.