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

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

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.

Study Overview

• Status: Unknown
• Conditions: Pelvic Organ Prolapse
• Intervention / Treatment: Other: electroacupuncture; Other: 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.

• Study Type: Interventional
• Enrollment (Anticipated): 160
• Phase: Not Applicable

Contacts and Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 35 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: electroacupuncture group; patients will receive electroacupuncture at 3 acupoints(Bladder meridian of foot-taiyang 33 and 35#BL33 and BL35), and Spleen meridian of foot-taiyin 33(SP6)) 3 times/week for 4 weeks, then 3 times/week for 4 weeks, and then once/week for 4 weeks(24 times in total in 3 months), and be followed up for 6 months after treatment. Disposable acupuncture needles with size of 0.30 × 75 mm will be used at BL 33 and BL 35, and needles with size of 0.30 ×40 mm at SP 6. Standardized electroacupuncture apparatuses will be used, and the stimulation will last for 30 minutes with a continuous wave of 20 Hz, and a current intensity of 2 to 6.5 mA at BL33 and BL 35, and 1 to 3.5 mA at SP6.	Other: electroacupuncture; the same as described in experimental arm.
Sham Comparator: sham electroacupuncture group; patient will receive sham electroacupuncture with the same frequency and amount as applied in the electroacupuncture group, as well as the follow-up period. Disposable acupuncture needles with size of 0.30 × 40 mm will be applied and penetrate the skin of patients for 2 to 3mm at sham acupoints to the 3 acupoints mentioned above. The stimulation will only last for 30-second with a very weak currency intensity and a continuous wave of 20 Hz.	Other: sham electroacupuncture; the same as described in sham comparator.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	at baseline, and 3 months when the treatment is completed.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	at baseline, and 3 months when the treatment is completed.
the change from baseline on the score of the Pelvic Floor Impact Questionnaire Short Form-7（PFIQ-7）	Data will be collected via the Pelvic Floor Impact Questionnaire Short Form-7（PFIQ-7) , which uses 7 questions to evaluate the impact of bladder, colorectal and virginal symptoms on daily life, respectively. For each type of symptoms, the answer to one question has four levels, no bother(0), mild bother(1), moderate bother(2), severe bother(3). The higher the total score is, the severer the quality of life is impacted.	at baseline, 3 months, 6 months and 9 months since the start of the treatment.
the change from baseline in the validated Chinese version of International Consultation on Incontinence Questionnaire- Short Form(ICIQ-SF) scores	Data will be collected via International Consultation on Incontinence Questionnaire-Short Form(ICIQ-SF) questionnaire. The total score(0-21scores) is an accumulated scores from question 1 to 3. The higher the total score is, the severer the incontinence is.	at baseline, 3 months, 6 months and 9 months since the start of the treatment.
the change from baseline on the score of pelvic organ prolapse/urinary incontinence sexual questionnaire-12(PISQ-12)	Data will be collected via pelvic organ prolapse/urinary incontinence sexual questionnaire-12(PISQ-12), which uses 10 questions to evaluate the impact of pelvic organ prolapse/urinary incontinence on sexual life for patients. The answer to each question has five levels, including always(4), often(3), sometimes(2), rarely(1), never(0). The higher the total score is, the severer the impact of pelvic organ prolapse/incontinence to sexual life is.	at baseline, 3 months, 6 months and 9 months since the start of the treatment.
score of the patient global index of improvement (PGI-I)	Data will be collected via the Patient Global Index of Improvement (PGI-I) to evaluate the overall treatment effect from patient's perspective. Patient will be asked about their feelings on change of symptoms after treatment. The change can be rated in 7 levels, including major improvement, moderate improvement, mild improvement, no improvement, mild worsening, moderate worsening, and major worsening.	at baseline, 3 months, and 9 months since the start of the treatment.
patients' expectation to the effect of treatment	patients will be asked about their expected effect of the treatment via question: In your expectation, how is your symptoms like in three month. Five choices will be provided 1) much better; 2) slightly better; 3) I don't know; 4)no change; 5) worse.	at baseline, and 3 months when the treatment is completed.
incidence rate of any adverse events	numbers and types of any adverse event associated either with or without acupuncture will be documented as soon as it is reported in any centers. The incidence rate of adverse event will be analyzed and reported.	3 months, 6 months and 9 months since the start of the treatment.
blinding assessment	patients will be asked whether they received electroacupuncture or sham acupuncture to assess the effect of blinding.	in 12th week after any acupuncture treatment

Collaborators and Investigators

• Sponsor: Guang'anmen Hospital of China Academy of Chinese Medical Sciences
• Collaborators: Shenzhen Second People's Hospital; Shaanxi Hospital of Traditional Chinese Medicine; Hunan University of Traditional Chinese Medicine; Lianyungang City Hospital of Traditional Chinese Medicine; Jiangsu Second Hospital of Traditional Chinese Medicine
• Investigators: Principal Investigator: Zhishun Liu, PhD,MD, Guang'anmen Hospital of China Academy of Chinese Medical Sciences

Publications and helpful links

General Publications

• Chen H, Liu X, Yan Y, Shi H, Liu Z. Effect of electroacupuncture on symptoms of female pelvic organ prolapse (stage II-III) (EAPOP study): protocol of a randomised controlled trial. BMJ Open. 2022 Jun 6;12(6):e051249. doi: 10.1136/bmjopen-2021-051249.

Study record dates

Study Major Dates

• Study Start (Anticipated): October 31, 2020
• Primary Completion (Anticipated): December 31, 2021
• Study Completion (Anticipated): June 30, 2022

Study Registration Dates

• First Submitted: October 5, 2020
• First Submitted That Met QC Criteria: October 10, 2020
• First Posted (Actual): October 19, 2020

Study Record Updates

• Last Update Posted (Actual): October 19, 2020
• Last Update Submitted That Met QC Criteria: October 10, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Keywords: Pelvic Organ Prolapse; randomised controlled trial; electroacupuncture; sham acupuncture
• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Prolapse; Pelvic Organ Prolapse
• Other Study ID Numbers: 2019-249-KY-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: We cannot share IPD under current regulation of Human Genetic Resources Management in China.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No