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

Primary Purpose

Pelvic Organ Prolapse

Status

Unknown status

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

electroacupuncture

sham electroacupuncture

About this trial

This is an interventional treatment trial for Pelvic Organ Prolapse focused on measuring electroacupuncture, sham acupuncture, randomised controlled trial, Pelvic Organ Prolapse

Eligibility Criteria

35 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

female patients with pelvic organ prolapse at level 2-3 via POP-Q examination;
patients at the age of 35 years or older;
patients who have a sensation of bulging or protrusion from virginal area, with or without urinary, bowel, and sexual disorders;
patients who have a score of PFDI-20 > 24.
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:

Patients who have cognitive disorders and cannot understand the content of questionnaires;
Patients who have severe heart, lung, brain, liver, kidney, hematopoietic system, and immune system diseases, or severe malnutrition;
Patients who have cancer or are at terminal stage of severe diseases;
Patients who need finger assistance for defecation, or have severe prolapse of rectum, sigmoid colon or small intestine;
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;
Patients who are receiving any treatment for other gynecological diseases;
Patients who have symptomatic urinary tract infection with urinary pain and urge, or have residual urine volume ≥ 100ml;
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.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

electroacupuncture group

sham electroacupuncture group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

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.

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.

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.

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.

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.

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.

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.

blinding assessment

patients will be asked whether they received electroacupuncture or sham acupuncture to assess the effect of blinding.

Full Information

NCT ID

NCT04589715

First Posted

October 5, 2020

Last Updated

October 10, 2020

Sponsor

Guang'anmen Hospital of China Academy of Chinese Medical Sciences

Collaborators

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, Shenzhen Second People's Hospital

1. Study Identification

Unique Protocol Identification Number

NCT04589715

Brief Title

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

Acronym

EAPOP

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2020

Overall Recruitment Status

Unknown status

Study Start Date

October 31, 2020 (Anticipated)

Primary Completion Date

December 31, 2021 (Anticipated)

Study Completion Date

June 30, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Guang'anmen Hospital of China Academy of Chinese Medical Sciences

Collaborators

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Pelvic Organ Prolapse

Keywords

electroacupuncture, sham acupuncture, randomised controlled trial, Pelvic Organ Prolapse

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

Patients who sign the informed consent form and are eligible for the study entry at week 0 will be randomized to one of the two groups: electroacupuncture group and sham electroacupuncture group. The two groups will be assessed in a paralleled manner, and patients in both groups will be treated for 24 times in 3 months(3 times weekly for 4 weeks, 2 times weekly for 4 weeks and once every week for 4 weeks) and followed up for 6 months after treatment.

Masking

ParticipantInvestigatorOutcomes Assessor

Masking Description

The participants, investigator and outcome assessor will be masked. The care provider cannot be masked, but will be different person from investigator and outcome assessor.

Allocation

Randomized

Enrollment

160 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

electroacupuncture group

Arm Type

Experimental

Arm Description

Arm Title

sham electroacupuncture group

Arm Type

Sham Comparator

Arm Description

Intervention Type

Other

Intervention Name(s)

electroacupuncture

Intervention Description

the same as described in experimental arm.

Intervention Type

Other

Intervention Name(s)

sham electroacupuncture

Intervention Description

the same as described in sham comparator.

Primary Outcome Measure Information:

Title

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

Description

Time Frame

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

Secondary Outcome Measure Information:

Title

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

Description

Time Frame

6 months and 9 months since the start of the treatment.

Title

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

Description

Time Frame

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

Title

the change from baseline on the score of the Pelvic Floor Impact Questionnaire Short Form-7（PFIQ-7）

Description

Time Frame

at baseline, 3 months, 6 months and 9 months since the start of the treatment.

Title

the change from baseline in the validated Chinese version of International Consultation on Incontinence Questionnaire- Short Form(ICIQ-SF) scores

Description

Time Frame

at baseline, 3 months, 6 months and 9 months since the start of the treatment.

Title

the change from baseline on the score of pelvic organ prolapse/urinary incontinence sexual questionnaire-12(PISQ-12)

Description

Time Frame

at baseline, 3 months, 6 months and 9 months since the start of the treatment.

Title

score of the patient global index of improvement (PGI-I)

Description

Time Frame

at baseline, 3 months, and 9 months since the start of the treatment.

Title

patients' expectation to the effect of treatment

Description

Time Frame

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

Title

incidence rate of any adverse events

Description

Time Frame

3 months, 6 months and 9 months since the start of the treatment.

Title

blinding assessment

Description

patients will be asked whether they received electroacupuncture or sham acupuncture to assess the effect of blinding.

Time Frame

in 12th week after any acupuncture treatment

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

35 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: female patients with pelvic organ prolapse at level 2-3 via POP-Q examination; patients at the age of 35 years or older; patients who have a sensation of bulging or protrusion from virginal area, with or without urinary, bowel, and sexual disorders; patients who have a score of PFDI-20 > 24. 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: Patients who have cognitive disorders and cannot understand the content of questionnaires; Patients who have severe heart, lung, brain, liver, kidney, hematopoietic system, and immune system diseases, or severe malnutrition; Patients who have cancer or are at terminal stage of severe diseases; Patients who need finger assistance for defecation, or have severe prolapse of rectum, sigmoid colon or small intestine; 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; Patients who are receiving any treatment for other gynecological diseases; Patients who have symptomatic urinary tract infection with urinary pain and urge, or have residual urine volume ≥ 100ml; 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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Huan Chen, MsPH, MD

Phone

+861088002331

chen.huan@live.com

First Name & Middle Initial & Last Name or Official Title & Degree

Zhishun Liu, PhD,MD

Phone

+861088002331

liuzhishun@aliyun.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Zhishun Liu, PhD,MD

Organizational Affiliation

Guang'anmen Hospital of China Academy of Chinese Medical Sciences

Official's Role

Principal Investigator

12. IPD Sharing Statement

Plan to Share IPD

IPD Sharing Plan Description

We cannot share IPD under current regulation of Human Genetic Resources Management in China.

Citations:

PubMed Identifier

35667733

Citation

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.

Results Reference

derived

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

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