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

NCT04589715 | Unknown

• 1 other identifier: 2019-249-KY-01
• Study Type: interventional
• Target: 160
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Pelvic Organ Prolapse

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

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

  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)

  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）

  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

  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)

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

Study Arms (2)

electroacupuncture group

EXPERIMENTAL

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

sham electroacupuncture group

SHAM COMPARATOR

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

Interventions

electroacupuncture OTHER

the same as described in experimental arm.

electroacupuncture group

sham electroacupuncture OTHER

the same as described in sham comparator.

sham electroacupuncture group

Eligibility Criteria

• Age: 35 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Guang'anmen Hospital of China Academy of Chinese Medical Sciences: lead
• Shaanxi Hospital of Traditional Chinese Medicine: collaborator
• Hunan University of Traditional Chinese Medicine: collaborator
• Lianyungang City Hospital of Traditional Chinese Medicine: collaborator
• Jiangsu Second Hospital of Traditional Chinese Medicine: collaborator
• Shenzhen Second People's Hospital: collaborator

Related Publications (1)

• 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.

  PMID: 35667733 DERIVED

MeSH Terms

Conditions

Pelvic Organ Prolapse

Interventions

Electroacupuncture

Condition Hierarchy (Ancestors)

Prolapse; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Combined Modality Therapy; Therapeutics; Acupuncture Therapy; Complementary Therapies; Electric Stimulation Therapy; Physical Therapy Modalities; Rehabilitation; Transcutaneous Electric Nerve Stimulation; Analgesia; Anesthesia and Analgesia; Anesthesia

Study Officials

• Zhishun Liu, PhD,MD

  Guang'anmen Hospital of China Academy of Chinese Medical Sciences

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Huan Chen, MsPH, MD

CONTACT

+861088002331; chen.huan@live.com

Zhishun Liu, PhD,MD

CONTACT

+861088002331; liuzhishun@aliyun.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Physician, Dean of Acupuncture Department

Model Details: 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.

Study Record Dates

• First Submitted: October 5, 2020
• First Posted: October 19, 2020
• Study Start: October 31, 2020
• Primary Completion: December 31, 2021
• Study Completion: June 30, 2022
• Last Updated: October 19, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share