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

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Guang'anmen Hospital of China Academy of Chinese Medical Sciences

Status

Unknown

Conditions

Pelvic Organ Prolapse

Treatments

Other: sham electroacupuncture
Other: electroacupuncture

Study type

Interventional

Funder types

Other

Identifiers

NCT04589715
2019-249-KY-01

Details and patient eligibility

About

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.

Full 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.

Enrollment

160 estimated patients

Sex

Female

Ages

35+ years old

Volunteers

No 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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

160 participants in 2 patient groups

electroacupuncture group
Experimental group
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.
Treatment:
Other: electroacupuncture
sham electroacupuncture group
Sham Comparator group
Description:
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.
Treatment:
Other: sham electroacupuncture

Trial contacts and locations

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Central trial contact

Zhishun Liu, PhD,MD; Huan Chen, MsPH, MD

Data sourced from clinicaltrials.gov

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