Clinical trial NCT04589715: Effect of Electroacupuncture on Symptoms of Female Pelvic Organ Prolapse(Level II - III)
Official title: Effect of Electroacupuncture on Symptoms of Female Pelvic Organ Prolapse(Level II - III )
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pelvic Organ Prolapse
Keywords: electroacupuncture
sham acupuncture
randomised controlled trial
Pelvic Organ Prolapse
Lead sponsor: Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Sponsor class: OTHER
Collaborators: name: Shaanxi Hospital of Traditional Chinese Medicine
name: Hunan University of Traditional Chinese Medicine
name: Lianyungang City Hospital of Traditional Chinese Medicine
name: Jiangsu Second Hospital of Traditional Chinese Medicine
name: Shenzhen Second People's Hospital
First posted: 2020-10-19
Enrollment: 160
Sex: FEMALE
Minimum age (years): 35
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: the change from baseline on the score of the Pelvic Floor Distress Inventory-short form 20 (PFDI-20)
timeFrame: at baseline, and 3 months when the treatment is completed.
Secondary outcomes:
measure: the change from baseline on the score of the Pelvic Floor Distress Inventory-short form 20 (PFDI-20)
timeFrame: 6 months and 9 months since the start of the treatment.
measure: number of patients at different levels of pelvic organ prolapse quantitative examination(POP-Q)
timeFrame: at baseline, and 3 months when the treatment is completed.
measure: the change from baseline on the score of the Pelvic Floor Impact Questionnaire Short Form-7（PFIQ-7）
timeFrame: at baseline, 3 months, 6 months and 9 months since the start of the treatment.
measure: the change from baseline in the validated Chinese version of International Consultation on Incontinence Questionnaire- Short Form(ICIQ-SF) scores
timeFrame: at baseline, 3 months, 6 months and 9 months since the start of the treatment.
measure: the change from baseline on the score of pelvic organ prolapse/urinary incontinence sexual questionnaire-12(PISQ-12)
timeFrame: at baseline, 3 months, 6 months and 9 months since the start of the treatment.
measure: score of the patient global index of improvement (PGI-I)
timeFrame: at baseline, 3 months, and 9 months since the start of the treatment.
measure: patients' expectation to the effect of treatment
timeFrame: at baseline, and 3 months when the treatment is completed.
measure: incidence rate of any adverse events
timeFrame: 3 months, 6 months and 9 months since the start of the treatment.
measure: blinding assessment
timeFrame: in 12th week after any acupuncture treatment
Other outcomes:
Locations:
Study officials:
affiliation: Guang'anmen Hospital of China Academy of Chinese Medical Sciences
name: Zhishun Liu, PhD,MD
role: PRINCIPAL_INVESTIGATOR
References:
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.