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

Pelvic Organ Prolapse Clinical Trial

— EAPOP  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04589715
• Other study ID #: 2019-249-KY-01
• Status: Not yet recruiting
• Phase: N/A
• Start date: October 31, 2020
• Est. completion date: June 30, 2022

Study information

• Verified date: October 2020
• Source: Guang'anmen Hospital of China Academy of Chinese Medical Sciences
• Contact: Huan Chen, MsPH, MD
• Phone: +861088002331
• Email: chen.huan[@]live.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 160
• Est. completion date: June 30, 2022
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 35 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Pelvic Organ Prolapse
• Prolapse

Intervention

Other:
• electroacupuncture
the same as described in experimental arm.
• sham electroacupuncture
the same as described in sham comparator.

Locations

Country	Name	City	State
n/a

Sponsors (6)

Lead Sponsor	Collaborator
Guang'anmen Hospital of China Academy of Chinese Medical Sciences	Hunan University of Traditional Chinese Medicine, Jiangsu Second Hospital of Traditional Chinese Medicine, Lianyungang City Hospital of Traditional Chinese Medicine, Shaanxi Hospital of Traditional Chinese Medicine, Shenzhen Second People's Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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