Effect of Electroacupuncture on Symptoms of Female Pelvic Organ Prolapse(Level II - III )
试验速览
- 阶段
- 不适用
- 入组人数
- 160
- 主要终点
- the change from baseline on the score of the Pelvic Floor Distress Inventory-short form 20 (PFDI-20)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 35 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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 >
- •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.
排除标准
- •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.
结局指标
主要结局
the change from baseline on the score of the Pelvic Floor Distress Inventory-short form 20 (PFDI-20)
时间窗: at baseline, and 3 months when the treatment is completed.
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.
次要结局
- 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 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.)
- blinding assessment(in 12th week after any acupuncture treatment)
- 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.)
- patients' expectation to the effect of treatment(at baseline, and 3 months when the treatment is completed.)
- incidence rate of any adverse events(3 months, 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 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.)
- score of the patient global index of improvement (PGI-I)(at baseline, 3 months, and 9 months since the start of the treatment.)
研究者
Liu Zhishun
Chief Physician, Dean of Acupuncture Department
Guang'anmen Hospital of China Academy of Chinese Medical Sciences