Pelvic Organ ProlapseEAPOPNCT04589715
Effect of Electroacupuncture on Symptoms of Female Pelvic Organ Prolapse(Level II - III)
A study testing electroacupuncture in people with Pelvic Organ Prolapse, run by Guang'anmen Hospital of China Academy of Chinese Medical Sciences.
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. Read more about this study
- Who is it for?
- Ages 35 years and older, women only
- Conditions the study is for
- Pelvic Organ Prolapse
- What is being tested?
- electroacupuncture
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 160 participants
- Where
- No sites listed yet
- Study dates
- 31 Oct 2020to 30 Jun 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
Show all 9Show fewer
- 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 locations and contacts
No sites are listed yet.
About this study
Official title: Effect of Electroacupuncture on Symptoms of Female Pelvic Organ Prolapse(Level II - III )
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.
Read the 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.
- Conditions
- Pelvic Organ Prolapse
- Being tested
- electroacupuncture, sham electroacupuncture
- Keywords
- electroacupuncture, sham acupuncture, randomised controlled trial, Pelvic Organ Prolapse
- Medical subject headings
- Pelvic Organ Prolapse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
electroacupunctureOther
the same as described in experimental arm.
sham electroacupunctureOther
the same as described in sham comparator.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: sham electroacupuncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
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.
Measured: 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)
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.
Measured: 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）
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.
Measured: 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
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.
Measured: 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)
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.
Measured: 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)
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.
Measured: at baseline, 3 months, and 9 months since the start of the treatment.
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.
Measured: at baseline, and 3 months when the treatment is completed.
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.
Measured: 3 months, 6 months and 9 months since the start of the treatment.
blinding assessment
patients will be asked whether they received electroacupuncture or sham acupuncture to assess the effect of blinding.
Measured: in 12th week after any acupuncture treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2020
- Study start31 Oct 2020 (estimated)
- Primary completion31 Dec 2021 (estimated)
- Study completion30 Jun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pelvic Organ ProlapseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guang'anmen Hospital of China Academy of Chinese Medical Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- Shaanxi Hospital of Traditional Chinese Medicine, Hunan University of Traditional Chinese Medicine, Lianyungang City Hospital of Traditional Chinese Medicine, Jiangsu Second Hospital of Traditional Chinese Medicine, Shenzhen Second People's Hospital
- Responsible party
- Principal investigator, Liu Zhishun, Guang'anmen Hospital of China Academy of Chinese Medical Sciences
- Investigators
- Zhishun Liu, PhD,MD, Principal investigator, Guang'anmen Hospital of China Academy of Chinese Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04589715
- Sponsor's protocol ID
- 2019-249-KY-01
- Acronym
- EAPOP
- Status last verified
- Oct 2020
- First submitted
- 5 Oct 2020
- Last updated
- 19 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: We cannot share IPD under current regulation of Human Genetic Resources Management in China.
Publications
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.
PubMed 35667733
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Electroacupuncture on Symptoms of Female Pelvic Organ Prolapse(Level II - III )
- ClinicalTrials.gov ID
- NCT04589715
- Acronym / sponsor ID
- EAPOP / 2019-249-KY-01
- Conditions
- Pelvic Organ Prolapse
- Keywords
- electroacupuncture, sham acupuncture, randomised controlled trial, Pelvic Organ Prolapse
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Guang'anmen Hospital of China Academy of Chinese Medical SciencesUniversity, hospital or other
- Collaborators
- Shaanxi Hospital of Traditional Chinese Medicine, Hunan University of Traditional Chinese Medicine, Lianyungang City Hospital of Traditional Chinese Medicine, Jiangsu Second Hospital of Traditional Chinese Medicine, Shenzhen Second People's Hospital
- Study start
- 31 Oct 2020 (estimated)
- Primary completion
- 31 Dec 2021 (estimated)
- Study completion
- 30 Jun 2022 (estimated)
- First posted
- 19 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| electroacupuncture group | Experimental | Other: electroacupuncturepatients 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. |
| sham electroacupuncture group | Sham comparator | Other: sham electroacupuncturepatient 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. |
Who may qualify
- Ages
- 35 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (9 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| electroacupuncturethe same as described in experimental arm. | Other | electroacupuncture group |
| sham electroacupuncturethe same as described in sham comparator. | Other | sham electroacupuncture group |
Primary outcome
the change from baseline on the score of the Pelvic Floor Distress Inventory-short form 20 (PFDI-20)
Time frame: 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.
9 secondary outcomes
the change from baseline on the score of the Pelvic Floor Distress Inventory-short form 20 (PFDI-20)
Time frame: 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)
Time frame: 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）
Time frame: 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
Time frame: 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)
Time frame: 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)
Time frame: at baseline, 3 months, and 9 months since the start of the treatment.
patients' expectation to the effect of treatment
Time frame: at baseline, and 3 months when the treatment is completed.
incidence rate of any adverse events
Time frame: 3 months, 6 months and 9 months since the start of the treatment.
blinding assessment
Time frame: in 12th week after any acupuncture treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2020.
- Derived from this study: PubMed 35667733Chen 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.
- Individual participant dataSharing planned: No. We cannot share IPD under current regulation of Human Genetic Resources Management in China.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zhishun Liu, PhD,MD principal investigator
Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Questions about this trial
What is this clinical trial studying?
A study testing electroacupuncture in people with Pelvic Organ Prolapse, run by Guang'anmen Hospital of China Academy of Chinese Medical Sciences.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Huan Chen, MsPH, MD (+861088002331, chen.huan@live.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the change from baseline on the score of the Pelvic Floor Distress Inventory-short form 20 (PFDI-20) (time frame: at baseline, and 3 months when the treatment is completed.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04589715, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2020.