Effect of electroacupuncture on symptoms of female pelvic organ prolapse (stage II–III) (EAPOP study): protocol of a randomised controlled trial
Introduction Pelvic organ prolapse (POP) is downward descent of pelvic organs, which causes symptoms of the lower genital, urinary and gastrointestinal tracts, and undermines women’s daily activities and quality of life. Although studies indicated that electroacupuncture (EA) may be effective in imp...
Saved in:
| Main Authors: | , , , , |
|---|---|
| Format: | Article |
| Language: | English |
| Published: |
BMJ Publishing Group
2022-06-01
|
| Series: | BMJ Open |
| Online Access: | https://bmjopen.bmj.com/content/12/6/e051249.full |
| Tags: |
Add Tag
No Tags, Be the first to tag this record!
|
| _version_ | 1832575368084586496 |
|---|---|
| author | Yan Yan Zhishun Liu Huan Chen Xiaoxu Liu Hangyu Shi |
| author_facet | Yan Yan Zhishun Liu Huan Chen Xiaoxu Liu Hangyu Shi |
| author_sort | Yan Yan |
| collection | DOAJ |
| description | Introduction Pelvic organ prolapse (POP) is downward descent of pelvic organs, which causes symptoms of the lower genital, urinary and gastrointestinal tracts, and undermines women’s daily activities and quality of life. Although studies indicated that electroacupuncture (EA) may be effective in improving the POP symptoms, evidences were not robust. Therefore, this study aims to conduct a randomised controlled trial (RCT) to evaluate the efficacy and safety of electroacupuncture on relieving symptoms of a POP stage II and III among women.Methods and analysis A two-arm, multicentre, patient-blind RCT will be conducted to compare EA with sham electroacupuncture (SEA) for treating symptoms of POP stage II and III among women in six tertiary hospitals in China. One hundred and sixty eligible women will be assigned with a 1:1 ratio to have received either EA or SEA for 24 times in 12 weeks and followed-up for 24 weeks. The primary outcome will be the change on the total score of the Pelvic Floor Distress Inventory-short form 20 at week 12 from baseline, and will be analysed by t-test or multiple regression model. Intention-to-treat analysis will be performed for all outcomes, and a p value of less than 0.05 (two-sided testing) will be considered as statistical significance.Ethics and dissemination The study protocol has been approved by the Medical Ethical Committee of Guang’ammen Hospital (No. 2019-249-KY-01). Patients will be informed about the details of the study and asked to sign consent form before enrolment. The results of this study are expected to be written and published on peer-reviewed journals.Trial registration number NCT04589715. |
| format | Article |
| id | doaj-art-5d20be83ea3d4924b5bc4c8bf290e1ea |
| institution | Kabale University |
| issn | 2044-6055 |
| language | English |
| publishDate | 2022-06-01 |
| publisher | BMJ Publishing Group |
| record_format | Article |
| series | BMJ Open |
| spelling | doaj-art-5d20be83ea3d4924b5bc4c8bf290e1ea2025-02-01T09:30:09ZengBMJ Publishing GroupBMJ Open2044-60552022-06-0112610.1136/bmjopen-2021-051249Effect of electroacupuncture on symptoms of female pelvic organ prolapse (stage II–III) (EAPOP study): protocol of a randomised controlled trialYan Yan0Zhishun Liu1Huan Chen2Xiaoxu Liu3Hangyu Shi4Department of Pharmacy, Beijing Tsinghua Changgung Hospital, School of Clinical Medicine, Tsinghua University, Beijing, ChinaDepartment of Acupuncture, Guanganmen Hospital, China Academy of Chinese Medical Sciences, Beijing, ChinaDepartment of Acupuncture, Guanganmen Hospital, China Academy of Chinese Medical Sciences, Beijing, ChinaDepartment of Acupuncture, China Academy of Chinese Medical Sciences Guanganmen Hospital, Beijing, ChinaBeijing University of Chinese Medicine, Beijing, ChinaIntroduction Pelvic organ prolapse (POP) is downward descent of pelvic organs, which causes symptoms of the lower genital, urinary and gastrointestinal tracts, and undermines women’s daily activities and quality of life. Although studies indicated that electroacupuncture (EA) may be effective in improving the POP symptoms, evidences were not robust. Therefore, this study aims to conduct a randomised controlled trial (RCT) to evaluate the efficacy and safety of electroacupuncture on relieving symptoms of a POP stage II and III among women.Methods and analysis A two-arm, multicentre, patient-blind RCT will be conducted to compare EA with sham electroacupuncture (SEA) for treating symptoms of POP stage II and III among women in six tertiary hospitals in China. One hundred and sixty eligible women will be assigned with a 1:1 ratio to have received either EA or SEA for 24 times in 12 weeks and followed-up for 24 weeks. The primary outcome will be the change on the total score of the Pelvic Floor Distress Inventory-short form 20 at week 12 from baseline, and will be analysed by t-test or multiple regression model. Intention-to-treat analysis will be performed for all outcomes, and a p value of less than 0.05 (two-sided testing) will be considered as statistical significance.Ethics and dissemination The study protocol has been approved by the Medical Ethical Committee of Guang’ammen Hospital (No. 2019-249-KY-01). Patients will be informed about the details of the study and asked to sign consent form before enrolment. The results of this study are expected to be written and published on peer-reviewed journals.Trial registration number NCT04589715.https://bmjopen.bmj.com/content/12/6/e051249.full |
| spellingShingle | Yan Yan Zhishun Liu Huan Chen Xiaoxu Liu Hangyu Shi Effect of electroacupuncture on symptoms of female pelvic organ prolapse (stage II–III) (EAPOP study): protocol of a randomised controlled trial BMJ Open |
| title | Effect of electroacupuncture on symptoms of female pelvic organ prolapse (stage II–III) (EAPOP study): protocol of a randomised controlled trial |
| title_full | Effect of electroacupuncture on symptoms of female pelvic organ prolapse (stage II–III) (EAPOP study): protocol of a randomised controlled trial |
| title_fullStr | Effect of electroacupuncture on symptoms of female pelvic organ prolapse (stage II–III) (EAPOP study): protocol of a randomised controlled trial |
| title_full_unstemmed | Effect of electroacupuncture on symptoms of female pelvic organ prolapse (stage II–III) (EAPOP study): protocol of a randomised controlled trial |
| title_short | Effect of electroacupuncture on symptoms of female pelvic organ prolapse (stage II–III) (EAPOP study): protocol of a randomised controlled trial |
| title_sort | effect of electroacupuncture on symptoms of female pelvic organ prolapse stage ii iii eapop study protocol of a randomised controlled trial |
| url | https://bmjopen.bmj.com/content/12/6/e051249.full |
| work_keys_str_mv | AT yanyan effectofelectroacupunctureonsymptomsoffemalepelvicorganprolapsestageiiiiieapopstudyprotocolofarandomisedcontrolledtrial AT zhishunliu effectofelectroacupunctureonsymptomsoffemalepelvicorganprolapsestageiiiiieapopstudyprotocolofarandomisedcontrolledtrial AT huanchen effectofelectroacupunctureonsymptomsoffemalepelvicorganprolapsestageiiiiieapopstudyprotocolofarandomisedcontrolledtrial AT xiaoxuliu effectofelectroacupunctureonsymptomsoffemalepelvicorganprolapsestageiiiiieapopstudyprotocolofarandomisedcontrolledtrial AT hangyushi effectofelectroacupunctureonsymptomsoffemalepelvicorganprolapsestageiiiiieapopstudyprotocolofarandomisedcontrolledtrial |