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 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.