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Abstract
Introduction Overactive bladder (OAB) affects approximately 500 million people worldwide, with a higher prevalence in women than in men, significantly impacting the quality of life of female patients. Treatment options for OAB are currently limited. Previous research has proposed that electroacupuncture could be a viable treatment for OAB in women, but there is a lack of high-quality clinical evidence. This study aims to evaluate the effectiveness of electroacupuncture as a safe and efficient non-pharmacological treatment for female OAB by comparing it with solifenacin succinate.
Methods and analysis This study is a multicentre, single-blind, double-dummy randomised controlled non-inferiority clinical trial involving 204 eligible female participants with OAB. Participants will be randomly assigned in a 1:1 ratio to either the electroacupuncture group (receiving electroacupuncture and placebo) or the solifenacin succinate group (receiving sham electroacupuncture and solifenacin succinate). Each participant will undergo 12 sessions of electroacupuncture (or sham electroacupuncture) treatment and solifenacin succinate (or placebo) treatment over a 4-week period. The primary outcome measure will be the percentage change in the number of micturition episodes every 24 hours at week 4 compared with baseline. Secondary outcomes will include a percentage reduction in the number of micturition episodes every 24 hours at 2th, 8th and 16th weeks of the trial, Overactive Bladder Symptom Score, number of urinary incontinence and urgency episodes every 24 hours based on a 3-day voiding diary, OAB Questionnaire, Generalised Anxiety Disorder Scale-7, King’s Health Questionnaire and Participant Self-evaluation of Therapeutic Effects. Adverse events will be monitored throughout the study. Efficacy analyses will be conducted on both the intention-to-treat population and the per-protocol set population.
Ethics and dissemination Ethical approval has been obtained from the Medical Ethics Committee of Longhua Hospital Shanghai University of Traditional Chinese Medicine (approval number: 2022LCSY097). Each participant will sign a written informed consent before randomisation. The results of this study will be published in a peer-reviewed journal.
Trial registration number NCT05798403.
- Bladder disorders
- Neuro-urology
- COMPLEMENTARY MEDICINE
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Footnotes
BC and PY are joint first authors.
Contributors BC and PY contributed equally to this article as co-first authors. PY and Y-LC contributed to the conception of the study. The manuscript was drafted by BC and PY. WH, QF and JL are responsible for the electroacupuncture treatment in the trial. JH, SM and STC participated in the trial communication and monitoring. YH, LL and XL are responsible for data collection. All authors participated in the reading, discussion and revision of the manuscript and all approved of the protocol for publication. PY is responsible for the overall content as guarantor.
Funding This work was supported by the Shanghai Shenkang Hospital Development Centre Joint Research Project on Emerging Frontier Technologies (SHDC12022103), the Chinese Medicine Inheritance Ancient Literature and Special Techniques Special Project 2022 (GZY-KJS-2022-038), the Shanghai 3-year Action Plan of Accelerating The Inheritance and Development of TCM—The Construction of TCM Specialty Alliance in East China Region and at The Municipal Level—The TCM Pelvic Floor Disease Rehabilitation Specialty Alliance Project (ZY (2021-2023)-0302), the Shanghai Shenkang Hospital Development Centre Medical Enterprise Integration Innovation Synergy Special Project (SHDC2022CRT003), the Shanghai Shenkang Hospital Development Centre demonstration research ward construction project (SHDC2022CRW006) and Shanghai Famous Old Chinese Medicine Experts Academic Experience Research Studio Construction Project (SHGZS-202232).
Disclaimer The funding body has no role in the study design, data collection, data analysis, interpretation of results, writing of the manuscript, or submission of the report for publication.
Competing interests None declared.
Patient and public involvement Patients and/or the public were not involved in the design, or conduct, or reporting, or dissemination plans of this research.
Provenance and peer review Not commissioned; externally peer reviewed.
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