Urinary incontinence is a common complication post radical prostatectomy. Acupuncture is considered an effective treatment for post-prostatectomy incontinence (PPI), but the evidence is still limited. We propose to evaluate the effectiveness of acupuncture in a rigorously conducted trial.
Twenty hospitals will recruit 340 participants with urinary incontinence after radical prostatectomy in China from April 2021 to April 2022. Participants will be randomly allocated to acupuncture or sham acupuncture with a 1:1 ratio using computerized simple random sampling. The study plan consists of 1-week baseline, 6-week treatment, and 18-week follow-up. Eighteen 30-min sessions of acupuncture or sham acupuncture treatment will be provided between weeks 1 and 6. The primary outcome is the change in the International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI-SF) score at the week 6 from the baseline. Secondary outcomes include the change in volume of urine leakage at weeks 4 and 6 from a baseline measured using the 1-h pad test; 72-h incontinence episode frequency based on a 72-h voiding diary; change in the Expanded prostate cancer Index Composite scale (EPIC-26); change in the Self-Rating Anxiety Scale; weekly consumption of pads; and the severity of urinary incontinence based on a 72-h bladder diary and self-assessment of the therapeutic effect. The safety of acupuncture will also be assessed.
This trial will help to identify whether acupuncture is effective for PPI, and, if so, whether it exerts a therapeutic rather than a placebo effect.
www.Chictr.org.cn ChiCTR2100042500 . Retrospectively registered on 22 January 2021.
Trials. 2022 Jan 04*** epublish ***
Yao Zhang, Shanqi Guo, Chaoran Wang, Xiaodi Liu, Yan Liu, Hongcai Shang, Peiying Yang, Liang Wang, Jingbo Zhai, Xiaojiang Li, Yingjie Jia
First Teaching Hospital of Tianjin University of Traditional Chinese Medicine, Tianjin, China., Key Laboratory of Chinese Internal Medicine of Ministry of Education, Dongzhimen Hospital, Beijing University of Chinese Medicine, Beijing, China., Tianjin Medical University General Hospital, Tianjin, China., Tianjin University of Traditional Chinese Medicine, Tianjin, China., First Teaching Hospital of Tianjin University of Traditional Chinese Medicine, Tianjin, China. ., First Teaching Hospital of Tianjin University of Traditional Chinese Medicine, Tianjin, China. .