Abstract
BackgroundUrinary 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.MethodsTwenty 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.DiscussionThis trial will help to identify whether acupuncture is effective for PPI, and, if so, whether it exerts a therapeutic rather than a placebo effect.Trial Registrationwww.Chictr.org.cnChiCTR2100042500. Retrospectively registered on 22 January 2021.
Highlights
Urinary incontinence is a common complication post radical prostatectomy
post-prostatectomy incontinence (PPI) has a significant impact on the quality of life (QoL) of patients who underwent radical prostatectomy
Urinary incontinence after prostate cancer heals within half a year, the need for active improvement of symptoms and the QoL of patients is widely recognized [29]
Summary
Study design This study is a multicenter, single-blind, randomized parallel controlled prospective clinical trial with the objective of estimating the efficacy and safety of acupuncture on PPI by comparing a verum acupuncture group with a sham acupuncture group. Safety assessment To exclude any related serious diseases, patients will be asked to undergo necessary inspection before randomization, including vital signs, blood routine, urine routine, biochemical items, ECG These tests will be performed at the week 6 of the study to evaluate the safety of this trial. Statistical methods Sample size calculation By enrolling approximately 340 (170 in each group) participants, the study will provide 90% power to detect a between-group difference of 2.5 in reduction of ICI-QSF score from baseline using a 2-sided alpha level of 0.05, and assuming a common standard deviation of 6.3 and a dropout rate of 20%. We will use the multiple imputation to handle missing data
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