Abstract
BackgroundThis study protocol evaluates the effectiveness of adjuvant electroacupuncture (EA) for urinary retention in poststroke patients undergoing conventional treatments, in comparison with that of a sham control.Methods/designA multicenter, blinded, randomized controlled trial will be conducted in three hospitals in the Republic of Korea. We are recruiting 54 stroke survivors (aged >19 years), who were diagnosed with urinary retention based on the results of two consecutive post-void residual (PVR) tests, and dividing them randomly into two arms: the EA and Park-sham control groups.They will receive ten sessions of EA or sham treatment for 2 weeks. The participants will be blinded with non-penetrating needles and fake sounds of EA stimulators. The daily PVR ratio will be primarily measured at baseline and at the end of the study to statistically test the effectiveness of EA for poststroke urinary retention. Then, the Korean version of the Qualiveen Questionnaire, the Korean version of the International Prostate Symptom Score, and the blinding index will be assessed. After each EA session or sham EA, adverse events will be reported to evaluate the safety of EA.Results will be analyzed by using the independent t-test or Mann-Whitney U test, based on both intention-to-treat and per-protocol principles.DiscussionThe findings will provide clinical evidence for the effectiveness of EA treatment to improve urinary retention in stroke survivors.Trial RegistrationThis study protocol was registered in ClinicalTrials.gov (NCT02472288) on 10 June 2015.
Highlights
This study protocol evaluates the effectiveness of adjuvant electroacupuncture (EA) for urinary retention in poststroke patients undergoing conventional treatments, in comparison with that of a sham control
Another randomized controlled trial showed that, besides sham electroacupuncture (EA), EA is an effective treatment of bladder muscle overactivity in poststroke patients [11]
We will conduct a multicenter, randomized controlled trial to evaluate the effectiveness of adjuvant EA therapy for poststroke patients with Urinary retention (UR) who are undergoing conventional treatments, in comparison with that of sham EA
Summary
This randomized controlled trial aims to determine whether EA treatment is effective for UR in poststroke survivors. Because this study is designed to provide clinical evidence for the relevant patients and practitioners, we have chosen not to eliminate any other general treatments for poststroke survivors. Clinical trials of EA for any urinary dysfunction, with a placebo control, are rare, except for the study of poststroke detrusor overactivity [11]. At the end of the project, we expect that the findings will provide clinical evidence of the effectiveness of EA treatment for improving UR in stroke survivors.
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