Electroacupuncture versus sham electroacupuncture for urinary retention in poststroke patients: study protocol for a multicenter, randomized controlled trial

Abstract

Background: 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.

Methods/design: A 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.

Discussion: The findings will provide clinical evidence for the effectiveness of EA treatment to improve urinary retention in stroke survivors.

Trial registration: This study protocol was registered in ClinicalTrials.gov (NCT02472288) on 10 June 2015.

Keywords: Cerebrovascular accident; Electroacupuncture; Randomized Controlled Trial; Stroke; Urinary retention.

Fig. 1

Flowchart of the study process. Fifty-four participants will be randomized and allocated to either the intervention or control group. After conducting ten sessions of verum or sham electroacupuncture for 2 weeks and examining for urinary tract infection (UTI), the daily post-void residual (PVR) ratio, Korean version of Qualiveen Questionnaire score (K-QQ), Korean version of the International Prostate Symptom Score (K-IPSS), and blinding index (BI) will be measured. Adverse events will be investigated right after each session

Fig. 2

The locations of acupoints BL31, BL32, BL33, and BL34. In the sacral region, BL31, BL32, BL33, and BL34 are located in the first, second, third, and fourth posterior sacral foramens, respectively. (World Health Organization Standard Acupuncture Point Locations in the Western Pacific Region)