Abstract
This pilot multicentered, randomized, parallel, sham-controlled trial is intended to evaluate the effectiveness and safety of electroacupuncture therapy for poststroke patients with urinary incontinence. Forty stroke survivors aged >19 years will be recruited in 2 hospitals in the Republic of Korea. Patients who experienced stroke within 2 years and satisfy criteria of urinary frequencies ≥2 with either 3 to 4 points on the Patient Perception of Intensity of Urgency Scale or 13 points or more on the Korean version of the International Prostate Symptom Scale (K-IPSS) will be identified, along with other eligibility criteria. Patients will be randomly allocated to either a treatment or control group to receive 10 sessions of electroacupuncture or sham therapies, respectively. Patients and outcome assessors will be blinded. The primary outcome is the change of Total Urgency and Frequency Score between the baseline and the trial endpoint. The K-IPSS, the International Consultation on Incontinence Questionnaire for Urinary Incontinence Short Form, and the Lower Urinary Tract Symptoms Outcome Score will be evaluated for effectiveness assessment. Adverse events will be reported after every session. The Blinding Index will also be calculated. Data will be statistically analyzed with 0.05 significance levels by 2-sided testing.
Highlights
Urinary incontinence (UI) is defined as involuntary loss of urine [1], with reduced ability either to be aware of bladder signals before leakage or to take notice of eventual leakage or both [2]
Another review implied that acupuncture or acupressure therapies exhibited favorable effects on UI patients with overactive bladder symptoms and suggested that a more qualified randomized controlled trial (RCT) should be implemented [10]
The Consolidated Standards of Reporting Trials (CONSORT) [12], Standards for Reporting Interventions in Clinical Trials of Acupuncture (STRICTA) [13], and Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) 2013 [9] guidelines were followed for development of this trial protocol
Summary
Urinary incontinence (UI) is defined as involuntary loss of urine [1], with reduced ability either to be aware of bladder signals before leakage or to take notice of eventual leakage or both [2]. Recommended treatments for poststroke UI include bladder retraining, timed or prompted voiding, intermittent catheterization, the use of anticholinergic medications, and Evidence-Based Complementary and Alternative Medicine. This table has been modified from the example template recommended by SPIRIT guideline [9]. Stroke survivors who received acupuncture showed lower rates of UI than those who received no treatment or usual care, even though the quality of studies was questionable [8]. Another review implied that acupuncture or acupressure therapies exhibited favorable effects on UI patients with overactive bladder symptoms and suggested that a more qualified randomized controlled trial (RCT) should be implemented [10]. This pilot study is aimed at evaluating the effectiveness and safety of EA therapy for poststroke patients with UI, to explore suitable conditions for a future full-scale RCT
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