Effectiveness and Safety of Electroacupuncture on Poststroke Urinary Incontinence: Study Protocol of a Pilot Multicentered, Randomized, Parallel, Sham-Controlled Trial

Table 1

Study schedule with enrollment, interventions, and assessment plan.

Study period

Enrollment

Allocation

Postallocation

Closeout

Visits

V1

V2

V3

V4

V5

V6

V7

V8

V9

V10

V11

V12

V13

Time point

Day (−1)

Day 0

Days 1–18 (±3 days)

Day 18 (±3 days)

Enrollment

Informed consent

X

[Demographic information]

X

[Medical history]

X

[Concomitant medication]

X

[Laboratory test]

X

[Uroflowmetry & bladder scan]

X

[PPIUS]

X

[K-IPSS]

X

[MMSE-K]

X

Eligibility screen

X

Random allocation

X

Interventions

[Treatment: electroacupuncture]

⧫

⧫

⧫

⧫

⧫

⧫

⧫

⧫

⧫

⧫

[Control: sham acupuncture]

⧫

⧫

⧫

⧫

⧫

⧫

⧫

⧫

⧫

⧫

Assessments

[PPIUS/TUFS]

X

X

[ICIQ-UI-SF]

X

X

[K-IPSS]

X

X

[LOS]

X

X

[Blinding Index]

X

[Adverse events]

X

X

X

X

X

X

X

X

X

X

This table has been modified from the example template recommended by SPIRIT guideline [9].
Blood test: PSA (prostate specific antigen) test for male participants. Urine test: urinalysis and urine culture for all participants, HCG (human chorionic gonadotropin) test for fertile female participants
MMSE-K: the Korean version of Mini-Mental State Examination; PPIUS: Patient Perception of Intensity of Urgency Scale; TUFS: Total Urgency and Frequency Score; ICIQ-UI-SF: International Consultation on Incontinence Questionnaire for Urinary Incontinence Short Form; K-IPSS: The Korean version of International Prostate Symptom Scale; LOS: Lower urinary track system Outcome Score.