Clinical trial NCT02819336: Effectiveness and Safety of Electroacupuncture on Poststroke Urinary Incontinence
Official title: Effectiveness and Safety of Electroacupuncture on Poststroke Urinary Incontinence: a Pilot Multicentered, Randomized, Parallel, Sham-controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Urinary Incontinence
Stroke, Complication
Keywords: urinary incontinence
electroacupuncture
stroke
complications
randomized controlled trial
pilot projects
Lead sponsor: Kyunghee University
Sponsor class: OTHER
Collaborators: name: Wonkwang University Gwangju Medical Center
First posted: 2016-06-30
Enrollment: 56
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This pilot protocol is aimed to evaluate the effectiveness and safety of electroacupuncture therapy for the post-stroke patients with urinary incontinence.


Eligibility criteria: Inclusion Criteria:

1. Male or female aged over 19 years old
2. Patients diagnosed with stroke (cerebral hemorrhage or infarction) by the examination of computed tomography or magnetic resonance imaging methods within 2 years
3. Twice or more of urination with 3 to 4 points of PPIUS\* at baseline OR 13 points or more of K-IPSS\*
4. Any volunteers who signed the informed consent forms

Exclusion Criteria: We will exclude any patients with

1. Once or more of post-voiding residual \> 200 ml per day
2. Clinically significant stress urinary incontinence diagnosed based on cough induction test or investigator's decision
3. Recurrent urinary tract infection defined as 4 or more treatments for urinary tract infection for the recent 1 year
4. Cognitive impairment with less than 23 points of MMSE-K\* examination
5. Acute or chronic lower urinary tract infection examined by urine culture
6. Urinary incontinence diagnosed before the stroke occurred and the symptoms have continued until now based on medical history
7. Any severe diseases in lower urinary tract based on medical history and screening examination
8. Coagulation disorders based on medical history
9. Peripheral arterial diseases, which resulted in taking medical or surgical procedures to treat them based on medical history
10. Psychiatric diseases based on medical history
11. Fear of acupuncture based on questionnaire test
12. Pregnancy based on urine test
13. Any other inappropriate reasons on which the primary or sub investigators do not let the patients participate in the trial

    * Abbreviations PPIUS; Patient Perception of Intensity of Urgency Scale K-IPSS; The Korean version of International Prostate Symptom Scale MMSE-K; The Korean version of Mini-Mental State Examination

Primary outcomes:
measure: Total Urgency and Frequency Score (TUFS)
timeFrame: at least 15 days (at most 21 days) (at baseline and the end of the treatment)
Secondary outcomes:
measure: International Consultation on Incontinence Questionnaire for Urinary Incontinence Short Form (ICIQ-UI-SF)
timeFrame: at least 15 days (at most 21 days) (at baseline and the end of the treatment)
measure: The Korean version of International Prostate Symptom Scale (K-IPSS)
timeFrame: at least 15 days (at most 21 days) (at baseline and the end of the treatment)
measure: The Lower urinary track system Outcome Score (LOS)
timeFrame: at least 15 days (at most 21 days) (at baseline and the end of the treatment)
measure: Adverse events report
timeFrame: intraoperative
Other outcomes:
measure: Blinding Index (BI)
timeFrame: 21 days
Locations:
city: Gwangju
country: Korea, Republic of
facility: Wonkwang University Gwangju Medical Center
city: Seoul
country: Korea, Republic of
facility: Kyung Hee University Korean Medicine Hospital
Study officials:
affiliation: Kyunghee University
name: Euiju Lee, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
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