Effectiveness and Safety of Electroacupuncture on Poststroke Urinary Incontinence

Kyung Hee University

Status: Completed

Conditions: Stroke, Complication; Urinary Incontinence

Treatments: Device: Electroacupuncture (EA); Device: Sham electroacupuncture

Study type: Interventional

Funder types: Other

Identifiers

NCT02819336

2016006

KOMCIRB-160215-HR-006 (Other Identifier)

Details and patient eligibility

About

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

Enrollment: 56 patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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56 participants in 2 patient groups

Electroacupuncture (EA) group

Experimental group

Description:

1. Electroacupuncture therapy (10 sessions within 21 days) 2. CV2, CV3, CV4, CV6, and bilateral points of SP11, SP6 (8 acupoints in total) 3. 20 minutes duration with middle frequency (30 Hz) of electrical stimulation 4. Conventional treatments (drugs, traditional herbal medications, rehabilitation therapies, or acupuncture therapies without electrostimulation for stroke and urinary incontinence / electroacupuncture therapies other than the acupoints (CV2, CV3, CV4, CV6, SP1 and SP6) for stroke and urinary incontinence) are permitted.

Treatment:

Device: Electroacupuncture (EA)

Park sham (PS) group

Sham Comparator group

Description:

1. Non-penetrating Park sham electroacupuncture treatment (10 sessions within 21 days) 2. CV2, CV3, CV4, CV6, and bilateral points of SP11, SP6 (8 acupoints in total) 3. 20 minutes duration with undelivered electrostimulation of middle frequency (30 Hz) 4. Conventional treatments (drugs, traditional herbal medications, rehabilitation therapies, or acupuncture therapies without electrostimulation for stroke and urinary incontinence / electroacupuncture therapies other than the acupoints (CV2, CV3, CV4, CV6, SP1 and SP6) for stroke and urinary incontinence) are permitted.

Treatment:

Device: Sham electroacupuncture