Effectiveness and Safety of Electroacupuncture on Poststroke Urinary Incontinence

Not Applicable

Completed

• Conditions: Urinary Incontinence; Stroke, Complication
• Interventions: Device: Sham electroacupuncture; Device: Electroacupuncture (EA)

• Registration Number: NCT02819336
• Lead Sponsor: Kyunghee University

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2016-06
• Study First Submitted: 2016-06-28
• Study First Submitted QC: 2016-06-29
• Study First Posted: 2016-06-30
• Primary Completion: 2017-04
• Status Verified: 2017-06
• Study Completion: 2017-06-01
• Last Update Submitted: 2017-06-25
• Last Update Posted: 2017-06-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 56

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Park sham (PS) group	Sham electroacupuncture	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.
Electroacupuncture (EA) group	Electroacupuncture (EA)	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.

Primary Outcome Measures

Name	Time	Method
Total Urgency and Frequency Score (TUFS)	at least 15 days (at most 21 days) (at baseline and the end of the treatment)	The patients will be asked to fill the scale about their perception of urgency intensity (24 hours before the 1st session and after the last session, respectively) by themselves. They have to record every time of urination and select one of the 5 levels in perception of urgency intensity (0=No urgency, 1=Mild urgency, 2=Moderate urgency, 3=Severe urgency, 4= urgency incontinence) for 24 hours at baseline and the end of the treatment, respectively.

Secondary Outcome Measures

Name	Time	Method
International Consultation on Incontinence Questionnaire for Urinary Incontinence Short Form (ICIQ-UI-SF)	at least 15 days (at most 21 days) (at baseline and the end of the treatment)
The Korean version of International Prostate Symptom Scale (K-IPSS)	at least 15 days (at most 21 days) (at baseline and the end of the treatment)
The Lower urinary track system Outcome Score (LOS)	at least 15 days (at most 21 days) (at baseline and the end of the treatment)
Adverse events report	intraoperative

Trial Locations

Locations (2)

Wonkwang University Gwangju Medical Center; 🇰🇷 Gwangju, Korea, Republic of

Kyung Hee University Korean Medicine Hospital; 🇰🇷 Seoul, Korea, Republic of