Electroacupuncture on Post-stroke Urinary Retention

Sponsor

Kyunghee University (Other)

Overall Status

Terminated

CT.gov ID

NCT02472288

Collaborator

Daejeon University (Other), DongGuk University (Other)

Enrollment

Locations

Arms

Duration (Months)

8.3

Patients Per Site

0.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study aimed to evaluate the effectiveness of adjuvant electroacupuncture therapy for the post-stroke patients with urinary retention under conventional treatments, compared with sham electroacupuncture.

Condition or Disease	Intervention/Treatment	Phase
Urinary Retention Stroke, Complication	Device: Electroacupuncture (EA) Device: Sham electroacupuncture	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

25 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Multicenter, Randomised Controlled Trial of Electroacupuncture Versus Sham Electroacupuncture for Urinary Retention of Poststroke Patients: a Study Protocol

Study Start Date :

Apr 1, 2015

Actual Primary Completion Date :

Apr 1, 2016

Actual Study Completion Date :

Apr 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Electroacupuncture (EA) group Electroacupuncture therapy (10 sessions in total, 5 per a week, 2 weeks) BL31, BL32, BL33, and BL34 (total 8 acupoints, bilateral) 20 minutes duration, middle frequency (30 Hz) of electrical stimulation conventional treatments permitted	Device: Electroacupuncture (EA) The EA group receives 10 sessions of EA therapy (5 per a week, 2 weeks). After inserting needles by 5-10 mm (stainless steel, 0.25 mm in diameter and 4.0 mm in length, Dong Bang Acupuncture Inc., Korea) using the Park sham guide tube on the 8 points (BL31, BL32, BL33, and BL34, bilateral sides), de qi response is elicited. The electrical stimulation is then presented for 20 minutes by middle frequency (30 Hz) (STN-111, Stratek, Korea). Conventional treatments (western/traditional herbal medications, rehabilitation, or acupuncture without electro-stimulation for stroke, and western/traditional herbal medications or acupuncture without electro-stimulation for urinary retention) are allowed during the intervention period. The practitioner should have over 1-year clinical experiences.
Sham Comparator: Sham group Non-penetrating Park sham electroacupuncture treatment (10 sessions in total, 5 per a week, 2 weeks) BL31, BL32, BL33, and BL34 (total 8 acupoints on the right and left sides) 20 minutes duration, undelivered electrostimulation of middle frequency (30 Hz) conventional treatments permitted	Device: Sham electroacupuncture The patients in sham group receive totally 10 sessions of the sham EA (5 sessions per a week, for 2 weeks). Non-penetrating needles of Park sham device are implemented on the bilateral points of BL31, BL32, BL33, and BL34 (total 8 acupoints). Then, the electro-stimulation is presented for 20 minutes by middle frequency (30 Hz) (STN-111, Stratek, Korea), even though the electrical stimulation is not delivered through the skin. Conventional treatments for stroke and urinary retention along with EAT are not eliminated. It is also necessary for the practitioner with more than 1-year experiences on the clinical field.

Arm

Intervention/Treatment

Experimental: Electroacupuncture (EA) group

Electroacupuncture therapy (10 sessions in total, 5 per a week, 2 weeks) BL31, BL32, BL33, and BL34 (total 8 acupoints, bilateral) 20 minutes duration, middle frequency (30 Hz) of electrical stimulation conventional treatments permitted

Device: Electroacupuncture (EA)

The EA group receives 10 sessions of EA therapy (5 per a week, 2 weeks). After inserting needles by 5-10 mm (stainless steel, 0.25 mm in diameter and 4.0 mm in length, Dong Bang Acupuncture Inc., Korea) using the Park sham guide tube on the 8 points (BL31, BL32, BL33, and BL34, bilateral sides), de qi response is elicited. The electrical stimulation is then presented for 20 minutes by middle frequency (30 Hz) (STN-111, Stratek, Korea). Conventional treatments (western/traditional herbal medications, rehabilitation, or acupuncture without electro-stimulation for stroke, and western/traditional herbal medications or acupuncture without electro-stimulation for urinary retention) are allowed during the intervention period. The practitioner should have over 1-year clinical experiences.

Sham Comparator: Sham group

Non-penetrating Park sham electroacupuncture treatment (10 sessions in total, 5 per a week, 2 weeks) BL31, BL32, BL33, and BL34 (total 8 acupoints on the right and left sides) 20 minutes duration, undelivered electrostimulation of middle frequency (30 Hz) conventional treatments permitted

Device: Sham electroacupuncture

The patients in sham group receive totally 10 sessions of the sham EA (5 sessions per a week, for 2 weeks). Non-penetrating needles of Park sham device are implemented on the bilateral points of BL31, BL32, BL33, and BL34 (total 8 acupoints). Then, the electro-stimulation is presented for 20 minutes by middle frequency (30 Hz) (STN-111, Stratek, Korea), even though the electrical stimulation is not delivered through the skin. Conventional treatments for stroke and urinary retention along with EAT are not eliminated. It is also necessary for the practitioner with more than 1-year experiences on the clinical field.

Outcome Measures

Primary Outcome Measures

Change of daily PVR (Postvoid Residual) urine ratios between the baseline and the endpoint [Day 0 (baseline), Day 14(endpoint)]
daily PVR ratio = daily PVR urine volume / (daily PVR urine volume + self voiding volume) Baseline measurement: daily PVR ratio for 24 hours on the day before the first intervention day Endpoint measurement: daily PVR ratio for 24 hours within 3 days after the last intervention day If more than 7 sessions of EA or sham EA are completed and urinary tract is not infected at the end, then the urine volume is measured on the next day of the last intervention. If more than 7 sessions of EA or sham EA are completed and urinary tract is infected at the end, then the urine volume is measured on the 3rd day of the last intervention after anti-infection treatment is carried out for 48 hours.

Secondary Outcome Measures

Urinary tract infection (UTI) [Day 14(endpoint)]
After 7-10 sessions of the EA or sham EA, patients get urinalysis to figure out whether UTI exists. If a patient has UTI, he/she gets antibiotics for 48 hours. When no UTI is found with reexamination of urinalysis, then daily PVR is going to be assessed and included in the final ITT (Intention To Treat) analysis. Otherwise, the data from the patients will be included only in the PP (Per Protocol) analysis.
Korean version of Qualiveen Questionnaire (K-QQ) [Day 0 (baseline), Day 14(endpoint)]
The disease-specific QoL (quality of life) assessment scale for neurogenic bladder Consisting of 30 items and each item is scored by 0 to 4. (The higher score in K-QQ is, the lower QoL of the patients is.) The reliability and validity of K-QQ has been acquired in the previous studies. If more than 7 sessions of EA or sham EA are completed and urinary tract is not infected at the end, then K-QQ is measured on the next day of the last intervention. If more than 7 sessions of EA or sham EA are completed and urinary tract is infected at the end, then K-QQ is measured on the 3rd day of the last intervention after anti-infection treatment is carried out for 48 hours.
Korean version of International Prostate Symptom Scale (K-IPSS) [Day 0 (baseline), Day 14(endpoint)]
Assessment tool for symptoms in lower urinary tract Consisting of 7 items (0 to 5 scores) If more than 7 sessions of EA or sham EA are completed and urinary tract is not infected at the end, then K-IPSS is measured on the next day of the last intervention. If more than 7 sessions of EA or sham EA treatment are completed and urinary tract is infected at the end, then K-IPSS is measured on the 3rd day of the last intervention after anti-infection treatment is carried out for 48 hours.
Blinding Index (BI) [Day 14(endpoint)]
Assessment of patients' blinding Patients are asked which group you think you belong to during the study, and they selects one of the options, EA group, sham group, or Not knowing.
Frequencies of urination and urinary incontinence [Day 0 (baseline), Day 14(endpoint)]
Record of the frequencies of urination and urinary incontinence by urinary diary 1 day before the first intervention and another day after the last intervention Mean change between post- and pre-treatments in EA group comparing with the sham group
Adverse events [Every treatment visit (5 times during Day 1~Day 7 & 5 times during Day 8~Day 14)]
Ask any adverse events after EA or sham interventions and record them in case report forms Evaluate the severity, seriousness, and relevance to the study

Other Outcome Measures

Diabetes mellitus (DM) and benign prostatic hyperplasia (BPH) [Day 0 (baseline)]
Check of diabetes mellitus (DM) and benign prostatic hyperplasia (BPH) in medical history.

Eligibility Criteria

Criteria

Ages Eligible for Study:

19 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

male or female aged over 19
Patients diagnosed with stroke (cerebral hemorrhage or infarction) based on the CT or MRI examination
Those whose onset is within 2 years
Those who have urinary retention after stroke onset (every PVR result is equal or more than 100ml on the 2 consecutive tests)
Those who signed on the informed consent form

Exclusion Criteria:

Patients who have any bleeding disorders based on medical history hearing
Patients who have ever had any medical procedures or surgeries for peripheral vascular diseases based on medical history hearing
Patients who have any psychiatry disorders based on medical history hearing
Patients who have any severe diseases in lower urinary tract symptom based on medical history hearing
Patients who have any acute or chronic infectious diseases in lower urinary tract symptom based on medical history hearing
Acute stage stroke patients (onset within 1 week) whose Glasgow Coma Scale ≤ 8
Patients who have fear about acupuncture
Patients who have changed medications for urinary retention or relevant symptoms, such as urinary incontinence drugs or diuretics, within 3 days
Female who diagnosed with pregnancy by urinalysis
Those who primary or sub investigators judge not to be suitable for the study

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Cheonan Korean Medicine Hospital of the Daejeon University	Cheonan	Chungcheongnam-do	Korea, Republic of	331-958
2	Dongguk University Ilsan Oriental Hospital	Goyang	Gyeonggi-do	Korea, Republic of	410-773
3	Kyung Hee University Korean Medicine Hospital	Seoul		Korea, Republic of	156-853