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Electroacupuncture on Post-stroke Urinary Retention

Primary Purpose

Urinary Retention, Stroke, Complication

Status
Terminated
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Electroacupuncture (EA)
Sham electroacupuncture
Sponsored by
Kyunghee University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Urinary Retention focused on measuring urinary retention, poststroke, electroacupuncture, randomized controlled trial, effectiveness, safety

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Cheonan Korean Medicine Hospital of the Daejeon University
  • Dongguk University Ilsan Oriental Hospital
  • Kyung Hee University Korean Medicine Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Electroacupuncture (EA) group

Sham group

Arm Description

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

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

Outcomes

Primary Outcome Measures

Change of daily PVR (Postvoid Residual) urine ratios between the baseline and the 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)
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)
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)
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)
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
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
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

Full Information

First Posted
June 9, 2015
Last Updated
August 29, 2016
Sponsor
Kyunghee University
Collaborators
Daejeon University, DongGuk University
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1. Study Identification

Unique Protocol Identification Number
NCT02472288
Brief Title
Electroacupuncture on Post-stroke Urinary Retention
Official Title
Multicenter, Randomised Controlled Trial of Electroacupuncture Versus Sham Electroacupuncture for Urinary Retention of Poststroke Patients: a Study Protocol
Study Type
Interventional

2. Study Status

Record Verification Date
August 2016
Overall Recruitment Status
Terminated
Why Stopped
Difficulty in enrolling participants
Study Start Date
April 2015 (undefined)
Primary Completion Date
April 2016 (Actual)
Study Completion Date
April 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kyunghee University
Collaborators
Daejeon University, DongGuk University

4. Oversight

Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urinary Retention, Stroke, Complication
Keywords
urinary retention, poststroke, electroacupuncture, randomized controlled trial, effectiveness, safety

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
25 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Electroacupuncture (EA) group
Arm Type
Experimental
Arm Description
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
Arm Title
Sham group
Arm Type
Sham Comparator
Arm Description
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
Intervention Type
Device
Intervention Name(s)
Electroacupuncture (EA)
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Sham electroacupuncture
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change of daily PVR (Postvoid Residual) urine ratios between the baseline and the endpoint
Description
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.
Time Frame
Day 0 (baseline), Day 14(endpoint)
Secondary Outcome Measure Information:
Title
Urinary tract infection (UTI)
Description
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.
Time Frame
Day 14(endpoint)
Title
Korean version of Qualiveen Questionnaire (K-QQ)
Description
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.
Time Frame
Day 0 (baseline), Day 14(endpoint)
Title
Korean version of International Prostate Symptom Scale (K-IPSS)
Description
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.
Time Frame
Day 0 (baseline), Day 14(endpoint)
Title
Blinding Index (BI)
Description
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.
Time Frame
Day 14(endpoint)
Title
Frequencies of urination and urinary incontinence
Description
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
Time Frame
Day 0 (baseline), Day 14(endpoint)
Title
Adverse events
Description
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
Time Frame
Every treatment visit (5 times during Day 1~Day 7 & 5 times during Day 8~Day 14)
Other Pre-specified Outcome Measures:
Title
Diabetes mellitus (DM) and benign prostatic hyperplasia (BPH)
Description
Check of diabetes mellitus (DM) and benign prostatic hyperplasia (BPH) in medical history.
Time Frame
Day 0 (baseline)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Euiju Lee, Ph.D.
Organizational Affiliation
Kyunghee University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cheonan Korean Medicine Hospital of the Daejeon University
City
Cheonan
State/Province
Chungcheongnam-do
ZIP/Postal Code
331-958
Country
Korea, Republic of
Facility Name
Dongguk University Ilsan Oriental Hospital
City
Goyang
State/Province
Gyeonggi-do
ZIP/Postal Code
410-773
Country
Korea, Republic of
Facility Name
Kyung Hee University Korean Medicine Hospital
City
Seoul
ZIP/Postal Code
156-853
Country
Korea, Republic of

12. IPD Sharing Statement

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Electroacupuncture on Post-stroke Urinary Retention

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