Urinary RetentionNCT02472288
Electroacupuncture on Post-stroke Urinary Retention
A study testing Electroacupuncture (EA) in people with Urinary Retention and Stroke, Complication, run by Kyunghee University at 3 sites in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Urinary Retention, Stroke, Complication
- What is being tested?
- Electroacupuncture (EA)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 25 participants
- Where
- 3 sitesSouth Korea
- Study dates
- Apr 2015to Apr 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
3 sites in 1 country.
South Korea3 sites
Cheonan Korean Medicine Hospital of the Daejeon University
Cheonan, Chungcheongnam-do, 331-958
Dongguk University Ilsan Oriental Hospital
Goyang-si, Gyeonggi-do, 410-773
Kyung Hee University Korean Medicine Hospital
Seoul, 156-853
About this study
Official title: Multicenter, Randomised Controlled Trial of Electroacupuncture Versus Sham Electroacupuncture for Urinary Retention of Poststroke Patients: a Study Protocol
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.
- Conditions
- Urinary Retention, Stroke, Complication
- Being tested
- Electroacupuncture (EA), Sham electroacupuncture
- Keywords
- urinary retention, poststroke, electroacupuncture, randomized controlled trial, effectiveness, safety
- Medical subject headings
- Urinary Retention, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electroacupuncture (EA)Device
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 electroacupunctureDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Electroacupuncture (EA) group | Experimental | 1. Electroacupuncture therapy (10 sessions in total, 5 per a week, 2 weeks)
2. BL31, BL32, BL33, and BL34 (total 8 acupoints, bilateral)
3. 20 minutes duration, middle frequency (30 Hz) of electrical stimulation
4. conventional treatments permitted Receives: Device: Electroacupuncture (EA) |
| Sham group | Sham comparator | 1. Non-penetrating Park sham electroacupuncture treatment (10 sessions in total, 5 per a week, 2 weeks)
2. BL31, BL32, BL33, and BL34 (total 8 acupoints on the right and left sides)
3. 20 minutes duration, undelivered electrostimulation of middle frequency (30 Hz)
4. conventional treatments permitted Receives: Device: Sham electroacupuncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 0 (baseline), Day 14(endpoint)
Secondary outcomes (6)
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.
Measured: Day 14(endpoint)
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.
Measured: Day 0 (baseline), Day 14(endpoint)
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.
Measured: Day 0 (baseline), Day 14(endpoint)
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.
Measured: Day 14(endpoint)
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
Measured: Day 0 (baseline), Day 14(endpoint)
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
Measured: Every treatment visit (5 times during Day 1~Day 7 & 5 times during Day 8~Day 14)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2015 (estimated)
- Study startApr 2015
- Primary completionApr 2016
- Study completionApr 2016
Why it stopped: Difficulty in enrolling participants
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (20)Papers the sponsor has linked to this study.
- Other trials for Urinary RetentionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kyunghee University
- Sponsor type
- University, hospital or other
- Collaborators
- Daejeon University, DongGuk University
- Responsible party
- Principal investigator, Lee Eui-ju, Kyunghee University
- Investigators
- Euiju Lee, Ph.D., Principal investigator, Kyunghee University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02472288
- Sponsor's protocol ID
- 2015008
- Status last verified
- Aug 2016
- First submitted
- 9 Jun 2015
- Last updated
- 31 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Kong KH, Young S. Incidence and outcome of poststroke urinary retention: a prospective study. Arch Phys Med Rehabil. 2000 Nov;81(11):1464-7. doi: 10.1053/apmr.2000.9630.
PubMed 11083349Wu J, Baguley IJ. Urinary retention in a general rehabilitation unit: prevalence, clinical outcome, and the role of screening. Arch Phys Med Rehabil. 2005 Sep;86(9):1772-7. doi: 10.1016/j.apmr.2005.01.012.
PubMed 16181941Wu P, Mills E, Moher D, Seely D. Acupuncture in poststroke rehabilitation: a systematic review and meta-analysis of randomized trials. Stroke. 2010 Apr;41(4):e171-9. doi: 10.1161/STROKEAHA.109.573576. Epub 2010 Feb 18.
PubMed 20167912Brittain KR, Perry SI, Peet SM, Shaw C, Dallosso H, Assassa RP, Williams K, Jagger C, Potter JF, Castleden CM. Prevalence and impact of urinary symptoms among community-dwelling stroke survivors. Stroke. 2000 Apr;31(4):886-91. doi: 10.1161/01.str.31.4.886.
PubMed 10753993Garrett VE, Scott JA, Costich J, Aubrey DL, Gross J. Bladder emptying assessment in stroke patients. Arch Phys Med Rehabil. 1989 Jan;70(1):41-3.
PubMed 2916918Mizrahi EH, Waitzman A, Arad M, Blumstein T, Adunksy A. Bladder management and the functional outcome of elderly ischemic stroke patients. Arch Gerontol Geriatr. 2011 Sep-Oct;53(2):e125-8. doi: 10.1016/j.archger.2010.07.007. Epub 2010 Aug 12.
PubMed 20708280Mustonen S, Ala-Houhala IO, Tammela TL. Long-term renal dysfunction in patients with acute urinary retention. Scand J Urol Nephrol. 2001 Feb;35(1):44-8. doi: 10.1080/00365590151030804.
PubMed 11291687Curtis LA, Dolan TS, Cespedes RD. Acute urinary retention and urinary incontinence. Emerg Med Clin North Am. 2001 Aug;19(3):591-619. doi: 10.1016/s0733-8627(05)70205-4.
PubMed 11554277Smith MD, Seth JH, Fowler CJ, Miller RF, Panicker JN. Urinary retention for the neurologist. Pract Neurol. 2013 Oct;13(5):288-91. doi: 10.1136/practneurol-2012-000478. Epub 2013 Mar 29.
PubMed 23542501Datta SN, Chaliha C, Singh A, Gonzales G, Mishra VC, Kavia RB, Kitchen N, Fowler CJ, Elneil S. Sacral neurostimulation for urinary retention: 10-year experience from one UK centre. BJU Int. 2008 Jan;101(2):192-6. doi: 10.1111/j.1464-410X.2007.07282.x. Epub 2007 Oct 26.
PubMed 17970787Kessler TM, La Framboise D, Trelle S, Fowler CJ, Kiss G, Pannek J, Schurch B, Sievert KD, Engeler DS. Sacral neuromodulation for neurogenic lower urinary tract dysfunction: systematic review and meta-analysis. Eur Urol. 2010 Dec;58(6):865-74. doi: 10.1016/j.eururo.2010.09.024. Epub 2010 Oct 1.
PubMed 20934242Herr-Wilbert IS, Imhof L, Hund-Georgiadis M, Wilbert DM. Assessment-guided therapy of urinary incontinence after stroke. Rehabil Nurs. 2010 Nov-Dec;35(6):248-53. doi: 10.1002/j.2048-7940.2010.tb00055.x.
PubMed 21140719Tong Y, Jia Q, Sun Y, Hou Z, Wang Y. Acupuncture in the treatment of diabetic bladder dysfunction. J Altern Complement Med. 2009 Aug;15(8):905-9. doi: 10.1089/acm.2009.0062.
PubMed 19678782Yu KW, Lin CL, Hung CC, Chou EC, Hsieh YL, Li TM, Chou LW. Effects of electroacupuncture on recent stroke inpatients with incomplete bladder emptying: a preliminary study. Clin Interv Aging. 2012;7:469-74. doi: 10.2147/CIA.S37531. Epub 2012 Nov 8.
PubMed 23152677Teasdale G, Jennett B. Assessment of coma and impaired consciousness. A practical scale. Lancet. 1974 Jul 13;2(7872):81-4. doi: 10.1016/s0140-6736(74)91639-0. No abstract available.
PubMed 4136544
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter, Randomised Controlled Trial of Electroacupuncture Versus Sham Electroacupuncture for Urinary Retention of Poststroke Patients: a Study Protocol
- ClinicalTrials.gov ID
- NCT02472288
- Acronym / sponsor ID
- 2015008
- Conditions
- Urinary Retention, Stroke, Complication
- Keywords
- urinary retention, poststroke, electroacupuncture, randomized controlled trial, effectiveness, safety
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Difficulty in enrolling participants
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Kyunghee UniversityUniversity, hospital or other
- Collaborators
- Daejeon University, DongGuk University
- Study start
- Apr 2015
- Primary completion
- Apr 2016 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 15 Jun 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Electroacupuncture (EA) group | Experimental | Device: Electroacupuncture (EA)1. Electroacupuncture therapy (10 sessions in total, 5 per a week, 2 weeks) 2. BL31, BL32, BL33, and BL34 (total 8 acupoints, bilateral) 3. 20 minutes duration, middle frequency (30 Hz) of electrical stimulation 4. conventional treatments permitted |
| Sham group | Sham comparator | Device: Sham electroacupuncture1. Non-penetrating Park sham electroacupuncture treatment (10 sessions in total, 5 per a week, 2 weeks) 2. BL31, BL32, BL33, and BL34 (total 8 acupoints on the right and left sides) 3. 20 minutes duration, undelivered electrostimulation of middle frequency (30 Hz) 4. conventional treatments permitted |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Device | Electroacupuncture (EA) group |
| Sham electroacupunctureThe 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. | Device | Sham group |
Primary outcome
Change of daily PVR (Postvoid Residual) urine ratios between the baseline and the endpoint
Time frame: 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.
6 secondary outcomes
Urinary tract infection (UTI)
Time frame: Day 14(endpoint)
Korean version of Qualiveen Questionnaire (K-QQ)
Time frame: Day 0 (baseline), Day 14(endpoint)
Korean version of International Prostate Symptom Scale (K-IPSS)
Time frame: Day 0 (baseline), Day 14(endpoint)
Blinding Index (BI)
Time frame: Day 14(endpoint)
Frequencies of urination and urinary incontinence
Time frame: Day 0 (baseline), Day 14(endpoint)
Adverse events
Time frame: Every treatment visit (5 times during Day 1~Day 7 & 5 times during Day 8~Day 14)
Results and safety
The study was stopped early (reason given: Difficulty in enrolling participants). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2016.
- Background: PubMed 11083349Kong KH, Young S. Incidence and outcome of poststroke urinary retention: a prospective study. Arch Phys Med Rehabil. 2000 Nov;81(11):1464-7. doi: 10.1053/apmr.2000.9630.
- Background: PubMed 16181941Wu J, Baguley IJ. Urinary retention in a general rehabilitation unit: prevalence, clinical outcome, and the role of screening. Arch Phys Med Rehabil. 2005 Sep;86(9):1772-7. doi: 10.1016/j.apmr.2005.01.012.
- Background: PubMed 20167912Wu P, Mills E, Moher D, Seely D. Acupuncture in poststroke rehabilitation: a systematic review and meta-analysis of randomized trials. Stroke. 2010 Apr;41(4):e171-9. doi: 10.1161/STROKEAHA.109.573576. Epub 2010 Feb 18.
- Background: PubMed 10753993Brittain KR, Perry SI, Peet SM, Shaw C, Dallosso H, Assassa RP, Williams K, Jagger C, Potter JF, Castleden CM. Prevalence and impact of urinary symptoms among community-dwelling stroke survivors. Stroke. 2000 Apr;31(4):886-91. doi: 10.1161/01.str.31.4.886.
- Background: PubMed 2916918Garrett VE, Scott JA, Costich J, Aubrey DL, Gross J. Bladder emptying assessment in stroke patients. Arch Phys Med Rehabil. 1989 Jan;70(1):41-3.
- Background: PubMed 20708280Mizrahi EH, Waitzman A, Arad M, Blumstein T, Adunksy A. Bladder management and the functional outcome of elderly ischemic stroke patients. Arch Gerontol Geriatr. 2011 Sep-Oct;53(2):e125-8. doi: 10.1016/j.archger.2010.07.007. Epub 2010 Aug 12.
- Background: PubMed 11291687Mustonen S, Ala-Houhala IO, Tammela TL. Long-term renal dysfunction in patients with acute urinary retention. Scand J Urol Nephrol. 2001 Feb;35(1):44-8. doi: 10.1080/00365590151030804.
- Background: PubMed 11554277Curtis LA, Dolan TS, Cespedes RD. Acute urinary retention and urinary incontinence. Emerg Med Clin North Am. 2001 Aug;19(3):591-619. doi: 10.1016/s0733-8627(05)70205-4.
- Background: PubMed 23542501Smith MD, Seth JH, Fowler CJ, Miller RF, Panicker JN. Urinary retention for the neurologist. Pract Neurol. 2013 Oct;13(5):288-91. doi: 10.1136/practneurol-2012-000478. Epub 2013 Mar 29.
- Background: PubMed 17970787Datta SN, Chaliha C, Singh A, Gonzales G, Mishra VC, Kavia RB, Kitchen N, Fowler CJ, Elneil S. Sacral neurostimulation for urinary retention: 10-year experience from one UK centre. BJU Int. 2008 Jan;101(2):192-6. doi: 10.1111/j.1464-410X.2007.07282.x. Epub 2007 Oct 26.
- Background: PubMed 20934242Kessler TM, La Framboise D, Trelle S, Fowler CJ, Kiss G, Pannek J, Schurch B, Sievert KD, Engeler DS. Sacral neuromodulation for neurogenic lower urinary tract dysfunction: systematic review and meta-analysis. Eur Urol. 2010 Dec;58(6):865-74. doi: 10.1016/j.eururo.2010.09.024. Epub 2010 Oct 1.
- Background: PubMed 21140719Herr-Wilbert IS, Imhof L, Hund-Georgiadis M, Wilbert DM. Assessment-guided therapy of urinary incontinence after stroke. Rehabil Nurs. 2010 Nov-Dec;35(6):248-53. doi: 10.1002/j.2048-7940.2010.tb00055.x.
- The Linguistic Validation and Reliability of the Korean Version 'Qualiveen Questionnaire'. Annals of Rehabilitation Medicine. 2010 Oct;34(5):524-43. (in Korean)Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Euiju Lee, Ph.D. principal investigator
Kyunghee University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Electroacupuncture (EA) in people with Urinary Retention and Stroke, Complication, run by Kyunghee University at 3 sites in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 31 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Difficulty in enrolling participants). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of daily PVR (Postvoid Residual) urine ratios between the baseline and the endpoint (time frame: Day 0 (baseline), Day 14(endpoint)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02472288, which also lists 20 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Aug 2016.