Overactive BladderNCT02568774
Acupuncture on Post-Stroke Overactive Bladder
A study testing Traditional Acupuncture in people with Overactive Bladder, run by The University of Hong Kong at 3 sites in 2 countries.
Trial summary
This study evaluates the effect of acupuncture on post-stroke overactive bladder symptoms. Participants will be put into groups randomly and compared. There are two groups: traditional acupuncture and usual care. The ratio of group allocation is 1:1. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Overactive Bladder
- What is being tested?
- Traditional Acupuncture
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 3 sitesin 2 countries
- Study dates
- Aug 2015to Aug 2018
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Chinese aged 18 or above
- Patient suffering from first ever stroke or recurrent stroke with no urinary symptom in previous episode(s);
- Patient with classic symptoms, i.e. urgency, urinary frequency or urge incontinence and Overactive Bladder Symptom Score (OABSS) score ≥3 and the urgency item rated as at least 2-point;
- Not taking any medication for OAB
- Able to communicate
- No current acupuncture or transcutaneous electrical nerve stimulation treatment
Who cannot join
- Urinary retention with post-void urinary volume > 100ml;
- Current urinary tract infection;
- Preexisting history of OAB or bladder outlet obstruction or underactive bladder;
- Significant cognitive impairment with MMSE < or =19;
- Coexisting Alzheimer's disease, Parkinson's disease, spinal cord disorder or progressive neurological disease such as multiple sclerosis;
- Active skin lesion or open wound over the needle placement areas;
Show all 11Show fewer
- Having valvular heart defects, severe cardiac diseases, or bleeding disorders,
- Being fitted with any implanted electrical device such as pacemaker, defibrillator, or brain stimulation;
- Pregnant;
- Malignancies at the sites of selected acupoints;
- Receiving acupuncture treatment 1 month before baseline.
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
Hong Kong2 sites
Tung Wah Eastern Hospital
Hong Kong
Tung Wah Hospital
Hong Kong
China1 site
Shanghai TCM-INTEGRATED Hospital, Shanghai University of Traditional Chinese Medicine
Shanghai
About this study
Official title: Acupuncture on Post-Stroke Overactive Bladder: A Randomized Controlled Trial
This study evaluates the effect of acupuncture on post-stroke overactive bladder symptoms. Participants will be put into groups randomly and compared. There are two groups: traditional acupuncture and usual care. The ratio of group allocation is 1:1.
Read the detailed description
Current practice in management of OAB is quite limited. Acupuncture, which is a major treatment modality of traditional Chinese medicine, has also claimed to have favourable therapeutic effect on OAB. Previous study found that acupuncture at the BL-33 point was effective for controlling the overactive bladder. Although acupuncture has been shown to be effective in treating OAB, there has been no randomized controlled trial examining the efficacy of acupuncture on patients with post-stroke. Given the high incidence of OAB in post-stroke patients, potentially effective alternative treatments should be investigated.
- Conditions
- Overactive Bladder
- Being tested
- Traditional Acupuncture, Usual Care
- Keywords
- Post-stroke
- Medical subject headings
- Urinary Bladder, Overactive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Traditional AcupunctureOther
Treatment is based on the traditional Chinese medicine theory for treating overactive bladder. Qi-transforming function of bladder is regulated by experienced Chinese medicine practitioner.
Usual CareOther
Patients will receive conventional rehabilitation as usual, including standard physiotherapy, bladder training and general advise of fluid intake.
| Study group | Role | What they receive |
|---|---|---|
| Traditional Acupuncture | Experimental | Acupoints which are empirical for treating OAB in terms of Traditional Chinese medicine theory are used (in the sequence of scalp reproduction area and motor area of the unaffected side, RN3, bilateral BL32, BL33, BL28, BL39). And Ear point urinary bladder, and Ear point uterus will be treated after removal of needles. Needles will be left for 30 minutes and then removed. Subjects will be treated with acupuncture 2 times per week for the first 2 weeks and 1 per week for the 3rd and 4th week. Receives: Other: Traditional Acupuncture |
| Usual Care | Other | Patients will receive conventional rehabilitation as usual, including standard physiotherapy, bladder training and general advise of fluid intake. Receives: Other: Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overactive Bladder Symptom Scale (OABSS)
four item questionnaire quantifies overactive bladder symptoms in a single score
Measured: 1-week posttreatment
Secondary outcomes (3)
Number of incontinent episodes measured by bladder diary
Record the frequency of day and night time voiding and incontinence episodes over 3 day periods
Measured: 1-week posttreatment, 4-week posttreatment
Stroke Specific Quality of Life Scale (SS-QoLS)
12 items questionnaire consists of physical and psychosocial subscales: amount of help required completing a task, trouble experienced performing a task and functioning.
Measured: 1-week posttreatment, 4-week posttreatment
Medication measured by bladder diary
number of patients requested medication for OAB from bladder diary.
Measured: 1-week posttreatment, 4-week posttreatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2015 (estimated)
- Study startAug 2015
- Primary completionAug 2018
- Study completionAug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Overactive BladderStudies of the same condition, open and under way.
- More trials run by The University of Hong KongThe sponsor's other registered studies.
- 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Haiyong Chen, The University of Hong Kong
- Investigators
- Wing Fai Yeung, BCM, PhD, Principal investigator, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02568774
- Sponsor's protocol ID
- AcupPSOAB
- Status last verified
- Oct 2018
- First submitted
- 13 Jun 2015
- Last updated
- 11 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acupuncture on Post-Stroke Overactive Bladder: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02568774
- Acronym / sponsor ID
- AcupPSOAB
- Conditions
- Overactive Bladder
- Keywords
- Post-stroke
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Study start
- Aug 2015
- Primary completion
- Aug 2018 (actual)
- Study completion
- Aug 2018 (actual)
- First posted
- 6 Oct 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 evaluates the effect of acupuncture on post-stroke overactive bladder symptoms. Participants will be put into groups randomly and compared. There are two groups: traditional acupuncture and usual care. The ratio of group allocation is 1:1.
Detailed description
Current practice in management of OAB is quite limited. Acupuncture, which is a major treatment modality of traditional Chinese medicine, has also claimed to have favourable therapeutic effect on OAB. Previous study found that acupuncture at the BL-33 point was effective for controlling the overactive bladder. Although acupuncture has been shown to be effective in treating OAB, there has been no randomized controlled trial examining the efficacy of acupuncture on patients with post-stroke. Given the high incidence of OAB in post-stroke patients, potentially effective alternative treatments should be investigated.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Traditional Acupuncture | Experimental | Other: Traditional AcupunctureAcupoints which are empirical for treating OAB in terms of Traditional Chinese medicine theory are used (in the sequence of scalp reproduction area and motor area of the unaffected side, RN3, bilateral BL32, BL33, BL28, BL39). And Ear point urinary bladder, and Ear point uterus will be treated after removal of needles. Needles will be left for 30 minutes and then removed. Subjects will be treated with acupuncture 2 times per week for the first 2 weeks and 1 per week for the 3rd and 4th week. |
| Usual Care | Other | Other: Usual CarePatients will receive conventional rehabilitation as usual, including standard physiotherapy, bladder training and general advise of fluid intake. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Chinese aged 18 or above
- Patient suffering from first ever stroke or recurrent stroke with no urinary symptom in previous episode(s);
- Patient with classic symptoms, i.e. urgency, urinary frequency or urge incontinence and Overactive Bladder Symptom Score (OABSS) score ≥3 and the urgency item rated as at least 2-point;
- Not taking any medication for OAB
- Able to communicate
Key exclusion criteria (11 listed)
- Urinary retention with post-void urinary volume > 100ml;
- Current urinary tract infection;
- Preexisting history of OAB or bladder outlet obstruction or underactive bladder;
- Significant cognitive impairment with MMSE < or =19;
- Coexisting Alzheimer's disease, Parkinson's disease, spinal cord disorder or progressive neurological disease such as multiple sclerosis;
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 |
|---|---|---|
| Traditional AcupunctureTreatment is based on the traditional Chinese medicine theory for treating overactive bladder. Qi-transforming function of bladder is regulated by experienced Chinese medicine practitioner. | Other | Traditional Acupuncture |
| Usual CarePatients will receive conventional rehabilitation as usual, including standard physiotherapy, bladder training and general advise of fluid intake. | Other | Usual Care |
Primary outcome
Overactive Bladder Symptom Scale (OABSS)
Time frame: 1-week posttreatment
four item questionnaire quantifies overactive bladder symptoms in a single score
3 secondary outcomes
Number of incontinent episodes measured by bladder diary
Time frame: 1-week posttreatment, 4-week posttreatment
Stroke Specific Quality of Life Scale (SS-QoLS)
Time frame: 1-week posttreatment, 4-week posttreatment
Medication measured by bladder diary
Time frame: 1-week posttreatment, 4-week posttreatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Oct 2018.
Related trials for Overactive Bladder
Active, not recruitingObservational study
Overactive Bladder Symptoms and Urinary Incontinence In Women With Rheumatoid Arthritis
Rheumatoid Arthritis, Rheumatoid Arthritis (RA)
RecruitingObservational study
Predictive Value of Inflammatory Biomarkers for Mirabegron Response in Women With Overactive Bladder
Overactive Bladder (OAB)
Active, not recruiting
APPROVE Trial: Evaluating a Prescription Digital Therapeutic for Treatment of OAB in Women
Overactive Bladder (OAB), Urinary Urgency
Recruiting
Ambulatory Long Length URodynamics Evaluation
Urology, Urinary Bladder, Overactive
Not yet recruitingPhase 4
Behavioral and/or Mirabegron to Treat Urinary Symptoms in Parkinson Disease
Overactive Bladder, Parkinson Disease
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.
Wing Fai Yeung, BCM, PhD principal investigator
The University of Hong Kong
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Traditional Acupuncture in people with Overactive Bladder, run by The University of Hong Kong at 3 sites in 2 countries.
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 6 inclusion and 11 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: finished, as of the sponsor's last update on 11 Oct 2018. 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 Hong Kong, China. 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. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Overactive Bladder Symptom Scale (OABSS) (time frame: 1-week posttreatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 Oct 2018.