Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Acupuncture on Post-Stroke Overactive Bladder

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02568774
Recruitment Status : Completed
First Posted : October 6, 2015
Last Update Posted : October 11, 2018
Sponsor:
Information provided by (Responsible Party):
Dr. Haiyong Chen, The University of Hong Kong

Brief 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.

Condition or disease Intervention/treatment Phase
Overactive Bladder Other: Traditional Acupuncture Other: Usual Care Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 34 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Acupuncture on Post-Stroke Overactive Bladder: A Randomized Controlled Trial
Study Start Date : August 2015
Actual Primary Completion Date : August 2018
Actual Study Completion Date : August 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Traditional Acupuncture
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.
Other: Traditional Acupuncture
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 Care
Patients will receive conventional rehabilitation as usual, including standard physiotherapy, bladder training and general advise of fluid intake.
Other: Usual Care
Patients will receive conventional rehabilitation as usual, including standard physiotherapy, bladder training and general advise of fluid intake.




Primary Outcome Measures :
  1. Overactive Bladder Symptom Scale (OABSS) [ Time Frame: 1-week posttreatment ]
    four item questionnaire quantifies overactive bladder symptoms in a single score


Secondary Outcome Measures :
  1. Number of incontinent episodes measured by bladder diary [ Time Frame: 1-week posttreatment, 4-week posttreatment ]
    Record the frequency of day and night time voiding and incontinence episodes over 3 day periods

  2. Stroke Specific Quality of Life Scale (SS-QoLS) [ Time Frame: 1-week posttreatment, 4-week posttreatment ]
    12 items questionnaire consists of physical and psychosocial subscales: amount of help required completing a task, trouble experienced performing a task and functioning.

  3. Medication measured by bladder diary [ Time Frame: 1-week posttreatment, 4-week posttreatment ]
    number of patients requested medication for OAB from bladder diary.


Other Outcome Measures:
  1. AE measured by open-ended questions [ Time Frame: first week of treatment, second week of treatment, third week of treatment, 1-week posttreatment, 4-week posttreatment ]
    open-ended questions about the experience of adverse events



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Chinese aged 18 or above
  2. Patient suffering from first ever stroke or recurrent stroke with no urinary symptom in previous episode(s);
  3. 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;
  4. Not taking any medication for OAB
  5. Able to communicate
  6. No current acupuncture or transcutaneous electrical nerve stimulation treatment

Exclusion Criteria:

  1. Urinary retention with post-void urinary volume > 100ml;
  2. Current urinary tract infection;
  3. Preexisting history of OAB or bladder outlet obstruction or underactive bladder;
  4. Significant cognitive impairment with MMSE < or =19;
  5. Coexisting Alzheimer's disease, Parkinson's disease, spinal cord disorder or progressive neurological disease such as multiple sclerosis;
  6. Active skin lesion or open wound over the needle placement areas;
  7. Having valvular heart defects, severe cardiac diseases, or bleeding disorders,
  8. Being fitted with any implanted electrical device such as pacemaker, defibrillator, or brain stimulation;
  9. Pregnant;
  10. Malignancies at the sites of selected acupoints;
  11. Receiving acupuncture treatment 1 month before baseline.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02568774


Locations
Layout table for location information
China
Shanghai TCM-INTEGRATED Hospital, Shanghai University of Traditional Chinese Medicine
Shanghai, China
Hong Kong
Tung Wah Eastern Hospital
Hong Kong, Hong Kong
Tung Wah Hospital
Hong Kong, Hong Kong
Sponsors and Collaborators
The University of Hong Kong
Investigators
Layout table for investigator information
Principal Investigator: Wing Fai Yeung, BCM, PhD The University of Hong Kong
Layout table for additonal information
Responsible Party: Dr. Haiyong Chen, Research Assistant Professor, The University of Hong Kong
ClinicalTrials.gov Identifier: NCT02568774    
Other Study ID Numbers: AcupPSOAB
First Posted: October 6, 2015    Key Record Dates
Last Update Posted: October 11, 2018
Last Verified: October 2018
Keywords provided by Dr. Haiyong Chen, The University of Hong Kong:
Post-stroke
Additional relevant MeSH terms:
Layout table for MeSH terms
Urinary Bladder, Overactive
Urinary Bladder Diseases
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations