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Acupuncture on Post-Stroke Overactive Bladder

Primary Purpose

Overactive Bladder

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Traditional Acupuncture
Usual Care
Sponsored by
The University of Hong Kong
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Overactive Bladder focused on measuring Post-stroke

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Shanghai TCM-INTEGRATED Hospital, Shanghai University of Traditional Chinese Medicine
  • Tung Wah Eastern Hospital
  • Tung Wah Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Traditional Acupuncture

Usual Care

Arm Description

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.

Patients will receive conventional rehabilitation as usual, including standard physiotherapy, bladder training and general advise of fluid intake.

Outcomes

Primary Outcome Measures

Overactive Bladder Symptom Scale (OABSS)
four item questionnaire quantifies overactive bladder symptoms in a single score

Secondary Outcome Measures

Number of incontinent episodes measured by bladder diary
Record the frequency of day and night time voiding and incontinence episodes over 3 day periods
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.
Medication measured by bladder diary
number of patients requested medication for OAB from bladder diary.

Full Information

First Posted
June 13, 2015
Last Updated
October 10, 2018
Sponsor
The University of Hong Kong
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1. Study Identification

Unique Protocol Identification Number
NCT02568774
Brief Title
Acupuncture on Post-Stroke Overactive Bladder
Official Title
Acupuncture on Post-Stroke Overactive Bladder: A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
October 2018
Overall Recruitment Status
Completed
Study Start Date
August 2015 (undefined)
Primary Completion Date
August 2018 (Actual)
Study Completion Date
August 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The University of Hong Kong

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overactive Bladder
Keywords
Post-stroke

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Traditional Acupuncture
Arm Type
Experimental
Arm Description
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.
Arm Title
Usual Care
Arm Type
Other
Arm Description
Patients will receive conventional rehabilitation as usual, including standard physiotherapy, bladder training and general advise of fluid intake.
Intervention Type
Other
Intervention Name(s)
Traditional Acupuncture
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Usual Care
Intervention Description
Patients will receive conventional rehabilitation as usual, including standard physiotherapy, bladder training and general advise of fluid intake.
Primary Outcome Measure Information:
Title
Overactive Bladder Symptom Scale (OABSS)
Description
four item questionnaire quantifies overactive bladder symptoms in a single score
Time Frame
1-week posttreatment
Secondary Outcome Measure Information:
Title
Number of incontinent episodes measured by bladder diary
Description
Record the frequency of day and night time voiding and incontinence episodes over 3 day periods
Time Frame
1-week posttreatment, 4-week posttreatment
Title
Stroke Specific Quality of Life Scale (SS-QoLS)
Description
12 items questionnaire consists of physical and psychosocial subscales: amount of help required completing a task, trouble experienced performing a task and functioning.
Time Frame
1-week posttreatment, 4-week posttreatment
Title
Medication measured by bladder diary
Description
number of patients requested medication for OAB from bladder diary.
Time Frame
1-week posttreatment, 4-week posttreatment
Other Pre-specified Outcome Measures:
Title
AE measured by open-ended questions
Description
open-ended questions about the experience of adverse events
Time Frame
first week of treatment, second week of treatment, third week of treatment, 1-week posttreatment, 4-week posttreatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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; 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wing Fai Yeung, BCM, PhD
Organizational Affiliation
The University of Hong Kong
Official's Role
Principal Investigator
Facility Information:
Facility Name
Shanghai TCM-INTEGRATED Hospital, Shanghai University of Traditional Chinese Medicine
City
Shanghai
Country
China
Facility Name
Tung Wah Eastern Hospital
City
Hong Kong
Country
Hong Kong
Facility Name
Tung Wah Hospital
City
Hong Kong
Country
Hong Kong

12. IPD Sharing Statement

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Acupuncture on Post-Stroke Overactive Bladder

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