Acupuncture on Post-Stroke Overactive Bladder

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.

Study Overview

• Status: Completed
• Conditions: Overactive Bladder
• Intervention / Treatment: Other: Traditional Acupuncture; Other: Usual Care

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 Type: Interventional
• Enrollment (Actual): 34
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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.
Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overactive Bladder Symptom Scale (OABSS)	four item questionnaire quantifies overactive bladder symptoms in a single score	1-week posttreatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of incontinent episodes measured by bladder diary	Record the frequency of day and night time voiding and incontinence episodes over 3 day periods	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.	1-week posttreatment, 4-week posttreatment
Medication measured by bladder diary	number of patients requested medication for OAB from bladder diary.	1-week posttreatment, 4-week posttreatment

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
AE measured by open-ended questions	open-ended questions about the experience of adverse events	first week of treatment, second week of treatment, third week of treatment, 1-week posttreatment, 4-week posttreatment

Collaborators and Investigators

• Sponsor: The University of Hong Kong
• Investigators: Principal Investigator: Wing Fai Yeung, BCM, PhD, The University of Hong Kong

Study record dates

Study Major Dates

• Study Start: August 1, 2015
• Primary Completion (Actual): August 1, 2018
• Study Completion (Actual): August 1, 2018

Study Registration Dates

• First Submitted: June 13, 2015
• First Submitted That Met QC Criteria: October 4, 2015
• First Posted (Estimate): October 6, 2015

Study Record Updates

• Last Update Posted (Actual): October 11, 2018
• Last Update Submitted That Met QC Criteria: October 10, 2018
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Keywords: Post-stroke
• Additional Relevant MeSH Terms: Urologic Diseases; Urinary Bladder Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Urinary Bladder, Overactive
• Other Study ID Numbers: AcupPSOAB