Acupuncture on Post-Stroke Overactive Bladder

Overactive Bladder Clinical Trial

Official title:

Acupuncture on Post-Stroke Overactive Bladder: A Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02568774
• Other study ID #: AcupPSOAB
• Status: Completed
• Phase: N/A
• Start date: August 2015
• Est. completion date: August 2018

Study information

• Verified date: October 2018
• Source: The University of Hong Kong
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: August 2018
• Est. primary completion date: August 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Overactive Bladder
• Urinary Bladder, Overactive

Intervention

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.

Locations

Country	Name	City	State
China	Shanghai TCM-INTEGRATED Hospital, Shanghai University of Traditional Chinese Medicine	Shanghai
Hong Kong	Tung Wah Eastern Hospital	Hong Kong
Hong Kong	Tung Wah Hospital	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
The University of Hong Kong

Countries where clinical trial is conducted

China,  Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Primary	Overactive Bladder Symptom Scale (OABSS)	four item questionnaire quantifies overactive bladder symptoms in a single score	1-week posttreatment
Secondary	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
Secondary	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
Secondary	Medication measured by bladder diary	number of patients requested medication for OAB from bladder diary.	1-week posttreatment, 4-week posttreatment