Acupuncture on Post-Stroke Overactive Bladder

NCT02568774 | Completed

• 1 other identifier: AcupPSOAB
• Study Type: interventional
• Target: 34
• Locations: 2 countries
• Sites: 3

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.

Conditions

Overactive Bladder

Keywords

Post-stroke

Outcome Measures

Primary Outcomes (1)

• Overactive Bladder Symptom Scale (OABSS)

  four item questionnaire quantifies overactive bladder symptoms in a single score

  1-week posttreatment

Secondary Outcomes (3)

• Number of incontinent episodes measured by bladder diary

  1-week posttreatment, 4-week posttreatment

• Stroke Specific Quality of Life Scale (SS-QoLS)

  1-week posttreatment, 4-week posttreatment

• Medication measured by bladder diary

  1-week posttreatment, 4-week posttreatment

Other Outcomes (1)

• AE measured by open-ended questions

  first week of treatment, second week of treatment, third week of treatment, 1-week posttreatment, 4-week posttreatment

Study Arms (2)

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.

Other: Traditional Acupuncture

Usual Care

OTHER

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

Other: Usual Care

Interventions

Traditional Acupuncture OTHER

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.

Traditional Acupuncture

Usual Care OTHER

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

Usual Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• The University of Hong Kong: lead

Study Sites (3)

Shanghai TCM-INTEGRATED Hospital, Shanghai University of Traditional Chinese Medicine

Shanghai, China

Location

Tung Wah Eastern Hospital

Hong Kong, Hong Kong

Location

Tung Wah Hospital

Hong Kong, Hong Kong

Location

MeSH Terms

Conditions

Urinary Bladder, Overactive

Condition Hierarchy (Ancestors)

Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Wing Fai Yeung, BCM, PhD

  The University of Hong Kong

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant Professor

Study Record Dates

• First Submitted: June 13, 2015
• First Posted: October 6, 2015
• Study Start: August 1, 2015
• Primary Completion: August 1, 2018
• Study Completion: August 1, 2018
• Last Updated: October 11, 2018

Record last verified: 2018-10

Locations

HK (2); CN (1)