Abstract
BackgroundOveractive bladder (OAB) is defined as “urgency, with or without urge incontinence, usually with frequency and nocturia”. Acupuncture is one of the most popular alternative treatment methods for OAB. Little established evidence is available to support the effectiveness of acupuncture for OAB. This study is a pioneer randomized, double-blinded, sham-controlled trial to assess the effectiveness and safety of acupuncture in the elderly population with overactive bladder in Hong Kong.Methods/designThis is a randomized, double-center, patient and outcome assessor blinded, sham-controlled trial. The study sample size is 100 patients. Eligible subjects aged between 60 to 90 years old will be recruited into this study. All subjects will be randomly allocated into the active acupuncture group or sham acupuncture group in a 1: 1 ratio. Participants who are allocated into the active acupuncture group will receive a standardized 30-min real acupuncture treatment session for a total of 16 sessions on the top of standard routine care, whilst those who are randomized to the sham acupuncture arm will receive sham acupuncture in addition to standard routine care. Non-penetrating needles will be utilized as sham acupuncture. The primary outcome measure is the 7-day voiding diary and the secondary outcome measures are urine nerve growth factor (NGF) level, the Incontinence Impact Questionnaire (IIQ-7), Urogenital Distress Inventory (UDI-6) and OAB Symptom Score (OABSS). All outcome measures will be collected at baseline, the end of treatment and 3 months after treatment completion.DiscussionThe objectives of this study include (1) to evaluate the effectiveness and safety of acupuncture treatment in patients with OAB on reduction in the frequency of incontinence episodes as derived from a 7-day voiding diary, (2) to evaluate whether acupuncture treatment could improve subjective symptoms in patients with OAB and (3) to examine the feasibility of using NGF as a biomarker for overactive bladder and test correlation with the effectiveness of acupuncture intervention. The finding of this study will provide preliminary evidence on the effectiveness and safety of acupuncture for treatment of OAB.Trial registrationChinese Clinical Trial Registry, ChiCTR-INR-16010048. Registered on 29 Nov 2016.
Highlights
Overactive bladder (OAB) is defined as “urgency, with or without urge incontinence, usually with frequency and nocturia”
The secondary objectives are to evaluate the safety of acupuncture treatment, determine whether acupuncture treatment could improve the subjective symptoms in patients with OAB, as well as to examine the feasibility of using nerve growth factor (NGF) as a biomarker for overactive bladder and to test correlation between this and the effectiveness of the intervention
The economic expenditure in managing OAB is enormous according to the data from six industrialized countries, including Canada, Germany, Italy, Spain, Sweden and the UK [11]
Summary
Overactive bladder (OAB) is defined as “urgency, with or without urge incontinence, usually with frequency and nocturia”. This study is a pioneer randomized, double-blinded, sham-controlled trial to assess the effectiveness and safety of acupuncture in the elderly population with overactive bladder in Hong Kong. Overactive bladder, known as OAB, or overactive bladder syndrome, is defined as “urgency, with or without urge incontinence, usually with frequency and nocturia” by the International Continence Society (ICS) [1]. OAB dry is defined as having ≧ 4 episodes of urgency in the previous 4 weeks with either frequency > 8 times per day or the use of ≧ 1 coping behavior to control bladder function. In a recent study in Hong Kong, around 15% of the population was found to suffer from OAB [5]. OAB can cause severe social impact and lead to impaired quality of life for those sufferers [6]
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