Chan Yu Tat, Zhang Hong Wei, Guo Yuan Qi, Chan Tony Ngai Ho, Kwan Yiu-Keung, Lee Chun-Kam, Ngan Kit, Lin Zhi-Xiu
School of Chinese Medicine, Faculty of Medicine, The Chinese University of Hong Kong, Shatin, New Territories, Hong Kong, China.
Pok Oi Hospital - The Chinese University of Hong Kong Chinese Medicine Centre for Training & Research (Shatin), New Territories, Hong Kong, China.
Trials. 2018 Jul 13;19(1):376. doi: 10.1186/s13063-018-2706-4.
Overactive 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/DESIGN: This 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.
The 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.
Chinese Clinical Trial Registry, ChiCTR-INR-16010048 . Registered on 29 Nov 2016.
膀胱过度活动症（OAB）的定义为“尿急，伴或不伴有急迫性尿失禁，通常伴有尿频和夜尿症”。针灸是治疗OAB最常用的替代疗法之一。目前几乎没有确凿证据支持针灸治疗OAB的有效性。本研究是一项开创性的随机、双盲、假针刺对照试验，旨在评估针灸对香港老年膀胱过度活动症患者的有效性和安全性。
方法/设计：这是一项随机、双中心、患者和结果评估者双盲、假针刺对照试验。研究样本量为100例患者。年龄在60至90岁之间的符合条件的受试者将被纳入本研究。所有受试者将按1:1的比例随机分配到真针灸组或假针灸组。分配到真针灸组的参与者在接受标准常规护理的基础上，将接受为期30分钟的标准化真针灸治疗，共16次，而随机分配到假针灸组的参与者除接受标准常规护理外，还将接受假针灸治疗。将使用非穿透性针作为假针灸。主要结局指标是7天排尿日记，次要结局指标是尿神经生长因子（NGF）水平、尿失禁影响问卷（IIQ-7）、泌尿生殖系统困扰量表（UDI-6）和OAB症状评分（OABSS）。所有结局指标将在基线、治疗结束时和治疗完成后3个月收集。
本研究的目的包括：（1）通过7天排尿日记评估针灸治疗OAB患者减少尿失禁发作频率的有效性和安全性；（2）评估针灸治疗是否能改善OAB患者的主观症状；（3）研究使用NGF作为膀胱过度活动症生物标志物的可行性，并测试其与针灸干预效果的相关性。本研究的结果将为针灸治疗OAB的有效性和安全性提供初步证据。
中国临床试验注册中心，ChiCTR-INR-16010048。于2016年11月29日注册。
