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Effectiveness and safety of acupuncture for elderly overactive bladder population in Hong Kong: study protocol for a randomized controlled trial.

ABSTRACT: 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.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.

SUBMITTER: Chan YT

PROVIDER: S-EPMC6045827 | biostudies-other | 2018 Jul

REPOSITORIES: biostudies-other

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Effectiveness and safety of acupuncture for elderly overactive bladder population in Hong Kong: study protocol for a randomized controlled trial.

Chan Yu Tat YT Zhang Hong Wei HW Guo Yuan Qi YQ Chan Tony Ngai Ho TNH Kwan Yiu-Keung YK Lee Chun-Kam CK Ngan Kit K Lin Zhi-Xiu ZX

Trials 20180713 1

<h4>Background</h4>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 K ...[more]

PMID: 30005707

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Project description:IntroductionOveractive bladder (OAB) is a symptom syndrome defined by the International Continence Society (ICS) as 'the presence of urinary urgency (both daytime and nighttime), usually accompanied by increased frequency and nocturia with or without urge urinary incontinence in the absence of a urinary tract infection or other obvious pathology'. Clinical studies indicate that acupuncture could reduce micturition over 24 h, urgency episodes over 24 h, and improve quality of life among people with OAB. This systematic review protocol details the proposed methods for evaluating the effectiveness and safety of acupuncture for OAB.Methods and analysisThe following databases will be searched for relevant studies: the Cochrane Central Register of Controlled Trials (CENTRAL), the Cochrane Incontinence Group Trials Register, MEDLINE, EMBASE, Chinese Biomedical Literature Database (CBM), Chinese Medical Current Content (CMCC), Chinese Scientific Journal Database (VIP database), Wan-Fang Data, and China National Knowledge Infrastructure (CNKI) and will hand search a list of medical journals as a supplement. Any randomised controlled trials in English or Chinese without restriction of publication status will be included with treatment of OAB. Outcomes will mainly include number of micturition episodes over 24 h, number of urgency episodes over 24 h and number of incontinence episodes over 24 h. Two reviewers will independently screen the titles, abstracts or even full texts, and extract data. Two other reviewers will assess study quality. Revman 5.1 software will be used to conduct meta-analysis and calculate the risk ratio for dichotomous data. Weighted mean difference or standard mean difference will be calculated for continuous data. The Cochrane collaboration's tool will be used to assess the risk of bias.DisseminationThis systematic review protocol will provide information on acupuncture therapy for OAB. The results will be disseminated through peer-reviewed publication or conference presentations.Protocol registrationPROSPERO CRD42014010181.

Project description:IntroductionPublic transport accessible to older people may offer a transformative solution to achieving healthy ageing. However, the evidence to support such transport infrastructure modifications is unclear. Previous studies on public transport use and elderly health were mostly observational studies using cross-sectional data. Few studies have examined the before-and-after effects of a new metro, for example, to see if it leads to improved elderly health.Methods and analysisWe use a new metro line in Hong Kong as a natural experiment to examine the impact of the metro-led public transport intervention on elderly health. In Hong Kong, more than 90% of daily travels are made by public transport. The public transport modifications consist of the new metro line with eight stations and changes in the walking environment and bus services around the stations. We will look at the before-and-after differences in public transport use and health outcomes between elderly participants living in treatment neighbourhoods (400 m walking buffered areas of the new metro stations) and in control groups (living in comparable areas but unaffected by the new metro). Questionnaire-based baseline data were collected in 2019 before the COVID-19 pandemic, while some qualitative interviews are ongoing. Amid the pandemic, we conducted a quick telephone-based survey of COVID-19's potential impact on public transport use behaviours of our elderly cohort in September 2020. Note there is no lockdown in Hong Kong until the writing of the paper (January 2021). After the new metro opens, we will conduct a follow-up survey, tentatively in late 2022. We aim to investigate if the new metro and the associated changes in the built environment have any effects on public transport use behaviours, physical activity and wider health outcomes among the elderly (eg, social inclusion, quality of life, subjective well-being).Ethics and disseminationThe Human Research Ethics Committee of the University of Hong Kong reviewed and approved the study procedures and materials (reference number: EA1710040). Results will be communicated through scientific papers and research reports.

Project description:BackgroundAcupuncture (AT) successfully regulates overactive bladder (OAB) symptoms. However, previous systematic reviews and meta-analyses have not provided sufficient evidence. This review presents the current evidence of the efficacy of AT in the management of OAB symptoms.Methods and analysesA total of 12 databases were searched from their inception: PubMed, EMBASE, Cochrane Central Register of Controlled Trials (CENTRAL), and AMED databases; five Korean medical databases; and three Chinese medical databases. Study selection, data extraction, and assessment were independently performed by two researchers. The risk of bias was assessed using the Cochrane risk of bias assessment tool. RevMan 5.4.1 software was used for data aggregation, and the Grades of Recommendations, Assessment, Development and Evaluation (GRADE) assessment was used to evaluate the quality of the study outcomes.ResultsA total of 30 studies were included in this review. Compared with the sham AT group, the AT group exhibited significant effects in reducing overactive bladder symptom scores (OABSS) [mean difference (MD): -1.13, 95% confidence interval (CI): -2.01 to -0.26, p = 0.01 I 2 = 67%] and urinary frequency [standardized mean difference (SMD): -0.35, 95% CI: -0.62 to -0.08, I 2 = 0%]. The AT group showed an equivalent effect as drug therapy in reducing OABSS (MD: -0.39, 95% CI: - 1.92 to 1.13, p = 0.61, I 2 = 94%) and urinary frequency (MD: 0.74, 95% CI: -0.00 to 1.48, p = 0.05, I 2 = 71%) with fewer adverse events [risk ratio (RR): 0.38, 95% CI: 0.16-0.92, p = 0.03, I2 = 58%]. The AT plus drug therapy group had a more favorable effect than drug therapy alone for reducing OABSS (MD: -2.28, 95% CI: -3.25 to -1.31, p < 0.00001, I 2 = 84%) and urinary frequency (MD: -2.34, 95% CI: -3.29 to -1.38, p < 0.00001, I 2 = 88%). The GRADE assessment demonstrated that the level of evidence was mostly low or very low given the high risk of bias and small sample sizes.ConclusionAT had more favorable effects than sham AT in reducing OAB symptoms. AT improved OAB symptoms as effectively as conventional drug therapy, and the combination of AT and drug therapy had more favorable effects than drug therapy alone. However, more rigorous studies are needed to enhance the level of evidence.Systematic review registrationhttp://www.crd.york.ac.uk/PROSPERO/display_record.php?ID=CRD42014010377, identifier: PROSPERO [CRD42014010377].

Project description:ImportanceFirst-line behavioral and drug therapies for overactive bladder (OAB) symptoms in men are effective but not usually curative.ObjectiveTo determine whether combining behavioral and drug therapies improves outcomes compared with each therapy alone for OAB in men and to compare 3 sequences for implementing combined therapy.Design, setting, and participantsIn this 3-site, 2-stage, 3-arm randomized clinical trial, participants were randomized to 6 weeks of behavioral therapy alone, drug therapy alone, or combined therapy followed by step-up to 6 weeks of combined therapy for all groups. Participants were recruited from 3 outpatient clinics and included community-dwelling men 40 years or older with urinary urgency and 9 or more voids per 24 hours. Data were collected from July 2010 to July 2015 and analyzed from April 2016 to September 2019.InterventionsBehavioral therapy consisted of pelvic floor muscle training with urge suppression strategies and delayed voiding. Drug therapy included an antimuscarinic (sustained-release tolterodine, 4 mg) plus an α-blocker (tamsulosin, 0.4 mg).Main outcomes and measuresSeven-day bladder diaries completed before and after each 6-week treatment stage were used to calculate reduction in frequency of urination (primary outcome) and other symptoms (ie, urgency, urgency incontinence, and nocturia). Other secondary outcomes included validated patient global ratings of improvement and satisfaction, Overactive Bladder Questionnaire score, and International Prostate Symptom Score.ResultsOf the 204 included men, 133 (65.2%) were white, and the mean (SD) age was 64.1 (11.1) years. A total of 21 men discontinued treatment and 183 completed treatment. Mean (SD) voids per 24 hours decreased significantly in all 3 groups from baseline to 6-week follow-up (behavioral therapy: 11.7 [2.4] vs 8.8 [2.1]; change, 2.9 [2.4]; percentage change, 24.7%; P < .001; drug therapy: 11.8 [2.5] vs 10.3 [2.7]; change, 1.5 [2.3]; percentage change, 12.7%; P < .001; combined therapy: 11.8 [2.4] vs 8.2 [2.3]; change, 3.6 [2.1]; percentage change, 30.5%; P < .001). Intention-to-treat analyses indicated that posttreatment mean (SD) voiding frequencies were significantly lower in those receiving combined therapy compared with drug therapy alone (8.2 [2.3] vs 10.3 [2.7]; P < .001) but not significantly lower compared with those receiving behavioral therapy alone (8.2 [2.3] vs 8.8 [2.1]; P = .19) and were lower for behavioral therapy alone compared with drug therapy alone (8.8 [2.1] vs 10.3 [2.7]; P < .001). At 12-week follow-up, after all groups had received combined therapy, improvements in mean (SD) voids per 24 hours were also greatest for those receiving initial combined therapy compared with baseline (behavioral therapy: 11.7 [2.4] vs 8.0 [2.2]; change, 3.7 [2.3]; percentage change, 31.6%; P < .001; drug therapy: 11.8 [2.5] vs 8.6 [2.3]; change, 3.2 [2.5]; percentage change, 27.1%; P < .001; combined therapy: 11.8 [2.4] vs 8.0 [2.2]; change, 3.8 [2.1]; percentage change, 32.2%; P < .001), but there were no statistically significant group differences on primary or secondary measures.Conclusions and relevanceCombining behavioral and drug therapy yields greater improvements in OAB symptoms than drug therapy alone but not behavioral therapy alone. When using a stepped approach, it is reasonable to begin with behavioral therapy alone.Trial registrationClinicalTrials.gov identifier: NCT01175382.

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Effectiveness and safety of acupuncture for elderly overactive bladder population in Hong Kong: study protocol for a randomized controlled trial.

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Effectiveness and safety of acupuncture for elderly overactive bladder population in Hong Kong: study protocol for a randomized controlled trial.

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