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Remotely programmed sacral neuromodulation for the treatment of patients with refractory overactive bladder: a prospective randomized controlled trial evaluating the safety and efficacy of a novel sacral neuromodulation device

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机构: [1]Urology Department, Beijing Hospital, National Center of Gerontology, No. 1 DaHua Road, Dong Dan, Beijing 100730, People’s Republic of China [2]Urology Department, Beijing Chaoyang Hospital, Capital Medical University, Beijing 100020, People’s Republic of China [3]Urology Department, Peking University Third Hospital, Beijing 100191, People’s Republic of China [4]Urology Department, China Rehabilitation Research Center, Capital Medical University, No. 10 North Road, Fengtai District, Beijing 100068, People’s Republic of China [5]Urology Department, Qilu Hospital, Shandong University, Jinan, Shandong 250012, People’s Republic of China [6]Urology Department, Beijing Tiantan Hospital, Capital Medical University, Beijing 100050, People’s Republic of China [7]Urology Department, Zhejiang Provincial People’s Hospital, Hangzhou, Zhejiang 310014, People’s Republic of China [8]Urology Department, Second Affiliated Hospital of Nanjing Medical University, Nanjing, Jiangsu 210000, People’s Republic of China [9]Peking University Fifth School of Clinical Medicine, Beijing 100730, People’s Republic of China
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关键词: Electric stimulation Overactive bladder Programming Randomized controlled trial Urinary bladder

摘要:
Purpose: The efficacy and safety of a novel remotely programmed BetterStim sacral neuromodulation (SNM) system was evaluated in patients with refractory overactive bladder (OAB) in a prospective, controlled, multicenter trial. Methods: A total of 84 patients referred for SNM therapy from October 2015 to January 2018 were studied. Of the patients who qualified for implantation, 37 and 33 were randomly assigned to treatment and control groups, respectively. Patients in the treatment group underwent stimulation upon implantation, while stimulation was delayed in the control group for 3 months. Follow-up visits, consisting of voiding diary outcome, questionnaires regarding overactive bladder symptom score (OABSS) and quality of life were conducted at 1, 3, and 6-month post-implantation. Results: Compared with the control group, subjects in the treatment group exhibited statistically significant improvement in OAB symptoms at 3 months. The overall success rate was achieved in 72% of the treatment group, compared with 12% of the control group at 3 months. At 6 months, there were no significant differences in key voiding diary variables between the two groups. Further, this study demonstrated sustained improvement in urinary symptom interference in OAB patients. In addition, nearly all patients expressed great satisfaction with the remote-programming methods. No serious adverse events occurred, and device-related adverse events rate was 12.86%. Conclusion: This clinical study demonstrates subjective and objective success of the BetterStim SNM system. Importantly, our data suggest that remote programming can be safely used as a viable option for the conventional programming with a high degree of patient satisfaction. © 2019, Springer-Verlag GmbH Germany, part of Springer Nature.

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出版当年[2018]版:
大类 | 3 区 医学
小类 | 3 区 泌尿学与肾脏学
最新[2023]版:
大类 | 2 区 医学
小类 | 2 区 泌尿学与肾脏学
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出版当年[2017]版:
Q2 UROLOGY & NEPHROLOGY
最新[2023]版:
Q2 UROLOGY & NEPHROLOGY

影响因子: 最新[2023版] 最新五年平均 出版当年[2017版] 出版当年五年平均 出版前一年[2016版] 出版后一年[2018版]

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第一作者机构: [1]Urology Department, Beijing Hospital, National Center of Gerontology, No. 1 DaHua Road, Dong Dan, Beijing 100730, People’s Republic of China [9]Peking University Fifth School of Clinical Medicine, Beijing 100730, People’s Republic of China
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通讯机构: [1]Urology Department, Beijing Hospital, National Center of Gerontology, No. 1 DaHua Road, Dong Dan, Beijing 100730, People’s Republic of China [4]Urology Department, China Rehabilitation Research Center, Capital Medical University, No. 10 North Road, Fengtai District, Beijing 100068, People’s Republic of China
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