Zhang Yaoguang, Meng Lingfeng, Zhang Peng, Tian Xiaojun, Chen Guoqing, Li Yan, Zhang Yong, Xu Zhihui, Wei Zhongqing, Zhang Wei, Ma Lulin, Shi Benkang, Liao Limin, Wang Jianye
Urology Department, Beijing Hospital, National Center of Gerontology, Institute of Geriatric Medicine, Chinese Academy of Medical Sciences Beijing, China.
Peking University Fifth School of Clinical Medicine, Beijing, China.
Transl Androl Urol. 2021 May;10(5):1966-1975. doi: 10.21037/tau-21-43.
To evaluate the efficacy and safety of a novel remote programming sacral neuromodulation (SNM) system (BetterStim system) in the treatment of patients with refractory overactive bladder (OAB) for 3 years.
A total of 8 centers in China enrolled 84 patients with OAB. Following test stimulation 70 patients underwent implantation using BetterStim. All patients returned for follow-up at 3 and 6 months postoperatively. After that, the visits were conducted by telephone. Outcomes of voiding diaries, the overactive bladder symptom score (OABSS), questionnaires regarding OAB-related quality of life (OAB-qol), and adverse events (AEs) were evaluated at each visit. The clinical therapeutic success was defined as ≥50% improvement from baseline in any of the voiding diary variables or average voids/day return to normal voiding (<8 voids/day). The analysis is a modified Completers analysis.
At the 36-month follow-up, the success rate was 79% for overall OAB symptoms, 69% for urge urinary incontinence (UUI) and 42% for urgency frequency (UF). The average number of voids/day decreased from 29.2±14.9 at baseline to 17.6±11.2 at 3 years, the average volume/void increased from 94.7±54.2 to 151.4±80.8 mL, the urgency reduced from 3.0±1.4 to 1.8±1.7 (all P<0.001). For patients with urge incontinence, mean leaking episodes/day decreased from 8.1±7.6 at baseline to 2.1±3.5 at three years (P<0.05). The devices were explanted in 8 (11.4%) patients. There were no remote programming-related AEs or device-related serious AEs that occurred.
The Intermediate-term results demonstrated that BetterStim SNM system with remote programming is safe and effective for patients with refractory OAB.
评估一种新型远程程控骶神经调节（SNM）系统（BetterStim系统）治疗难治性膀胱过度活动症（OAB）患者3年的疗效和安全性。
中国8个中心共纳入84例OAB患者。在进行测试刺激后，70例患者使用BetterStim进行植入。所有患者在术后3个月和6个月返回进行随访。之后，通过电话进行随访。每次随访时评估排尿日记结果、膀胱过度活动症症状评分（OABSS）、关于OAB相关生活质量（OAB-qol）的问卷以及不良事件（AE）。临床治疗成功定义为排尿日记变量中任何一项较基线改善≥50%或平均每日排尿次数恢复正常排尿（<8次/天）。分析采用改良的完成者分析。
在36个月的随访中，总体OAB症状的成功率为79%，急迫性尿失禁（UUI）为69%，急迫性尿频（UF）为42%。平均每日排尿次数从基线时的29.2±14.9次降至3年时的17.6±11.2次，平均每次尿量从94.7±54.2 mL增至151.4±80.8 mL，急迫感从3.0±1.4降至1.8±1.7（均P<0.001）。对于急迫性尿失禁患者，平均每日漏尿次数从基线时的8.1±7.6次降至3年时的2.1±3.5次（P<0.05）。8例（11.4%）患者取出了装置。未发生与远程程控相关的AE或与装置相关的严重AE。
中期结果表明，具有远程程控功能的BetterStim SNM系统对难治性OAB患者安全有效。
