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.

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.

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.

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%.

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.

World journal of urology. 2019 Feb 26 [Epub ahead of print]

Yaoguang Zhang, Peng Zhang, Xiaojun Tian, Guoqing Chen, Yan Li, Yong Zhang, Zhihui Xu, Zhongqing Wei, Wei Zhang, Lulin Ma, Benkang Shi, Limin Liao, Jianye Wang

Urology Department, Beijing Hospital, National Center of Gerontology, No. 1 DaHua Road, Dong Dan, Beijing, 100730, People's Republic of China., Urology Department, Beijing Chaoyang Hospital, Capital Medical University, Beijing, 100020, People's Republic of China., Urology Department, Peking University Third Hospital, Beijing, 100191, People's Republic of China., Urology Department, China Rehabilitation Research Center, Capital Medical University, No. 10 North Road, Fengtai District, Beijing, 100068, People's Republic of China., Urology Department, Qilu Hospital, Shandong University, Jinan, Shandong, 250012, People's Republic of China., Urology Department, Beijing Tiantan Hospital, Capital Medical University, Beijing, 100050, People's Republic of China., Urology Department, Zhejiang Provincial People's Hospital, Hangzhou, Zhejiang, 310014, People's Republic of China., Urology Department, Second Affiliated Hospital of Nanjing Medical University, Nanjing, Jiangsu, 210000, People's Republic of China., Urology Department, China Rehabilitation Research Center, Capital Medical University, No. 10 North Road, Fengtai District, Beijing, 100068, People's Republic of China. ., Urology Department, Beijing Hospital, National Center of Gerontology, No. 1 DaHua Road, Dong Dan, Beijing, 100730, People's Republic of China. .

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