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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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.
KeywordsElectric stimulation Urinary bladder Randomized controlled trial Overactive bladder Programming
This work was partially supported by the National Key R&D Program of China (Grant no. 2016YFC0105500) and the National Key R&D Program of China (Grant no. 2018YFC2002200).
JYW: protocol/project development, data collection and management, data analysis, and manuscript writing. YGZ: protocol/project development, data collection and management, data analysis, and manuscript writing. LML: protocol/project development, data collection and management, data analysis, and manuscript writing. PZ: protocol/project development, data collection and management, and data analysis. GQC: protocol/project development and data collection and management. YL: protocol/project development and data collection and management. YZ: protocol/project development and data collection and management. ZQW: protocol/project development and data collection and management. LLM: protocol/project development and data collection and management. XJT: protocol/project development and data collection and management. BKS: protocol/project development, data collection and management. ZHX: protocol/project development and data collection and management. WZ: protocol/project development and data collection and analysis.
Compliance with ethical standards
Conflict of interest
The authors declare that they have no competing interests.
All the procedures performed involving human participants were in accordance with the ethical standards of the institutional and national research committee and with the 1964 Helsinki Declaration and its later amendments or comparable ethical standards.
Informed consent was obtained from all individual participants included in the study.
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