Sacral Neuromodulation Using a Novel Device with a Six-contact-point Electrode for the Treatment of Patients with Refractory Overactive Bladder: A Multicenter, Randomized, Single-blind, Parallel-control Clinical Trial.

BACKGROUND

A novel sacral neuromodulation system (SacralStim) which has an electrode with six contact points was recently designed.

OBJECTIVE

To evaluate the effectiveness and safety of the SacralStim system for treating patients with refractory overactive bladder (OAB).

DESIGN, SETTING, AND PARTICIPANTS: This was a multicenter, randomized, single-blind clinical trial. Patients with refractory OAB were enrolled from January 2018 to May 2020.

INTERVENTION

Participants were randomly allocated to the treatment group (SNM on) or the control group (SNM off) for a single-blind period of 12 ± 2 wk.

OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS

The primary outcome was the percentage of patients with a reduction in the average number of voids/24 h of at least 50% at the 12-wk follow-up visit. Other follow-up evaluations, including voiding diary outcomes, questionnaires on Overactive Bladder Symptom Score (OABSS), quality of life (QoL), device satisfaction, and causes of adverse events (AEs), were performed over the first 48 wk after implantation.

RESULTS AND LIMITATIONS

The therapeutic success rate at 12 wk was 56.76% in the treatment group and 11.11% in the control group (p < 0.001). There were significant differences in voiding diary variables between the two groups, including changes in the average number of voids/24 h, micturition volume/void, and improvement in the urge incontinence ratio. No severe AEs occurred. A limitation is the sham stimulation used as a control in the study. A head-to-head study is required to make a direct comparison of devices with six and four contact points.

CONCLUSIONS

This clinical trial provides strong evidence that patients with refractory OAB benefit from the novel SacralStim system. More research is required for direct comparison of the SacralStim system with traditional four-contact-point devices.

PATIENT SUMMARY

This study confirms the effectiveness and safety of a novel SacralStim system that stimulates the sacral nerve for treatment of overactive bladder. The system has an electrode with six contact points and can provide more programming options after implantation.