Study on BlueWind RENOVA iStim System

A recent study found that the BlueWind RENOVA iStim system showed a good and long-term safety profile for the treatment of overactive bladder syndrome. The study was published in the journal "The Journal of Urology" 2020.

Overactive bladder syndrome affects a wide population across the globe and it occurs in the absence of urinary tract infection or other pathological conditions. Patients, who are mostly females, complain of debilitating urgency and frequency with or without urinary incontinence. Various treatment methods have been developed for the treatment of this condition. Of these different treatment procedures, implantable tibial nerve stimulator is one of them. Recently, BlueWind Medical RENOVA™ iStim system was developed for the treatment of overactive bladder syndrome.

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Researchers from various centers in Netherlands and London have evaluated the 3-year safety and efficacy of the BlueWind Medical RENOVA™ iStim system for the treatment of overactive bladder syndrome. The study was conducted with patients who underwent implantation with the RENOVA system. The authors evaluated the incidence of the serious system and/or procedure-related adverse events, which was measured by the impact and frequency of serious adverse events as a primary endpoint. The clinical improvement compared to baseline and quality of life improvement compared to baseline at 36 months was the secondary point of measurement. It was measured by a 3-day voiding diary and quality of life questionnaires at certain time points.

Key Findings of the Study

• Of the 34 patients with overactive bladder syndrome who previously underwent implantation with the RENOVA system, 20 consented to continuation in this 3-year follow-up study.
• The mean patient age was 56.1 years and 80% (16) of the study cohort was female.
• The overall treatment success rate was 75% at 36 months in the per-protocol (16) and the intent to treat (20) analyses.
• In total, 73% of the patients reported improvement in health-related quality of life scores above the minimal important difference of 10 points.

Thus, the researchers concluded that the 3-year follow-up study for the treatment of overactive bladder syndrome symptoms using the BlueWind RENOVA iStim system confirms the long-term good safety profile with no reported technical failures. They also mentioned that lasting treatment efficacy is mirrored by a sustained positive impact on patient quality of life.

For further reading, click the following link: 10.1097/JU.0000000000001024