To evaluate changes from baseline in urgency urinary incontinence (UUI) episodes, urinary frequency (UF) and quality of life through 12 weeks of percutaneous tibial neuromodulation (PTNM) therapy using NURO in drug-naïve OAB subjects.
Historically, providing SNM therapy required use of a non-rechargeable implantable pulse generator (IPG) with an average device lifespan of 4.4 years. Multiple device replacement surgeries are necessary with this device for long-term overactive bladder (OAB) management.
The InSite trial is a prospective, multicenter post-approval study of subjects receiving sacral neuromodulation (SNM) therapy with the InterStim® System. Enrolled subjects had bothersome symptoms of overactive bladder (OAB).
To evaluate therapeutic success rate, changes in quality of life (QOL) and safety with sacral neuromodulation (SNM) at 5 years after InterStim™ implant. Subjects with bothersome symptoms of overactive bladder (OAB) including urinary urge incontinence (UI) and/or urgency-frequency (UF), who had failed at least 1 anticholinergic medication and had at least 1 medication untried were included.
The primary aim of the RELAX-OAB study is to confirm the safety and efficacy of the Axonics r-SNM System, a miniaturized, rechargeable SNM system.
A total of 51 OAB patients were implanted in a single-stage implant procedure.
Sacral neuromodulation (SNM) therapy for overactive bladder (OAB) has proven long-term safety and efficacy. Historically, the only commercially available SNM device was nonrechargeable requiring replacement surgery due to battery depletion.
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