Aims
Sacral neuromodulation (SNM) is a guideline‐recommended treatment for voiding dysfunction including urgency, urge incontinence, and nonobstructive retention as well as fecal incontinence. The Axonics® System is a miniaturized, rechargeable SNM system designed to provide therapy for at least 15 years, which is expected to significantly reduce revision surgeries as it will not require replacement as frequently as the non‐rechargeable SNM system. The ARTISAN‐SNM study is a pivotal study designed to treat patients with urinary urgency incontinence (UUI). Clinical results at 1‐year are presented.
Methods
A total of 129 eligible UUI patients were treated. All participants were implanted with a quadripolar tined lead and neurostimulator in a single procedure. Efficacy data were collected using a 3‐day bladder diary, a validated quality of life questionnaire (ICIQ‐OABqol), and a participant satisfaction questionnaire. Therapy responders were defined as participants with ≥50% reduction in UUI episodes compared to baseline. Data were analyzed on all 129 participants.
Results
At 1 year, 89% of the participants were therapy responders. The average UUI episodes per day reduced from 5.6 ± 0.3 at baseline to 1.4 ± 0.2. Participants experienced an overall clinically meaningful improvement of 34 points on the ICIQ‐OABqol questionnaire. All study participants (100%) were able to recharge their device at 1 year, and 96% of participants reported that the frequency and duration of recharging was acceptable. There were no serious device‐related adverse events.
Conclusions
The Axonics System is safe and effective at 1 year, with 89% of participants experiencing clinically and statistically significant improvements in UUI symptoms.
Introduction and hypothesis
The purpose of this pilot study was to evaluate the prevalence and associated risk factors for urinary incontinence in a Northern Plains tribe of American Indian women.
Methods
The Urogenital Distress Inventory-Short Form was used to assess urinary incontinence in a sample of American Indian women from one tribe. This was a cross-sectional convenience sampling of 234 eligible participants. Participant’s ages ranged from 18 to 80 years. Stata/Se 9.1 software was used in statistical analysis.
Results
The overall prevalence of urinary stress incontinence was 15.4%, urgency incontinence 2.14%, and mixed incontinence 20.5%. Both stress and urgency incontinence was found to be low in this sample population.
Conclusions
A reduced prevalence of stress and urgency incontinence is seen in our sample. Our study group showed a high prevalence of known risk factors associated with urinary incontinence. We intend to extend our study for further understanding of this patient population.
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