A prospective, multi-center, study comparing continuous sacral neuromodulation (SNM) stimulation to daily cyclic stimulation of 2 hours "on" and 22 hours "off" using the Axonics System.
After consent is provided, the required visits are at Baseline, Day 0, 1-Month, and 3-Month. At the follow-up visits, a bladder diary is reviewed, symptoms are assessed, the PGI-I questionnaire is completed, and cyclic stimulation hours may be changed.
Study Type
OBSERVATIONAL
Enrollment
31
The Axonics System will be implanted as standard care
The Florida Bladder Institute
Naples, Florida, United States
LSU Health
New Orleans, Louisiana, United States
University Hospitals-Cleveland Medical Center
Cleveland, Ohio, United States
Urologic Specialists Oklahoma
Tulsa, Oklahoma, United States
To evaluate the efficacy of daily cyclic stimulation of 2 hours "on" and 22 hours "off" in reducing UUI episodes by > 50% in newly implanted participants, or maintenance of efficacy in currently implanted participants with an implanted Axonics System
Comparison of UUI episodes on a 3-day bladder diary at 3 months as compared to baseline UUI episodes
Time frame: 3 months
To evaluate patient satisfaction with cyclic stimulation
Analysis of the Patient Global Impression of Improvement (PGI-I) scale. This scale evaluates the post-operative condition. The PGI-I has 1 question with 7 possible answers ranging from "very much better" (score of 1) to "very much worse" (score of 7).
Time frame: 3 months
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The Female Pelvic Health Center
Newton, Pennsylvania, United States
Center for Pelvic Health
Franklin, Tennessee, United States