An observational study in Overactive Bladder Syndrome, Urinary Urge Incontinence and Sacral Neuromodulation, sponsored by Axonics, Inc.. Active, not recruiting at 6 sites in United States. Open to participants aged 21 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-08-09.
Sponsored by Axonics, Inc. · Observational
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.
855 studies on the registry are indexed under Urinary Bladder, Overactive; 125 are open to participants now.
This study's planned enrollment of 60 is below the median of 109 across 166 observational studies indexed under Urinary Bladder, Overactive.
Browse Urinary Bladder, Overactive studies →Axonics, Inc. is the lead sponsor of 9 studies on the registry; 4 are open to participants now.
Counted across the registry records on this site, refreshed daily.
The sample size will include 60 de novo participants with UUI, or currently implanted participants with UUI. Participants may be implanted with either the rechargeable or recharge-free Axonics Systems.
UUI episodes:
Exclusion Criteria:
This group will be participants with urinary urge incontinence (UUI) who have been previously implanted with an Axonics System and are satisfied with therapy
Device: Axonics System
This group will be participants who are newly implanted with an Axonics System.
Device: Axonics System
The Axonics System will be implanted as standard care
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
Plan to share: No
No publications or documents are linked to this record.
This study is active, not recruiting, as verified in Aug 2024. You cannot join it, but the record below documents what was studied.
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Axonics, Inc.