Trials / Terminated
TerminatedNCT05543382
Cycling Study With the Axonics System
- Status
- Terminated
- Phase
- —
- Study type
- Observational
- Enrollment
- 31 (actual)
- Sponsor
- Axonics, Inc. · Industry
- Sex
- All
- Age
- 21 Years
- Healthy volunteers
- Accepted
Summary
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.
Detailed description
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Axonics System | The Axonics System will be implanted as standard care |
Timeline
- Start date
- 2022-08-09
- Primary completion
- 2023-10-31
- Completion
- 2024-12-29
- First posted
- 2022-09-16
- Last updated
- 2025-04-02
Locations
6 sites across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT05543382. Inclusion in this directory is not an endorsement.