Cycling Study With the Axonics System

Terminated

• Conditions: Urinary Urge Incontinence; Sacral Neuromodulation; Overactive Bladder Syndrome
• Interventions: Device: Axonics System

• Registration Number: NCT05543382
• Lead Sponsor: Axonics, Inc.

Brief 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.

Study Timeline

• Study Start: 2022-08-09
• Study First Submitted: 2022-08-15
• Study First Submitted QC: 2022-09-14
• Study First Posted: 2022-09-16
• Primary Completion: 2023-10-31
• Study Completion: 2024-12-29
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-28
• Last Update Posted: 2025-04-02

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 31

Inclusion Criteria

1. Participants who are ≥ 21 years at the time of consent

2. Has a primary indication of UUI (participants with a secondary indication of UF or FI may also be enrolled)

3. Has a diagnosis of UUI for greater than or equal to 6 months prior to the date of consent

4. UUI episodes:

   1. For currently implanted participants (Group A), they must be considered therapy responders with a >50% reduction in UUI episodes (based on their original baseline diaries) and satisfied with their SNM therapy
   2. For de novo candidates (Group B), they must have completed a successful PNE documented with a >50% reduction in UUI episodes on a 3-day diary (a diary must exist within a medical record or equivalent)

5. Willing and capable of providing informed consent

6. Agrees to return to the site for all study visits

7. Fluent (able to speak and read) in English

Exclusion Criteria

1. Any participant that the study Investigator deems to be a poor candidate who is unable to complete a 72-hour bladder diary or will be non-compliant for study visits
2. Diagnosis of urinary retention
3. Surgical treatment for stress incontinence (e.g. sling, Burch), and/or pelvic organ prolapse in the past 3 months or recommended or planned within 3 months from the time of consent
4. Changes to current regimen of medications that could impact bladder function within 4 weeks prior to consent
5. Current urinary tract mechanical obstruction (e.g., benign prostatic enlargement or urethral stricture)
6. Current symptomatic urinary tract infection (UTI)
7. A patient who early discontinued from the ARTISTRY registry
8. A female with a positive urine pregnancy test
9. A female who is breastfeeding

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
De Novo group	Axonics System	This group will be participants who are newly implanted with an Axonics System.
Implanted group	Axonics System	This group will be participants with urinary urge incontinence (UUI) who have been previously implanted with an Axonics System and are satisfied with therapy

Primary Outcome Measures

Name	Time	Method
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	3 months	Comparison of UUI episodes on a 3-day bladder diary at 3 months as compared to baseline UUI episodes

Secondary Outcome Measures

Name	Time	Method
To evaluate patient satisfaction with cyclic stimulation	3 months	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).

Trial Locations

Locations (6)

The Florida Bladder Institute; 🇺🇸 Naples, Florida, United States

The Female Pelvic Health Center; 🇺🇸 Newton, Pennsylvania, United States

University Hospitals-Cleveland Medical Center; 🇺🇸 Cleveland, Ohio, United States

LSU Health; 🇺🇸 New Orleans, Louisiana, United States

Urologic Specialists Oklahoma; 🇺🇸 Tulsa, Oklahoma, United States

Center for Pelvic Health; 🇺🇸 Franklin, Tennessee, United States