Cycling Study With the Axonics System

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Overactive Bladder Syndrome; Urinary Urge Incontinence; Sacral Neuromodulation
• Intervention / Treatment: Device: 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 Type: Observational
• Enrollment (Estimated): 60

Contacts and Locations

Study Locations

• United States
  • Florida
    • Naples, Florida, United States, 34109
      • The Florida Bladder Institute
  • Louisiana
    • New Orleans, Louisiana, United States, 70112
      • LSU Health
  • Ohio
    • Cleveland, Ohio, United States, 44106
      • University Hospitals-Cleveland Medical Center
  • Oklahoma
    • Tulsa, Oklahoma, United States, 74146
      • Urologic Specialists Oklahoma
  • Pennsylvania
    • Newton, Pennsylvania, United States, 18940
      • The Female Pelvic Health Center
  • Tennessee
    • Franklin, Tennessee, United States, 37067
      • Center for Pelvic Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

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.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
De Novo group; 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
Implanted group; 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; The Axonics System will be implanted as standard care

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	3 months

Collaborators and Investigators

• Sponsor: Axonics, Inc.
• Investigators: Study Director: Karen Noblett, MD, Axonics, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): August 9, 2022
• Primary Completion (Actual): October 31, 2023
• Study Completion (Estimated): February 29, 2024

Study Registration Dates

• First Submitted: August 15, 2022
• First Submitted That Met QC Criteria: September 14, 2022
• First Posted (Actual): September 16, 2022

Study Record Updates

• Last Update Posted (Estimated): December 19, 2023
• Last Update Submitted That Met QC Criteria: December 18, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urologic Diseases; Urinary Bladder Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Urination Disorders; Urinary Incontinence; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Urinary Bladder, Overactive; Urinary Incontinence, Urge
• Other Study ID Numbers: 105-0095

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes