Cycling Study With the Axonics System

NCT05543382 | Terminated FDA Device

• 1 other identifier: 105-0095
• Study Type: observational
• Target: 31
• Locations: 1 country
• Sites: 6

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.

Conditions

Overactive Bladder Syndrome; Urinary Urge Incontinence; Sacral Neuromodulation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• To evaluate patient satisfaction with cyclic stimulation

  3 months

Study Arms (2)

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

De Novo group

This group will be participants who are newly implanted with an Axonics System.

Device: Axonics System

Interventions

Axonics System DEVICE

The Axonics System will be implanted as standard care

De Novo group; Implanted group

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Participants who are ≥ 21 years at the time of consent
• Has a primary indication of UUI (participants with a secondary indication of UF or FI may also be enrolled)
• Has a diagnosis of UUI for greater than or equal to 6 months prior to the date of consent
• UUI episodes:
• 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
• 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)
• Willing and capable of providing informed consent
• Agrees to return to the site for all study visits
• Fluent (able to speak and read) in English

You may not qualify if:

• 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
• Diagnosis of urinary retention
• 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
• Changes to current regimen of medications that could impact bladder function within 4 weeks prior to consent
• Current urinary tract mechanical obstruction (e.g., benign prostatic enlargement or urethral stricture)
• Current symptomatic urinary tract infection (UTI)
• A patient who early discontinued from the ARTISTRY registry
• A female with a positive urine pregnancy test
• A female who is breastfeeding

Sponsors & Collaborators

• Axonics, Inc.: lead

Study Sites (6)

The Florida Bladder Institute

Naples, Florida, 34109, United States

Location

LSU Health

New Orleans, Louisiana, 70112, United States

Location

University Hospitals-Cleveland Medical Center

Cleveland, Ohio, 44106, United States

Location

Urologic Specialists Oklahoma

Tulsa, Oklahoma, 74146, United States

Location

The Female Pelvic Health Center

Newton, Pennsylvania, 18940, United States

Location

Center for Pelvic Health

Franklin, Tennessee, 37067, United States

Location

MeSH Terms

Conditions

Urinary Incontinence, Urge

Condition Hierarchy (Ancestors)

Urinary Incontinence; Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Karen Noblett, MD

  Axonics, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Months
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 15, 2022
• First Posted: September 16, 2022
• Study Start: August 9, 2022
• Primary Completion: October 31, 2023
• Study Completion: December 29, 2024
• Last Updated: April 2, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (6)