Cycling Study With the Axonics System

NCT ID: NCT05543382

Last Updated: 2025-04-02

Basic Information

• Recruitment Status: TERMINATED
• Total Enrollment: 31 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-08-09
• Study Completion Date: 2024-12-29

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.

Conditions

Overactive Bladder Syndrome; Urinary Urge Incontinence; Sacral Neuromodulation

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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

Axonics System

Intervention Type: DEVICE

The Axonics System will be implanted as standard care

De Novo group

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

Axonics System

Intervention Type: DEVICE

The Axonics System will be implanted as standard care

Interventions

Axonics System

The Axonics System will be implanted as standard care

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Axonics, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Karen Noblett, MD

Role: STUDY_DIRECTOR

Axonics, Inc.

Locations

The Florida Bladder Institute

Naples, Florida, United States

LSU Health

New Orleans, Louisiana, United States

University Hospitals-Cleveland Medical Center

Cleveland, Ohio, United States

Urologic Specialists Oklahoma

Tulsa, Oklahoma, United States

The Female Pelvic Health Center

Newton, Pennsylvania, United States

Center for Pelvic Health

Franklin, Tennessee, United States

Countries

United States

Other Identifiers

105-0095

Identifier Type: -

Identifier Source: org_study_id