Cycling Study With the Axonics System

Overactive Bladder Syndrome Clinical Trial

Official title:

Cycling Study With the Axonics System

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05543382
• Other study ID #: 105-0095
• Status: Active, not recruiting
• Start date: August 9, 2022
• Est. completion date: February 29, 2024

Study information

• Verified date: December 2023
• Source: Axonics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 60
• Est. completion date: February 29, 2024
• Est. primary completion date: October 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Overactive Bladder Syndrome
• Sacral Neuromodulation
• Urinary Bladder, Overactive
• Urinary Incontinence, Urge
• Urinary Urge Incontinence

Intervention

Device:
• Axonics System
The Axonics System will be implanted as standard care

Locations

Country	Name	City	State
United States	University Hospitals-Cleveland Medical Center	Cleveland	Ohio
United States	Center for Pelvic Health	Franklin	Tennessee
United States	The Florida Bladder Institute	Naples	Florida
United States	LSU Health	New Orleans	Louisiana
United States	The Female Pelvic Health Center	Newton	Pennsylvania
United States	Urologic Specialists Oklahoma	Tulsa	Oklahoma

Sponsors (1)

Lead Sponsor	Collaborator
Axonics, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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