Cycling Study With the Axonics System

Last updated: March 28, 2025
Sponsor: Axonics, Inc.
Overall Status: Terminated

Phase

N/A

Condition

Interstitial Cystitis

Treatment

Axonics System

Clinical Study ID

NCT05543382
105-0095
  • Ages > 21
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

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 orFI may also be enrolled)

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

  4. UUI episodes:

  5. For currently implanted participants (Group A), they must be considered therapyresponders with a >50% reduction in UUI episodes (based on their originalbaseline diaries) and satisfied with their SNM therapy

  6. For de novo candidates (Group B), they must have completed a successful PNEdocumented with a >50% reduction in UUI episodes on a 3-day diary (a diary mustexist within a medical record or equivalent)

  7. Willing and capable of providing informed consent

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

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

Exclusion

Exclusion Criteria:

  1. Any participant that the study Investigator deems to be a poor candidate who isunable 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 organprolapse in the past 3 months or recommended or planned within 3 months from thetime 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 orurethral 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

Total Participants: 31
Treatment Group(s): 1
Primary Treatment: Axonics System
Phase:
Study Start date:
August 09, 2022
Estimated Completion Date:
December 29, 2024

Study 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.

Connect with a study center

  • The Florida Bladder Institute

    Naples, Florida 34109
    United States

    Site Not Available

  • LSU Health

    New Orleans, Louisiana 70112
    United States

    Site Not Available

  • University Hospitals-Cleveland Medical Center

    Cleveland, Ohio 44106
    United States

    Site Not Available

  • Urologic Specialists Oklahoma

    Tulsa, Oklahoma 74146
    United States

    Site Not Available

  • The Female Pelvic Health Center

    Newton, Pennsylvania 18940
    United States

    Site Not Available

  • Center for Pelvic Health

    Franklin, Tennessee 37067
    United States

    Site Not Available

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