Clinical trial NCT05543382: Cycling Study With the Axonics System
Official title: Cycling Study With the Axonics System
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Overactive Bladder Syndrome
Urinary Urge Incontinence
Sacral Neuromodulation
Lead sponsor: Axonics, Inc.
Sponsor class: INDUSTRY
First posted: 2022-09-16
Enrollment: 31
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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

Primary outcomes:
measure: 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
timeFrame: 3 months
Secondary outcomes:
measure: To evaluate patient satisfaction with cyclic stimulation
timeFrame: 3 months
Other outcomes:
Locations:
city: Naples
country: United States
facility: The Florida Bladder Institute
state: Florida
city: New Orleans
country: United States
facility: LSU Health
state: Louisiana
city: Cleveland
country: United States
facility: University Hospitals-Cleveland Medical Center
state: Ohio
city: Tulsa
country: United States
facility: Urologic Specialists Oklahoma
state: Oklahoma
city: Newton
country: United States
facility: The Female Pelvic Health Center
state: Pennsylvania
city: Franklin
country: United States
facility: Center for Pelvic Health
state: Tennessee
Study officials:
affiliation: Axonics, Inc.
name: Karen Noblett, MD
role: STUDY_DIRECTOR
References: