Overactive Bladder SyndromeNCT05543382
Cycling Study With the Axonics System
An observational study of Overactive Bladder Syndrome and Urinary Urge Incontinence, run by Axonics, Inc. at 6 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Overactive Bladder Syndrome, Urinary Urge Incontinence, Sacral Neuromodulation
- What is being tested?
- Axonics System
- Type of treatment
- Medical device
- How many people
- 31 participants
- Where
- 6 sitesUnited States
- Study dates
- 9 Aug 2022to 29 Dec 2024
- How long will I take part?
- 3 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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)
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- 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
Who cannot join
- 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)
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- A patient who early discontinued from the ARTISTRY registry
- A female with a positive urine pregnancy test
- A female who is breastfeeding
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
University Hospitals-Cleveland Medical Center
Cleveland, Ohio, 44106
Center for Pelvic Health
Franklin, Tennessee, 37067
The Florida Bladder Institute
Naples, Florida, 34109
LSU Health
New Orleans, Louisiana, 70112
The Female Pelvic Health Center
Newton, Pennsylvania, 18940
Urologic Specialists Oklahoma
Tulsa, Oklahoma, 74146
About this study
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.
Read the 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.
- Being tested
- Axonics System
- Medical subject headings
- Urinary Incontinence, Urge
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Axonics SystemDevice
The Axonics System will be implanted as standard care
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Device: Axonics System | |
| De Novo group | This group will be participants who are newly implanted with an Axonics System. Receives: Device: Axonics System |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 3 months
Secondary outcomes (1)
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).
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2022
- Study start9 Aug 2022
- Primary completion31 Oct 2023
- Study completion29 Dec 2024
Why it stopped: Sponsor decision not to pursue additional sites and enrollments for this study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Overactive Bladder SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 31 participants (actual)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- Axonics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Karen Noblett, MD, Study director, Axonics, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05543382
- Sponsor's protocol ID
- 105-0095
- Status last verified
- Mar 2025
- First submitted
- 15 Aug 2022
- Last updated
- 2 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cycling Study With the Axonics System
- ClinicalTrials.gov ID
- NCT05543382
- Acronym / sponsor ID
- 105-0095
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Sponsor decision not to pursue additional sites and enrollments for this study.
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Axonics, Inc.Industry (pharma, biotech, devices)
- Study start
- 9 Aug 2022 (actual)
- Primary completion
- 31 Oct 2023 (actual)
- Study completion
- 29 Dec 2024 (actual)
- First posted
- 16 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Implanted group | – | Device: Axonics SystemThis group will be participants with urinary urge incontinence (UUI) who have been previously implanted with an Axonics System and are satisfied with therapy |
| De Novo group | – | Device: Axonics SystemThis group will be participants who are newly implanted with an Axonics System. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (9 listed)
- 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:
- Willing and capable of providing informed consent
Key exclusion criteria (9 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Axonics SystemThe Axonics System will be implanted as standard care | Device | De Novo group, Implanted group |
Primary outcome
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
Time frame: 3 months
Comparison of UUI episodes on a 3-day bladder diary at 3 months as compared to baseline UUI episodes
1 secondary outcome
To evaluate patient satisfaction with cyclic stimulation
Time frame: 3 months
Results and safety
The study was stopped early (reason given: Sponsor decision not to pursue additional sites and enrollments for this study.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Karen Noblett, MD study director
Axonics, Inc.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Overactive Bladder Syndrome and Urinary Urge Incontinence, run by Axonics, Inc. at 6 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 2 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Sponsor decision not to pursue additional sites and enrollments for this study.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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 (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2025.