Urinary Urge Incontinence (UUI)NCT06789406
PMCF Study of the Axonics SNM System Model 5101 (R20) for the Indication of OAB
A study testing Axonics SNM System INS Model 5101 (R20) in people with Urinary Urge Incontinence (UUI) and Urinary Frequency (UF), run by Axonics, Inc. at 6 sites in 2 countries.
Trial summary
Post-market clinical follow-up for continued assessment of safety and performance to confirm long-term outcomes of the Axonics SNM System INS Model 5101. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Urinary Urge Incontinence (UUI), Urinary Frequency (UF), Overactive Bladder (OAB)
- What is being tested?
- Axonics SNM System INS Model 5101 (R20)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 6 sitesin 2 countries
- Study dates
- 18 Sep 2025to Dec 2027
- Phase
- Interventional
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years or older
- Primary indication of OAB (urinary urgency incontinence (UUI) / urinary frequency (UF) who are not candidates for, or who have failed conservative treatment
- Willing and capable to provide written consent and agrees to comply with specified evaluations at clinical centers for all follow-up assessments
Who cannot join
- Any significant medical condition that is likely to interfere with procedures, device operation, or likely to confound evaluation of endpoints (i.e., neurological conditions such as multiple sclerosis)
- Any psychiatric or personality disorder that is likely to interfere with procedures at the discretion of the participating physician; this may include poor understanding or compliance with requirements
- Previously underwent an external sacral neuromodulation SNM trial and was deemed a non-responder or was previously implanted with a sacral neuromodulation device and did not get therapeutic benefit (a non-responder)
- History of allergic response to titanium, zirconia, polyurethane, epoxy, or silicone
- A female who is breastfeeding
- A female with a positive urine pregnancy test
Trial locations and contacts
6 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
6 sites in 2 countries
United Kingdom4 sites, 4 recruiting
- Recruiting
Bradford Royal Infirmary
Bradford, West Yorkshire, BD96RJ
Karen Regan
Stephen Cox
- Recruiting
St James's University Hospital
Leeds
Junyao Zhao
Andrei Kozan, MD
- Recruiting
University College London Hospital
London, W1G 8PH
Nadia Malabi
Mahreen Pakzad, MD
- Recruiting
Pinderfields Hospital
Wakefield, West Yorkshire, WF1 4DG
Toyin Familade
Ased Ali, MD
United States2 sites, 2 recruiting
- Recruiting
University of Chicago
Chicago, Illinois, 60637
Rowena Shi
Kimberly Kenton, MD
- Recruiting
University of Missouri
Columbia, Missouri, 65211
Kaycee Mackanos
Raymond Foster, MD
About this study
Official title: Post-Market Clinical Follow-up Study of the Rechargeable Axonics SNM System Model 5101 (R20) for the Indication of Overactive Bladder (OAB)
Post-market clinical follow-up for continued assessment of safety and performance to confirm long-term outcomes of the Axonics SNM System INS Model 5101.
Read the detailed description
This post-market clinical follow-up (PMCF) is conducted to assess the continued safety, device performance, and clinical benefit of the rechargeable Axonics SNM System INS Model 5101 also referred to as R20.
- Being tested
- Axonics SNM System INS Model 5101 (R20)
- Medical subject headings
- Urinary Incontinence, Urge, Urinary Bladder, Overactive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Axonics SNM System INS Model 5101 (R20)Device
Participants treated with the rechargeable Axonics SNM System Model 5101 also referred to as R20. Commercial devices used in this study are within their intended use as described in each geography's approved instructions for use.
| Study group | Role | What they receive |
|---|---|---|
| Overactive Bladder | Other | Participants with the Axonics SNM System Model 5101 and followed up regarding their overactive bladder symptoms. Receives: Device: Axonics SNM System INS Model 5101 (R20) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Performance/Effectiveness - Improvement in Qualify of Life scoring (OAB)
To demonstrate an improvement in Overactive Bladder Quality of Life using the International Consultation of Incontinence Questionnaire Overactive Bladder Qualify of Life (ICIQ-OABqol): questions in each subscale are scored by a summed range of 0 to 100, with a higher score indicating better quality of life. Overall score ≥ 10 points from baseline to follow-up is indicative of a clinically meaningful improvement.
Measured: 3 months
Adverse event reporting (Safety)
Device related, procedure-related and all serious adverse events
Measured: 3 months
Secondary outcomes (2)
Performance/Effectiveness - Improvement in Qualify of Life scoring (OAB)
To demonstrate an improvement in Overactive Bladder Quality of Life using the International Consultation of Incontinence Questionnaire Overactive Bladder Qualify of Life (ICIQ-OABqol): questions in each subscale are scored by a summed range of 0 to 100, with a higher score indicating better quality of life. Overall score ≥ 10 points from baseline to follow-up is indicative of a clinically meaningful improvement.
Measured: 12 months
Performance/Effectiveness - Improvement in Qualify of Life scoring (FI)
Cleveland Clinic Florida - Fecal Incontinence Score (CCF-FIS): scores range from 0 for full continence to 20 for complete incontinence. A higher score is indicative of the severity of fecal incontinence. Assessed if participant had a score of ≥6 at baseline.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2025
- Study start18 Sep 2025
- Primary completionJan 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urinary Urge Incontinence (UUI)Studies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 55 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Axonics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mahreen Pakzad, MD, Principal investigator, University College London HospitalsGita Ghadimi, OD, Study director, Boston Scientific Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06789406
- Sponsor's protocol ID
- 105-0104
- Status last verified
- Oct 2026
- First submitted
- 17 Jan 2025
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No