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PMCF Study of the Axonics SNM System Model 5101 (R20) for the Indication of OAB

Sponsor: Axonics, Inc.

NCT ID: NCT06789406

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Access to the study treatment being tested
Type of study
Interventional (receives a drug or procedure)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
Axonics SNM System INS Model 5101 (R20) (device)
How long the study runs
Study runs about 27 months (dates as stated)
About the drug or intervention
Axonics SNM System INS Model 5101 (R20) — device: Participants treated with the rechargeable Axonics SNM System Model 5101 also referred to as R20.
Patient visit burden
Not specified by the sponsor
Type of study
Testing a treatment
Ages
18 Years and over
Who
All
Number of participants
55
Started
2025-09-18
Last checked
2026-09

Plain English Summary

What is this study?

  • • Testing a new treatment for urinary urge incontinence (uui)
  • • NA - 55 participants
  • • 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

Who can take part?

  • • Ages 18 Years and over
  • • Diagnosed with urinary urge incontinence (uui)

Where?

  • • Bradford - Bradford Royal Infirmary
  • • Wakefield - Pinderfields Hospital
  • • Leeds - St James's University Hospital
  • • London - University College London Hospital

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

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.

More detail

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.

Urinary Urge Incontinence (UUI)Urinary Frequency (UF)Overactive Bladder (OAB)

How this trial compares with your answers

Answer 2 more questions to improve match

What we know so far

Condition· Matched your search
Age· Tell us your age for better matching
Gender· Tell us your sex for better matching

Still need:

  • • Tell us your age for better matching
  • • Tell us your sex for better matching

Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 18 Years and over
  • Who can join: All genders

Biomarkers mentioned

with a positive

What the study is looking for

  • ✓18 years or older
  • ✓Primary indication of OAB (urinary urgency incontinence (UUI) / urinary frequency (UF) who are not candidates for,...
  • ✓Willing and capable to provide written consent and agrees to comply with specified evaluations at clinical centers...

Who cannot take part

  • ✗History of allergic response to titanium, zirconia, polyurethane, epoxy, or silicone
  • ✗A female who is breastfeeding
  • ✗A female with a positive urine pregnancy test
See the full criteria
Inclusion Criteria: 1. 18 years or older 2. Primary indication of OAB (urinary urgency incontinence (UUI) / urinary frequency (UF) who are not candidates for, or who have failed conservative treatment 3. Willing and capable to provide written consent and agrees to comply with specified evaluations at clinical centers for all follow-up assessments Exclusion Criteria: 1. 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) 2. 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 3. 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) 4. History of allergic response to titanium, zirconia, polyurethane, epoxy, or silicone 5. A female who is breastfeeding 6. A female with a positive urine pregnancy test

Where Is This Study? (4 UK sites)

Bradford Royal Infirmary

Bradford BD96RJ, United Kingdom

Recruiting
Site contact (verified)
Elizabeth Kidger, MDPrincipal Investigator

Pinderfields Hospital

Wakefield WF1 4DG, United Kingdom

Recruiting
Site contact (verified)
Ased Ali, MDPrincipal Investigator

St James's University Hospital

Leeds, United Kingdom

Recruiting
Site contact (verified)
Andrei Kozan, MDPrincipal Investigator

University College London Hospital

London W1G 8PH, United Kingdom

Recruiting
Site contact (verified)
Mahreen Pakzad, MDPrincipal Investigator

How to Get in Touch

Caroline Beaudoint

Sponsor contact

CONTACT

+32479904163 Caroline.Beaudoint@bsci.com

Erum Shaikh

Sponsor contact

CONTACT

657-626-4310 Erum.Shaikh@bsci.com
Data sourced from ClinicalTrials.gov · Last verified: 2026-09