Axonics rechargeable sacral neuromodulation system (Model 5101 R20) for overactive bladder

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This post-market clinical follow-up enrolls adults with overactive bladder who have received the rechargeable Axonics SNM System INS Model 5101 (R20) to monitor long-term safety, device performance, and clinical benefit. Participants attend scheduled follow-up visits at participating centers where investigators collect safety data, device functioning metrics, and symptom/outcome measures. The protocol excludes patients with major neurological or psychiatric conditions that could confound results and patients previously deemed non-responders to sacral neuromodulation. The multicenter program includes sites in the United States and the United Kingdom and is sponsored by Axonics, Inc.

Why it matters

Who can join: the full rules

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 it's running

• University of Chicago
  Chicago, Illinois, United States Recruiting
• University of Missouri
  Columbia, Missouri, United States Recruiting
• Bradford Royal Infirmary
  Bradford, West Yorkshire, United Kingdom Recruiting
• Pinderfields Hospital
  Wakefield, West Yorkshire, United Kingdom Recruiting
• St James's University Hospital
  Leeds, United Kingdom Recruiting
• University College London Hospital
  London, United Kingdom Recruiting

Study contacts

• Principal investigator: Mahreen Pakzad, MD — University College London Hospitals
• Study coordinator: Caroline Beaudoint
• Email: Caroline.Beaudoint@bsci.com
• Phone: +32479904163

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Aquarius Pilot of the New Axonics External System for Bladder and Bowel Control

  This pilot will try the Axonics External Trial System in adults with overactive bladder or fecal incontinence to see if they respond to sacral neuromodulation before getting a permanent implant.

  Recruiting at 5 sites Axonics, Inc. · Birmingham, Alabama and 4 other locations · NCT07335484

• Predictive value of inflammatory biomarkers for mirabegron response in women with overactive bladder

  This study tests whether baseline blood inflammation markers can predict how well women with OAB respond to mirabegron after 3 months.

  Recruiting Bagcilar Training and Research Hospital · Istanbul, Bagcilar · NCT07773532

• NT 201 therapy delivered via the Vibe System for idiopathic overactive bladder

  This Phase 2b trial tests NT 201 given with the Vibe System to see if it helps adults with idiopathic overactive bladder compared to placebo or sham treatment.

  Recruiting at 3 sites Phase 2 Vensica Therapeutics Ltd. · Margate, Florida and 2 other locations · NCT07553065

• Ambulatory tibial nerve stimulation for overactive bladder in adults

  A portable nerve-stimulation device used at home is being tested to see if it can reduce urgency and improve bladder symptoms in adults with overactive bladder.

  Recruiting Başakşehir Çam & Sakura City Hospital · Istanbul, Istanbul · NCT07540273

• Low-intensity shockwave versus daily solifenacin for women's overactive bladder

  This test compares once-weekly low-intensity shockwave therapy with daily solifenacin to see which better reduces overactive bladder symptoms in adult women.

  Recruiting Phase 4 Mansoura University · Al Mansurah, Dakahlia Governorate · NCT07473310

• Low-dose tadalafil versus solifenacin for treating overactive bladder in women

  This trial will test whether taking daily low-dose tadalafil or daily solifenacin reduces overactive bladder symptoms in women aged 18–75.

  Recruiting at 14 sites Phase 4 Mansoura University · Shibīn al Kawm, Al-Minūfiyyah and 13 other locations · NCT07416968

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.